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Recruiting Phase 1/2

Study of Orellanine in Metastatic Clear-Cell or Papillary Renal Cell Carcinoma

Carcinoma, Renal Cell

A phase I/II, open-label, study to determine the safety and preliminary efficacy of orellanine in patients with metastatic clear-cell or papillary renal carcinoma who have failed standard-of-care therapy. All participants must have end-stage kidney disease and be receiving stable chronic hemodialysis.

Начало: 04.08.2023 Край: 31.12.2027 Възраст: от 18 г.

Portugal, Sweden, United States Oncorena AB NCT05287945

Recruiting Phase 2

Phase II Study of Peptide Receptor Radionuclide Therapy in Combination With Immunotherapy for Patients With Merkel Cell Cancer

Merkel Cell Carcinoma

The purpose of this study is to find out what effects an immunotherapy drug, called pembrolizumab, combined with a radioactive drug, called lutetium Lu 177 dotatate (Lutathera®) have on patients with Merkel cell carcinoma. Pembrolizumab works by helping patient's immune system to fight cancer. Lutathera works by killing cancer cells. Pembrolizumab is approved by the FDA to treat Merkel cell cancer and has caused some Merkel cell cancers to shrink and/or resolve. Lutathera is FDA-approved to treat some neuroendocrine tumors and has caused some patient's neuroendocrine tumors to shrink and allowed them to live longer, but it is not approved by the FDA to treat Merkel cell cancer. The combination of Lutathera and pembrolizumab to treat Merkel cell cancer is investigational, which means this combination is not approved by the FDA to treat Merkel cell cancer.

Начало: 03.08.2023 Край: 01.12.2028 Възраст: от 18 г.

United States Weill Medical College of Cornell University NCT05583708

Recruiting

Virtual perI-/Menopause Registry of AusTrALia

Menopause Perimenopausal Disorder Postmenopausal Symptoms Health Knowledge, Attitudes, Practice +16

13 million (50.7%) Australians are born with ovaries, 14% (\~3 million) are currently aged 40-59 yrs, \& all such who live to midlife will experience menopause, defined as \>12 months without a period. Peri-menopause (peri), typically occurs 5 yrs before menopause as hormone levels decrease. As with oestrogen, peri symptoms can affect every bodily system; e.g. depression/anxiety, diminished mental function, irregular periods, hot flushes, sleep problems, vaginal atrophy \& urinary urgency. These symptoms are linked with lower quality of life \& significantly higher work impairment; a third experiencing symptoms so severe as to impede daily life \& increase risk of suicide. Lifetime increased risks of diabetes, heart disease, osteoporosis \& dementia are also associated with menopause, yet it remains disconcertingly poorly studied. The investigators propose to create a world-first, cutting-edge, consumer-driven, Virtual peri-/menopause registry of AusTrALia (VITAL). The unique design will enable consumers to determine VITAL's questions, encourage secure revelation of private data e.g. vaginal \& mental health symptoms, \& to direct priorities for research, education, \& health service improvements. VITAL will thus deliver optimal assessments of incidence, prevalence \& impact. The participating consumers, researchers, clinical specialists, policy makers, \& modern virtual data infrastructure enable this unique \& innovative registry design, future translation to improved community health, \& promote awareness \& collaborative synergies. Leveraging the investigators' critical range of expertise \& ongoing feedback opportunities for both participants \& stakeholder partnerships, the investigators will create a ground-breaking platform that: * empowers the consumer voice and priorities, * enables peri-/menopause research to extend beyond existing niche focuses, * evidences the true impact of peri-/menopause across the nation, * evolves healthcare services and outcomes, \& * educates community, clinicians, \& policy-makers. After Australian registry establishment, the investigators will expand VITAL to mirror it in other nations while still protecting individual's data the right way, but so all can learn \& apply the best aspects of care from across the world.

Начало: 03.08.2023 Край: 01.08.2073 Възраст: от 18 г.

Australia Bespoke Clinical Research NCT06487130

Recruiting Phase 1

Study of MT-302 in Adults With Advanced or Metastatic Epithelial Tumors

Epithelial Tumors, Malignant

MYE Symphony is a multicenter, open-label, Phase 1 first-in-human study to assess the safety, tolerability, and define the RP2D of MT-302 in participants with advanced epithelial cancer.

