Clinical Research Directory

Safety of Anticoagulation Therapy in Cirrhotic Patients With PVT and Severe Thrombocytopenia

Severe thrombocytopenia (platelet count ≤ 50 × 10\^9/L) can significantly increase the risk of bleeding. Safety of Anticoagulation (AC) therapy in cirrhotic patients with portal vein thrombosis (PVT) and severe thrombocytopenia is unknown. Our study aimed to determine safety of AC therapy in cirrhotic PVT patients having platelet counts no less than 30×10\^9/L, especially in those with platelet counts between 30-50×10\^9/L.

Efficacy and Safety of AK104 Combined With Chemotherapy for Neoadjuvant Treatment of Advanced Ovarian Cancer

This is a randomized, controlled, multicenter clinical study to evaluate AK104 in FIGO 2018 stage III-IV ovarian cancer subjects who were assessed to be at high perioperative risk and/or unable to achieve R0 resection prior to initial treatment. The efficacy and safety of neoadjuvant therapy with intravenous infusion combined with chemotherapy compared with chemotherapy alone.

Safety, Tolerability, and Pharmacokinetics of RCS-21 in Healthy Volunteers.

The goal of this clinical trial is to evaluate the safety and tolerability of RCS-21 in healthy volunteers. Participants will be asked to inhale a single dose or multiple doses of RCS-21 and their health status will be constantly monitored.

An International Survey on the Use of NIV Outside the ICU

Non-invasive ventilation (NIV) is a way to support breathing using a mask or helmet instead of a breathing tube, and it is proven to reduce the need for intubation, save lives, shorten hospital stays, and lower costs. While NIV has long been used in intensive care units, it is now increasingly applied in emergency rooms, hospital wards, and long-term care facilities. However, global data on how it is used outside ICUs-such as which patients receive it, how well it works, and what barriers exist-is lacking. The NIV-Safety Study is a worldwide survey of doctors, nurses, and respiratory therapists to understand current practices, outcomes, and challenges of NIV use beyond the ICU. The findings aim to guide safer, more effective, and standardized use of NIV across different healthcare settings.

A First-in-Human SAD and MAD Study in HV to Evaluate Oral YR011 Tablet

This is a Phase I clinical trial (protocol number: YR-011-B07) sponsored by Hangzhou Yirui Pharmaceutical Technology Co., Ltd., focusing on the novel oral small-molecule drug YR011 (active ingredient: PA032, a Kv1.3 channel blocker). The trial aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of YR011 in healthy adult participants. The trial has two stages: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), with about 64 participants total (32 per stage). Participants are divided into 4 cohorts per stage (8 people per cohort), randomized 6:2 to receive YR011 or placebo in a double-blind manner. For the SAD stage, 4 dose levels are tested as a single oral dose under fasting conditions; for the MAD stage, 4 dose levels are given twice daily for 7 days plus one extra dose on Day 8. Key procedures include screening (up to 28 days before enrollment), baseline assessments, drug administration, and follow-up (7 days for SAD, 14 days for MAD). Safety is the primary endpoint (measured by treatment-related adverse events), with secondary endpoints including PK parameters (e.g., plasma concentration, half-life) and dose accumulation. Eligible participants are 18-60 years old, healthy, and able to comply with trial procedures; those with major diseases, drug allergies, or recent medication use are excluded. The trial follows ICH-GCP and FDA regulations, with a Safety Review Committee overseeing dose escalation and safety monitoring. All data is collected via electronic case report forms (eCRFs) and kept confidential.

To Evaluate the Safety and Efficacy of Hemay5394 in Patients With Mild to Moderate Atopic Dermatitis

Evaluate the safety and efficacy of Hemay5394 in patients with mild to moderate atopic dermatitis

A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)

A randomized, multicenter, open-label, active-controlled Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial vaginosis (BV).

Phase 1/2 Clinical Study of HY07121 Powder for Solution for Infusion in Patients With Advanced Solid Tumors

This is a multi-center, open-label, phase 1/2 study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HY07121 in participants with advanced solid tumors.

Simultaneous mRNA COVID-19 and IIV Vaccination in Pregnancy Study

This study is a prospective, randomized clinical trial. During this study, pregnant women will be randomly assigned to receive IIV and mRNA COVID-19 vaccine either simultaneously or sequentially (7-14 days apart). All participants will receive an mRNA COVID-19 vaccine at Visit 1 (Day 1). Solicited local and systemic symptoms of reactogenicity will be assessed on day of visit for Visits 1 and 2 and daily during the 6 days following each visit using either electronic or paper symptoms diaries, depending on study participant preference. Serious adverse events (SAE) and adverse events of special interest (AESI) will be collected throughout the duration of the study. Pregnant women will be followed through delivery with comprehensive obstetric and infant outcomes obtained from medical record review for 90 days post-delivery. Maternal serum samples will be collected for antibody titers relevant to Influenza and COVID-19 prior to vaccination, at Day 29 (both groups), as well as Days 36-43 if in sequential group. When feasible, maternal blood at delivery and cord blood serum will be analyzed for serological analyses of placental influenza and COVID-19 antibody transfer (cord blood: maternal antibody ratio) will be determined.

