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NCT ID: NCT06402136 Recruiting - Clinical trials for Healthy Volunteers Only

Evaluation Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of 83-0060 in Healthy Volunteers

Start date: April 15, 2024
Phase: Phase 1
Study type: Interventional

This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of 83-0060 in Healthy Volunteers

NCT ID: NCT06402123 Not yet recruiting - Clinical trials for Mitochondrial Encephalopathy, Lactic Acidosis and Stroke-Like Episodes (MELAS Syndrome)

A Phase 2b Study of Zagociguat in Patients With MELAS

PRIZM
Start date: July 15, 2024
Phase: Phase 2
Study type: Interventional

PRIZM is a Phase 2b randomized, double-blind, placebo-controlled, 3-treatment, 2-period, crossover study evaluating the efficacy and safety of oral zagociguat 15 and 30 mg vs. placebo when administered daily for 12 weeks in participants with genetically and phenotypically defined MELAS.

NCT ID: NCT06401746 Recruiting - Gastroparesis Clinical Trials

Body Surface Gastric Mapping in Patients on Semaglutide

Start date: May 1, 2024
Phase:
Study type: Observational

Glucagon-like receptor-1 agonists (GLP-1 RAs), such as Semaglutide (Ozempic), are a class of drugs used for glycemic control in diabetes, and for weight loss and management in obesity. It has been shown to delay gastric emptying and lead to gastrointestinal symptoms. However, the exact mechanisms are unknown. Alterations in gastric function, including myoelectrical activity, may be a likely mechanism of gastrointestinal side effects. Body Surface Gastric Mapping (BSGM) using the FDA-approved medical device Gastric Alimetry is a novel non-invasive diagnostic tool to assess gastric myoelectrical activity and patient-reported symptoms to achieve accurate non-invasive biomarkers of gastric dysfunction. A proof-of-principle case study of Ozempic using Gastric Alimetry showed abnormal gastric myoelectrical activity along with the development of severe bloating following the meal after 5 weeks of Ozempic use. This study will extend on this initial finding by conducting an exploratory pilot study to investigate the effects on gastric motility in patients with and without diabetes before and after Ozempic. It is hypothesized that Gastric Alimetry will show changes in gastric myoelectrical activity and symptoms in patients after being on the weekly injectable Ozempic compared to baseline.

NCT ID: NCT06401538 Not yet recruiting - Jeavons Syndrome Clinical Trials

BMB-101 in Epilepsy With Eyelid Myoclonia (EEM)

Start date: July 15, 2024
Phase: Phase 2
Study type: Interventional

The study is a pilot, open-label, study to test whether BMB-101 is safe and effective in reducing the frequency of seizures in subjects with Epilepsy with Eyelid Myoclonia (also called Jeavons Syndrome). The study will last up to 6 months. There will be a 1 month screening period, then 3 months on open-label BMB-101 including titration and tapering/washout periods, and then a 1 month follow-up period. There will be 7 clinic visits.

NCT ID: NCT06401304 Recruiting - Breast Cancer Clinical Trials

Oncologic, Cosmetic and Patient Reported Outcomes in Value-Based Breast Surgery (OnCoPRO Value)

OncoPROValue-1
Start date: January 1, 2020
Phase:
Study type: Observational

The study aspires to provide outcomes on surgery, quality of life and time-to-event outcomes following the development and validation of a standardised surgical assessment tool in a shared decision-making framework for patients with pre-invasive or invasive breast cancer with breast conservation.

NCT ID: NCT06400485 Not yet recruiting - Clinical trials for Advanced Solid Tumors

AMT-676 in Patients With Advanced Solid Tumors

Start date: June 1, 2024
Phase: Early Phase 1
Study type: Interventional

This is a first-in-human, non-randomized, open-label, multicenter Phase 1 study will evaluate the Maximum tolerated dose (MTD)/the recommended Phase 2 Dose (RP2D), safety, tolerability, anti-drug activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-676 in Patients with Advanced Solid Tumors.

NCT ID: NCT06399393 Recruiting - Multiple Myeloma Clinical Trials

A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation

KarMMa-9
Start date: October 16, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy, safety, and tolerability of ide-cel with lenalidomide (LEN) maintenance to that of LEN maintenance alone in adult participants with Newly Diagnosed Multiple Myeloma (NDMM) who have achieved a suboptimal response post autologous stem cell transplantation (ASCT).

NCT ID: NCT06399315 Recruiting - AML Clinical Trials

Study of Single and Multiple Ascending Doses of ZE46-0134 in Healthy Volunteers

Start date: July 28, 2023
Phase: Phase 1
Study type: Interventional

This is a clinical study aiming to assess pharmacokinetics and biomarker evidence of ZE46-0134 efficacy in Healthy Volunteers after single and multiple daily doses of the study drug

NCT ID: NCT06398951 Active, not recruiting - Oxygen Deficiency Clinical Trials

HFNC vs Two Nare HFNC in Extubated Patients

HFNC
Start date: July 1, 2023
Phase: N/A
Study type: Interventional

High flow nasal cannula (HFNC) are introduced to clinical practice to improve oxygenation. Our group were the first to report the use of HFNC in extubated patients that showed comparable delivery of oxygen and improved comfort. These HFNC are subsequently shown to be useful in several clinical conditions in critically ill patients including respiratory failure due to hypoxia, hypercapnia (exacerbation of chronic obstructive lung disease), or post-extubation, pre-intubation oxygenation, and others. Recently a new mode of high flow oxygen therapy has been presented on the market where the prongs of high flow have two different diameters. These two-nare size high flow nasal cannula are capable of delivering gases at a flow rate of 15-50 L/min, similar to the conventional HFNP but the difference in the diameters provide different levels of positive pressure as compared to conventional HFNP. This positive pressure could help in gas exchange of patients who need more oxygen. These devices are approved by the Therapeutic Goods Administration (TGA); the medicine and therapeutic regulatory agency of the Australian Government. Our aim is to compare the two size nare high flow nasal cannula with conventional high flow nasal cannula in extubated patients in intensive care unit in a randomised crossover trial. The comparison will include arterial blood gasses, physiological data including heart rate, respiratory rate, saturations as well as comfort and tolerance of the patients to two size nare high flow nasal cannuale.

NCT ID: NCT06395285 Not yet recruiting - ROSAH Clinical Trials

Evaluating the Safety and Tolerability of Orally Administered DF-003 in ROSAH Syndrome Patients

Start date: May 20, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety and tolerability of DF-003 in retinal dystrophy, optic nerve edema, splenomegaly, anhidrosis, and migraine headache (ROSAH) syndrome patients.