Начало: 02.08.2023 Край: 31.08.2028 Възраст: от 18 г. Treatment

Australia Myeloid Therapeutics NCT05969041

Recruiting

Trial of Enhanced Neurostimulation for Anorexia

Anorexia Nervosa

Preliminary open-label studies have suggested that non-invasive brain stimulation methods of both transcranial direct current stimulation (tDCS) and repetitive transcranial magnetic stimulation (rTMS) have clinical benefits for improving psychological and eating disorder related symptoms, which can persist at long-term follow ups after acute treatment (i.e., at 6 and 12 months). Here the investigators propose to conduct the first double-blinded, randomised sham-controlled study to directly compare the therapeutic effectiveness and acceptability of both treatment modalities. Participants will be recruited and treated at one inpatient setting (Northside Clinic, St Leonards, Sydney). This facility is one of the largest specialist eating disorder settings in Australia with approximately 130 new admissions every year (2019 data). All participants who give consent and who fulfill the eligibility criteria will be randomised to receive active tDCS, sham (placebo) tDCS, active rTMS or sham rTMS over 8 weeks. Trial participants, their treating psychiatrist, ward staff, and a study staff member (who will conduct blinded assessments of mood secondary outcome measures) will be blinded after assignment to intervention until the database is locked and the primary analysis completed. All participants will complete assessments of eating disorder symptoms, mood, psychological symptoms, neurocognition and functioning at baseline, end of week 4, 8 and 20. Expected outcomes include data on the relative effectiveness and acceptability for both treatment modalities in the inpatient and at-home setting (i.e., for at-home tDCS). The investigators expect that both active treatment arms will produce clinical benefits and have high acceptability, and that clinical benefits will be maintained with long-term at-home tDCS continuation treatment. These outcomes have potential to assist in reducing hospital stay and emergency re-admissions and improving day to day functioning in participants. Health economic data for both treatment modalities will additionally have utility from a service perspective, given the disparity in resource requirements between the two treatments (TMS, tDCS) in terms of costs for patients and access to treatment for people living in remote and rural areas (i.e., for at-home tDCS).

Начало: 02.08.2023 Край: 30.04.2026 Възраст: от 16 г. Treatment

Australia The George Institute NCT05788042

Recruiting Phase 3

Fosfomycin Versus Standard of Care in Children With Antibiotic-resistant Urinary Tract Infections

Urinary Tract Infections

Urinary tract infections (UTIs) are among the most common bacterial infections in children. Up to 50% of UTI's are caused by multi-drug resistant ESBL-producing gram negative bacteria that do not respond to treatment with oral penicillin's or cephalosporins. Instead, children often require hospital admission to receive broad-spectrum intravenous antibiotics when they may otherwise be safely managed at home; resulting in prolonged hospital stays and an increased use of health resources. Fosfomycin is a broad-spectrum antibiotic discovered in 1969 that remains susceptible to a large number of organisms due to its low international use. Fosfomycin can be prepared as an oral solution with an orange/tangerine flavour and is currently approved for use in females \>12 years old. Despite extensive evidence of its efficacy in adults and safety in neonates, the use of fosfomycin in children remains limited and fosfomycin is not currently licensed for use in children \

Начало: 02.08.2023 Край: 01.08.2027 Възраст: 6–17 г. Treatment

Australia University of Sydney NCT05709028

Recruiting

Stepcare Extended Follow-up Substudy

Cardiac Arrest With Successful Resuscitation Hypoxia, Brain Cognitive Impairment Caregiver Burden

To provide detailed information on long-term outcomes in relation to potential neuroprotection and improvements in recovery for different targets of sedation, temperature, and pressure management in post out of hospital cardiac arrest survivors at 6 and 12 months. In addition, the impact of caring for a post OHCA survivor will be explored.

Начало: 01.08.2023 Край: 31.07.2027 Възраст: от 18 г. Treatment

Australia, Belgium, Finland +6 Region Skane NCT06207942

Recruiting Phase 3

Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer

Colonic Neoplasms Neoplasms, Colon

The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair/ microsatellite instability high (dMMR/MSI-H) colon cancer.

Начало: 01.08.2023 Край: 27.03.2031 Възраст: от 18 г. Treatment

Argentina, Australia, Belgium +24 GlaxoSmithKline NCT05855200

Recruiting Phase 2

A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.

Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of zipalertinib in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) harboring EGFR ex20ins mutations and other mutations.

Начало: 31.07.2023 Край: 31.12.2028 Възраст: от 18 г. Treatment

Australia, Canada, France +9 Taiho Oncology, Inc. NCT05967689

Recruiting Phase 2

Guanfacine Extended-release for Adolescents With Cannabis Use

Cannabis Use Disorder

A randomized controlled trial to assess the efficacy of extended-release guanfacine to reduce cannabis use frequency in young people with cannabis use disorder following a period of monitored abstinence.