Radiotherapy Plus Anlotinib in LA-NSCLC Intolerable to cCRT

Concurrent chemoradiotherapy (cCRT) is the standard treatment for patients with negative epidermal growth factor receptor (EGFR)-mutated unresectable locally advanced non-small cell lung cancer (LA-NSCLC). However, parts of patients only receive sequential chemoradiotherapy (sCRT) due to various reasons. This phase II study aimed to improve the outcomes of patients receiving sCRT by combining anti-angiogenesis therapy (Anlotinib) during radiotherapy course.We hypothesize that the combination of radiotherapy with anlotinib could improve the 2-year PFS rate from 35% with sCRT to 50. The accrual target was 44 patients.

Prospective G7 Dual Mobility Total Hip PMCF

This is a prospective multi-center clinical evaluation following recipients of the G7 Dual Mobility hip device. The primary objective is to characterize survivorship of the G7 hip at five years post-index procedure. Secondary objectives include documentation of clinical outcomes, safety and radiographic data.

Safety and Efficacy of Papillary Versus NonPapillary Access During Percutaneous Nephrolithotomy

This study aims to evaluate and compare the safety, efficacy, and clinical outcomes of papillary and non-papillary renal access during percutaneous nephrolithotomy (PCNL), and to determine whether non-papillary puncture can be considered a safe and effective alternative to the conventional papillary approach in selected patients.

Evaluation of Allergenicity by HRIPT and Phototest

This clinical study will evaluate the dermatological safety and allergenic potential of a cosmetic product. The study will use the Human Repeat Insult Patch Test (HRIPT) and phototest procedures to assess whether the product may cause skin irritation, allergic reactions, photoirritation, or photosensitization after repeated use and exposure to ultraviolet light. Participants will receive applications of the investigational product under controlled conditions and will undergo dermatological evaluations throughout the study. The results will help determine the product's skin compatibility and safety for consumer use.

Long-Term PEA Safety Study

The goal of this clinical trial is to learn about the long term safety of PEA supplementation in healthy adults. This clinical trial will be in both males and females who are 18 years or older and are healthy volunteers. The main aim of the study is to assess the safety of long-term use of PEA by assessing the difference between the two groups for serious adverse events, non-serious adverse events, vital signs and biochemistry following 12 months of PEA supplementation. Participants will: * Have their suitability for the study checked against the full inclusion/exclusion criteria during the screening process. * Eligible participants will then complete a baseline visit where assessments will be performed and the participant will be randomly assigned to receive the study product or a placebo. Participants will then consume their assigned study product every day for 12 months. Participants will not know what product they have been assigned during the study. * Following the baseline visit, there will be 4 visits over 12 months. On months where participants do not have a visit there will be a check in phone call. * During visits there will be safety assessments performed, blood sampling and questionnaires. The trial will include two participation modes: 1. In-clinic participation (Brisbane): Participants will attend all visits in-person at the RDC Clinical facility. 2. Remote participation for participants outside of Brisbane: A subgroup of up to 120 participants will participate remotely with virtual visits and at-home assessments. Participants will attend their local pathology centre for blood sampling.

Safety and Tolerability of IRL757 in Participants With Parkinson's Disease and Apathy

This clinical trial's goal is to evaluate if the IRL757 is safe and has a good tolerability in participants with Parkinson's disease and experiencing apathy (a lack of interest or motivation). In addition, the trial is aiming to learn if IRL757 has effects on the symptoms of Parkinson's disease. Researchers will compare the effects of IRL757 to a placebo (a look-alike substance that contains no drug). Participants who fit the study criteria will be treated with the study drug (either the active drug IRL757 or placebo) for 12 weeks and will visit the clinic at 5 defined timepoints for check-ups and tests. A follow-up call after the end of treatment will be done 4 weeks after the last study drug intake.

