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NCT ID: NCT05292989 Recruiting - Clinical trials for Gastrointestinal Diseases

A Personalised Approach Utilising the Frailty Index to Empower Consumers

Start date: August 14, 2023
Phase: N/A
Study type: Interventional

Frailty is a common clinical syndrome in older adults that may carry an increased risk for poor health outcomes including falls, hospitalisation, and mortality. Having a colonoscopy can be associated with potential adverse outcomes in frail patients. At present, however, frailty is not routinely assessed in gastroenterological clinical practice. In a prospective randomised controlled study consenting patients over 65 years at the Princess Alexandra Hospital will receive either a) personalised (tailored) approach that includes assessment of frailty and structured information provided to the consumer or b) current standard practice in regards to having a surveillance colonoscopy to determine the effects on patient satisfaction and percentage of colonoscopies avoided.

NCT ID: NCT05292950 Recruiting - Asthma Clinical Trials

Study of ARO-MUC5AC in Healthy Subjects and Patients With Muco-Obstructive Lung Disease

Start date: June 27, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of ARO-MUC5AC in normal healthy volunteers (NHVs), patients with moderate-to-severe asthma and patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). In part 1 NHVs will receive a single dose of ARO-MUC5AC or placebo. In part 2 of the study, NHVs, adult patients with asthma, and adult patients with COPD will receive 3 doses of ARO-MUC5AC or placebo.

NCT ID: NCT05290597 Recruiting - Clinical trials for Solid Malignancies or Lymphomas

A Phase 1, Open-label, Multicenter, Dose Escalation Study of IBI363 (PD1-IL2m) in Subjects With Advanced Solid Malignancies or Lymphomas

Start date: August 22, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, multicenter, dose-escalation study designed to evaluate the safety, tolerability, and DLTs to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD), and the RP2D of sequential doses of IBI363 (study drug) in subjects with advanced, refractory solid malignancies or lymphomas.

NCT ID: NCT05288543 Not yet recruiting - Atopic Dermatitis Clinical Trials

A Study of Orally Administered IPG7236 in Healthy Adult Participants

Start date: April 11, 2022
Phase: Phase 1
Study type: Interventional

The study is a phase 1, randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetic and food effect of orally administered IPG7236 in healthy adult participants.

NCT ID: NCT05288166 Active, not recruiting - Prostatic Neoplasms Clinical Trials

A Study of Abemaciclib (LY2835219) With Abiraterone in Men With Prostate Cancer That Has Spread to Other Parts of the Body and is Expected to Respond to Hormonal Treatment (Metastatic Hormone-Sensitive Prostate Cancer)

CYCLONE 3
Start date: April 14, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. Participation may last approximately 60 months.

NCT ID: NCT05287893 Completed - Malaria Clinical Trials

Pyronaridine in Healthy Adult Participants Infected With Blood Stage Malaria

Start date: April 4, 2022
Phase: Phase 1
Study type: Interventional

This is an open-label, adaptive study that will utilise the P. falciparum induced blood stage malaria (IBSM) model to characterise the pharmacokinetic/pharmacodynamic (PK/PD) profile of pyronaridine. Up to 18 healthy, malaria naïve adult participants are planned to be enrolled into this study, in cohorts of up to six participants each. Following a screening period of up to 28 days, cohorts of up to 6 healthy participants will be enrolled. Each participant will be inoculated intravenously on Day 0 with P. falciparum infected erythrocytes. Participants will be followed up daily on Days 1 to 3, and will attend the clinical unit once on Days 4, 5, 6 and 7 for clinical evaluation and blood sampling. Participants will be admitted to the clinical trial unit on Day 8 for a single oral dose of pyronaridine. Different doses of pyronaridine will be administered across and within cohorts. Participants will be randomised to a dose group on the day of dosing. The highest dose of pyronaridine administered will be no more than 720 mg; the lowest dose administered will be no less than 180 mg. Each subsequent cohort will be composed of up to 3 dose groups. The Safety Data Review Team (SDRT) will review all available safety and tolerability data from the previous cohort/s prior to inoculation of the next cohort. Participants will be confined in the clinical unit for at least 96 h (Days 8 - 12) to monitor the safety and tolerability of pyronaridine dosing. Upon discharge from the clinical unit participants will be monitored on an outpatient basis up to Day 50±2. Participants will receive compulsory antimalarial rescue treatment with Riamet® (artemether/lumefantrine) on Day 47±2 or earlier.

NCT ID: NCT05286801 Recruiting - Clinical trials for Malignant Solid Neoplasm

Tiragolumab and Atezolizumab for the Treatment of Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors

Start date: November 17, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies how well tiragolumab and atezolizumab works when given to children and adults with SMARCB1 or SMARCA4 deficient tumors that have either come back (relapsed) or do not respond to therapy (refractory). SMARCB1 or SMARCA4 deficiency means that tumor cells are missing the SMARCB1 and SMARCA4 genes, seen with some aggressive cancers that are typically hard to treat. Immunotherapy with monoclonal antibodies, such as tiragolumab and atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

NCT ID: NCT05286788 Recruiting - Clinical trials for Recurrent Adamantinomatous Craniopharyngioma

MEKTOVI® for the Treatment of Pediatric Adamantinomatous Craniopharyngioma

Start date: April 10, 2023
Phase: Phase 2
Study type: Interventional

MEKTOVI (binimetinib) is an oral, highly selective reversible inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2. The biological activity of binimetinib that has been evaluated bith in vitro and in vivo in a wide variety of tumor types In this Phase II, the drug will be used to treat pediatric patients diagnosed with recurrent Adamantinomatous Craniopharyngioma including patients who have undergone surgery and/or radiation therapy.

NCT ID: NCT05286385 Completed - Clinical trials for Hearing Impairment, Sensorineural

CP1150 Sound Processor Speech Perception Compared With the Next Generation of Signal Processing Technology

Start date: May 30, 2022
Phase: N/A
Study type: Interventional

This clinical study aims to investigate speech performance in quiet with an OTE Sound Processor with modified firmware compared with the commercially available CP1150. The study also investigates CP1110 and CP1150 with Forward Focus.

NCT ID: NCT05284799 Completed - Influenza Clinical Trials

Immunogenicity and Safety of the Concomitant Administration of OVX836 and Quadrivalent Influenza Vaccine in Healthy Volunteers.

Start date: May 9, 2022
Phase: Phase 2
Study type: Interventional

The present study will evaluate the concomitant administration of a Quadrivalent Inactivated Influenza Vaccine with the highest dose level of OVX836 (480µg) tested in the clinic to date, for which the likelihood for interference with Quadrivalent Inactivated Influenza Vaccine is considered the highest.