Начало: 27.07.2023 Край: 30.06.2026 Възраст: 12–25 г. Treatment

Australia Orygen NCT05957848

Recruiting

Clinical Evaluation of BCDx for Monitoring of Recurrence in Non-Muscle Invasive Bladder Cancer

Bladder Cancer

BCDx is a urine-based multi-omic assay for early cancer recurrence detection in patients with a history of bladder cancer. This prospective, blinded study evaluates its efficacy in detecting recurrent NMIBC, offering a noninvasive monitoring solution.

Начало: 26.07.2023 Край: 31.08.2026 Възраст: от 18 г.

United States Early is Good Inc. NCT05982561

Recruiting

EValuation Of poLygenic Scores and CT imAging In Risk Factor Modification in Patients With diabEtes

Cardiovascular Diseases Type 2 Diabetes Mellitus (T2DM)

This study is a three-arm, parallel-group, randomised controlled trial evaluating the effect of using cardiac CT imaging or polygenic risk score in cardiovascular risk factor modification in patients with diabetes.

Начало: 25.07.2023 Край: 01.08.2026 Възраст: от 40 г. Prevention

Australia Monash University NCT07091162

Recruiting Phase 1

AMT-116 in Patients With Advanced Solid Tumors

Advanced Solid Tumor

This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-116, in Patients with Advanced Solid Tumors

Начало: 25.07.2023 Край: 30.12.2026 Възраст: от 18 г. Treatment

American Samoa, Australia, United States Multitude Therapeutics Inc. NCT05725291

Recruiting Phase 1

Virtual Reality Mobility Assessment of Functional Vision in Retinal Disease

Cone-Rod Degeneration Rod-Cone Degeneration

Background: The retina is a thin layer of tissue at the back of the eye. Retinal disease usually reduces a person s mobility because it affects how he or she moves through familiar and unfamiliar environments. Researchers want to see if a virtual reality (VR) tool can provide an easier and more accurate way to assess mobility. Objective: To learn if researchers can track changes in mobility in people with retinal disease using a new VR tool. Eligibility: People aged 5 and older with retinal disease that affects their vision, and healthy volunteers. Design: Participants will have 2-3 clinic visits. Participants will wear goggles or sit in front of a screen while sitting. Using a game controller, they will navigate through 4 obstacle courses presented in VR. Participants will have a medical history exam. They will answer questions about their family history. They will fill out questionnaires about the vision and mobility issues they have in their daily lives. Participants will have a complete eye exam. They will read letters from a chart. Their eye pressure will be measured. Their pupils may be dilated with eye drops. Pictures of their eye will be taken. Lights will be shined in their eyes. Participants will take a visual field test. For this, they will look into a dome and press a button when they see a light. Participants will have an electroretinogram. For this, they will sit in the dark with their eyes patched. Then their eyes will be numbed with eye drops and they will wear contact lenses while watching flashing lights. Participants will have optical coherence tomography. This is a noninvasive procedure. It produces cross-sectional pictures of the retina....

Начало: 25.07.2023 Край: 31.12.2030 Възраст: 5–120 г. Diagnostic

Australia, United States National Eye Institute (NEI) NCT04289571

Recruiting

CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee

Revision Total Hip Arthroplasty (RTHA) Revision Total Knee Arthroplasty

The goal of this clinical trial is to compare two types of skin preparation solutions (chlorhexidine gluconate-alcohol solution and povidone-iodine solution) that help eliminate harmful bacteria on the skin at the time of surgery for patients having revision arthroplasty surgery of the hip or knee. The main outcome of interest for the definitive study is the need for re-operation for a wound complication or an infection of the prosthetic joint within one year after surgery. For the pilot trial, our main interest is to determine feasibility of a definitive trial. Feasibility outcomes will include: ability to recruit patients, ability to randomize patients, ability to collect complete data, estimate the event rate of our primary outcome, ability to carry out data linkages and determine the accuracy of collected data. Participants will be contacted at two time points after surgery to complete a 5-minute survey: after 30 days, and after 1 year.

Начало: 25.07.2023 Край: 01.11.2026 Възраст: от 18 г.