Hodgkin Lymphoma Treatment With Adcetris and Levact in the Old Patient

Treatment outcome with ABVD in elderly patients remains inferior to adults. Moreover, Bleomycin-induced lung toxicity in the elderly has been reported as high as 46%. For these reasons, questions arise whether ABVD could be still considered the standard treatment in HL patients aged \> than 60. Regimens containing other alkylators such as CHOP proved even superior to ABVD, with a 3-y PFS of 67%. Frontline treatment of advanced-stage HL with Brentuximab Vedotin (BV) in association with AVD (Doxorubicin, Vinblastine, Dacarbazine) proved very active in a pioneer study, reporting the preliminary results of a phase 1 multicentre trial, in which the percentage of patients achieving CR was as high as 92%. For all these reason the investigators decided to test the association of an alkylator with an innovative mechanism of action and a very safe toxicity profile in the elderly such as Bendamustine (Be) with BV in untreated elderly HL patients. The combination of BV and Be, investigated in this study, might represent an innovative treatment alternative for HL patients older than 60 years of age, especially for those of them in whom ABVD chemotherapy, the current standard front-line treatment, is not suitable. However, even when ABVD is given as upfront treatment for elderly HL patients, it is associated with substantial dose reduction, treatment delay, toxicity, and treatment-related mortality, with treatment outcomes remaining much inferior to those obtained in younger patients. This drug association is expected to be safe, well-tolerated and to demonstrate higher efficiency compared with ABVD. In this setting, it is expected that this therapy could be offered to the large majority of elderly patients with a full treatment completion reached in up to 80% of these patients. Thus, the aim of this study will be to assess safety and efficacy of the above association.

Phase 1/2 Clinical Study of HY07121 for Injection (Subcutaneous) in Patients With Advanced Solid Tumors

This is a multi-center, open-label, phase 1/2 study to evaluate the safety, efficacy, and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HY07121 for Injection (Subcutaneous) in participants with advanced solid tumors.

A First-in-Human SAD and MAD Study in Healthy Participants to Evaluate Oral YR011 Tablet

This is a Phase I clinical trial (protocol number: YR-011-B01) sponsored by Hangzhou Yirui Pharmaceutical Technology Co., Ltd., focusing on the novel oral small-molecule drug YR011 (active ingredient: PA032, a Kv1.3 channel blocker). The trial aims to evaluate the safety, tolerability, and pharmacokinetics (PK) of YR011 in healthy adult participants. The trial has two stages: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), with about 64 participants total (32 per stage). Participants are divided into 4 cohorts per stage (8 people per cohort), randomized 6:2 to receive YR011 or placebo in a double-blind manner. For the SAD stage, 4 dose levels are tested as a single oral dose under fasting conditions; for the MAD stage, 4 dose levels are given twice daily for 7 days plus one extra dose on Day 8. Key procedures include screening (up to 28 days before enrollment), baseline assessments, drug administration, and follow-up (7 days for SAD, 14 days for MAD). Safety is the primary endpoint (measured by treatment-related adverse events), with secondary endpoints including PK parameters (e.g., plasma concentration, half-life) and dose accumulation. Eligible participants are 18-60 years old, healthy, and able to comply with trial procedures; those with major diseases, drug allergies, or recent medication use are excluded. The trial follows ICH-GCP and FDA regulations, with a Safety Review Committee overseeing dose escalation and safety monitoring. All data is collected via electronic case report forms (eCRFs) and kept confidential.

Tamsulosin Monotherapy Versus Combination Therapy With Tadalafil (2.5 mg vs 5 mg) in Managing Male LUTS Secondary to BPH

This study aims to evaluate the short-term impact and clinical outcomes of tamsulosin monotherapy versus combination therapy with tamsulosin plus tadalafil (2.5 mg vs. 5 mg) on lower urinary tract symptoms (LUTS) severity and patient quality of life in men with benign prostatic hyperplasia (BPH). It also seeks to determine whether the lower tadalafil dose provides adequate symptom relief while minimizing adverse effects over a 12-week follow-up period.

Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination

This is a Phase 1, open-label, three-part, study in approximately 96 healthy adult participants between 18 and 55 years of age (both inclusive) (16 participants in Part 1, 20 participants in Part 2 and , and approximately 60 participants in Part 3). The study will be conducted at one clinical site in the United States. Participants in Part 1 and Part 2 may be conducted in parallel. The duration of an individual participation will be approximately 46 days for Part 1 , 43 days for Part 2 and 83 days for Part 3. All participants in Parts I und 2 will be screened within 28 days prior to dosing. All participants in Part 3 will be screened within 33 days prior to dosing. They will be admitted to the clinical research unit (CRU) the day prior to dosing and will remain in the CRU until the end of the PK sample collection period. All participants will return to the clinic for follow-up assessments 7 days ± 1 day after the last dose of study intervention. Participants in Part 3 will also return to the clinic for follow-up assessments 28 days ± 2 days and 42 days ± 2 days after the last dose of study intervention.