Canada Sunnybrook Health Sciences Centre NCT05828810

Recruiting

The Enteric Nervous System in Spinal Cord Injury: Study of the Enteric Nervous System and the Intestinal Epithelial Barrier Via Colonic Biopsies in Spinal Cord Injury Patients

Spinal Cord Injuries

The goal of this clinical trial is to learn more about the enteric nervous system (ENS) and the intestinal epithelial barrier (IEB) in patients with spinal cord injury (SCI). The main questions it aims to answer are : * to characterize the functional (permeability, serotonin production, enteric neuronal phenotype, etc.), proteomic (junction molecules) and transcriptomic (inflammation genes, neuromediator expression, etc.) remodeling of the colonic mucosa and ENS in SCI patients, in comparison with control data. * to correlate intestinal permeability (and all remodeling parameters) with the type of neurological impairment i.e. the neurological level of the lesion, quantification of neurological impairment (motor and sensory scores) and the completeness and incompleteness of a lesion. * to identify a link with disease severity markers * to identify therapeutic targets that could subsequently be tested in the animal model before being proposed in clinical trials. Participants will have colonic biopsies taken following a colonoscopy/rectosigmoidoscopy previously indicated for spinal cord injured patients. Biopsies will be obtained from the right and left colon.

Начало: 24.07.2023 Край: 01.10.2027 Възраст: 18–80 г.

France Nantes University Hospital NCT05954845

Recruiting

Omega Study: Evaluation of the Safety and Efficacy of the Omega System for the Treatment of BPH

Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms

The ProArc Medical Omega system is a prostatic reshaping device that is designed to treat Lower Urinary Tract Symptoms (LUTS) due to BPH. During the procedure an implant is delivered into the prostate tissue obstructing the urethra and restricting urine flow. The delivery system uses a static diathermy incision mechanism to make a circumferential incision in the tissue surrounding the prostatic urethra into which the Omega shaped permanent implant is placed. The implant expands the obstructed area, reducing the fluid obstruction through the prostatic urethra.

Начало: 23.07.2023 Край: 01.08.2026 Възраст: от 50 г. Treatment

Israel, New Zealand ProArc Medical NCT04627701

Recruiting Phase 3

Immunosuppression and COVID-19 Boosters

COVID-19

It is important people receiving immunosuppressive therapy are provided with the best protection against COVID-19 because they are at greater risk of severe illness should they become infected. As severe immunosuppression can reduce the efficacy of COVID-19 vaccination, doctors agree that COVID-19 boosters is are important to maximise the vaccine response in these people. However, we don't currently know the best time to give booster vaccines to people about to start immunosuppressive therapy. This research aims to address this knowledge gap by examining whether the greatest protection is provided by giving the COVID-19 booster just before the immunosuppressive therapy starts or by waiting and giving the booster 6 months after treatment start. At the 6-month timepoint, in many cases the more intensive immunosuppression is often weaning and the immune system is starting to rebuild.

Начало: 21.07.2023 Край: 31.12.2026 Възраст: от 18 г. Prevention

Australia Kirby Institute NCT05415267

Recruiting

Omuyambi: Traditional Healer Support to Improve HIV Viral Suppression in Rural Uganda

HIV Infections

This study aims to test a new approach to support people living with Human Immunodeficiency Virus (HIV) in Uganda. Traditional healers (TH) will be trained to provide counselling and testing for HIV, help patients start antiretroviral therapy quickly, and offer guidance on taking medications and staying in HIV care. This support will be given in addition to the regular care provided at clinics. The main goal of the study is to see if this new approach can help more people in rural areas achieve viral suppression.

Начало: 20.07.2023 Край: 01.01.2029 Възраст: от 18 г.

Uganda Weill Medical College of Cornell University NCT05943548

Recruiting

Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock

Critical Illness Shock

Aim The aim of the proposed RCT is to determine effectiveness of a strategy, where MAP (mean arterial blood pressure) targets during vasopressor therapy for shock in ICU are individualized based on patients' own pre-illness MAP that would be derived as an average of up to five most recent pre-illness blood pressure readings. Hypothesis We hypothesize that targeting a patient's pre-illness MAP during management of shock can minimize the degree of MAP-deficit (a measure of relative hypotension), which may help reduce the risk of 14-day mortality and major adverse kidney events by day 14 in ICU. Endpoints The primary endpoint will be the all-cause mortality rate at day 14. Secondary endpoints will be the time to death through day 14 and day 90, major adverse kidney events (MAKE-14), renal replacement therapy (RRT) free days until day 28, and 90-day all-cause mortality. Significance To date no major RCT has tested this strategy among ICU patients with shock. This pivotal trial will provide evidence to fulfil a crucial knowledge gap regarding a common and a fundamental intervention in critical care.

Начало: 20.07.2023 Край: 30.10.2028 Възраст: от 40 г. Prevention

Australia Rakshit Panwar NCT05850962

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