Safety and Tolerability of Oral Supplementation With 1 mg of KGA-10 Daily (a Novel Environmentally-derived Mycolicibacterium) - a Pilot Study

The goal of this clinical trial is to learn if a novel strain of heat-killed Mycolicibacterium that is being considered by the International Code of Nomenclature of Prokaryotes (ICNP) as candidate species and type strain "Candidatus Mycolicibacterium petrae" KGA-10 (KGA-10) is safe and well tolerated for healthy adults. This novel Mycolicibacterium species is also referred to as NeuroAlly and MTC 0012. The questions it aims to answer are: 1) is KGA-10 associated with adverse side effects and 2) is KGA-10 well tolerated. Researchers will compare daily KGA-10 (1 mg mixed with microcrystalline cellulose in capsule form) to a placebo (microcrystalline cellulose in capsule form, but contains no KGA-10) to examine any adverse side effects and tolerability of KGA-10 relative to placebo. Participants will take KGA-10 or a placebo everyday for 1 week and keep a daily log of their supplement intake that includes the time of day. Participants will complete the Generic Assessment of Side Effects - Probiotics (GASE-P)\* survey to assess side effects experienced during the trial both related and not related to the supplement at baseline, 2 hrs following their first dose, 24 hrs following their first dose, and on day-7. Participants will complete the Treatment Satisfaction Questionnaire for Medication (TSQM) survey to assess tolerability/satisfaction of the supplement at 2 hrs following their first dose, 24 hrs following their first dose, and on day-7. \*Survey was modified by replacing the work "probiotic" with "postbiotic" for accuracy.

Comparison of the Analgesic Effect of Oliceridine Versus Morphine or Sufentanil for Postoperative Analgesia in Lumbar Surgeries: a Randomized Control Trial

Objective: This study aimed to compare the efficacy and safety of oliceridine versus morphine and sufentanil for postoperative analgesia following elective lumbar spine surgery. Methods: In this randomized, controlled trial, 90 patients scheduled for lumbar spine surgery were allocated in a 1:1:1 ratio to receive postoperative intravenous patient-controlled analgesia (PCIA) with either oliceridine (Group O，1.5mg oliceridine for loading dose， 0.5mg/kg oliceridine for PICA), morphine (Group M，4mg morphine for loading dose，1.5mg/kg morphine for PICA), or sufentanil (Group S，4ug sufentanil for loading dose，1.5ug/kg sufentanil for PICA). The primary outcome was the movement Visual Analogue Scale (VAS) score at 6 hours postoperatively. Secondary outcomes included resting and movement VAS scores, ramsay sation score at 0.5, 2, 6, 12, 24, and 48 hours postoperatively (excluding the motor VAS score at 6 hours postoperatively); number of PCIA demands and rescue analgesic requirements within 48 hours; hemodynamic parameters at 5, 10, 15, 30, and 60 minutes after administration of the initial loading dose. The incidence of adverse events within 48 hours postoperatively, such as nausea and vomiting, somnolence, respiratory depression, or pruritus.

Oral Supplementation With 1 mg of KGA-10 Daily (a Novel Environmentally-derived Mycolicibacterium) for Stress, Sleep, and Inflammation

The goal of this clinical trial is to learn if a novel strain of heat-killed Mycolicibacterium that is being considered by the International Code of Nomenclature of Prokaryotes (ICNP) as candidate species and type strain "Candidatus Mycolicibacterium petrae" KGA-10 (KGA-10) has effects on perceived stress, systemic inflammation, self-reported measures of sleep, and self-reported general well-being in healthy adults. This clinical trial will also learn about safety and tolerability of KGA-10. This novel Mycolicibacterium species is also referred to as NeuroAlly and MTC 0012. The questions it aims to answer are: 1) is KGA-10 associated with adverse side effects; 2) does KGA-10 reduce systemic inflammation; 3) does KGA-10 reduce perceived stress; 4) does KGA-10 improve self -reported measures of sleep; 4) does KGA-10 improve self-reported metrics of general wellbeing. Researchers will compare daily KGA-10 (1 mg mixed with microcrystalline cellulose in capsule form) to a placebo (microcrystalline cellulose in capsule form, but contains no KGA-10) to see if KGA-10 has effects on the proposed outcomes. Participants will take KGA-10 or a placebo everyday for 8 weeks and keep a daily log of their supplement intake that includes the time of day. Participants will complete a weekly survey to assess side effects experienced during the trial both related and not related to the supplement. They will complete additional weekly surveys evaluating perceived stress and self-reported measures of sleep. They will complete a survey evaluating self-reported general well-being and provide dried blood spot (DBS) samples to assess systemic inflammation at baseline, week-4, and week-8

"Safety in Dementia": An Online Caregiver Intervention

In an online randomized trial of Safety in Dementia with national recruitment and longitudinal follow-up, we will recruit informal caregivers of community-dwelling adults with dementia who have firearm access.