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NCT ID: NCT04968574 Completed - Clinical trials for Idiopathic Pulmonary Fibrosis

A Study Evaluating the Safety and Efficacy of ENV-101 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Start date: August 26, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2, randomized, placebo controlled, multi-center study in subjects with mild to moderate IPF. Eligible subjects will be randomized to receive placebo or ENV-101 as a daily oral dose for 12 consecutive weeks of treatment. Following treatment, subjects will be observed for an additional 6 weeks.

NCT ID: NCT04966832 Completed - Healthy Volunteers Clinical Trials

Safety, Tolerability and Pharmacokinetics of XW10508 Immediate and Modified Release Formulations in Healthy Adults

Start date: July 13, 2021
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of XW10508 in healthy volunteers.

NCT ID: NCT04966741 Completed - Clinical trials for Bardet-Biedl Syndrome

Setmelanotide in Pediatric Patients With Rare Genetic Diseases of Obesity

Start date: February 16, 2022
Phase: Phase 3
Study type: Interventional

This is a phase 3 open-label, one-arm, clinical study to evaluate the efficacy, safety and tolerability of setmelanotide over 1 year of treatment, in pediatric patients aged 2 to <6 years with obesity due to either biallelic variants of the POMC, PCSK1 or LEPR genes or Bardet-Biedl Syndrome (BBS).

NCT ID: NCT04962503 Completed - Clinical trials for Arterial Ischemic Stroke

A Proof of Concept Study to Evaluate the Safety of Afamelanotide in Patients With Acute Arterial Ischaemic Stroke (AIS)

Start date: June 3, 2021
Phase: Phase 2
Study type: Interventional

The primary study objective is to assess the safety of afamelanotide while the secondary objective is to assess whether the therapy affects the size of the penumbra, by increasing blood flow, restoring oxygen supply to the brain, and reducing the amount of cerebral oedema (fluid) which is seen as a result of the stroke. Positive findings would indicate that the drug is able to support brain tissue-at-risk and provide overall neuroprotection and benefit to stroke patients.

NCT ID: NCT04961541 Completed - Covid19 Clinical Trials

Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine

Start date: September 8, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a randomized, observer-blinded, Phase 1/2 study evaluating the safety and immunogenicity of a quadrivalent HA nanoparticle influenza and SARS-CoV-2 rS nanoparticle combination vaccine with Matrix-M1 adjuvant; this combination is referred to as ICC vaccine.

NCT ID: NCT04946188 Completed - Diabetes Type 2 Clinical Trials

Translating Biometric Data Into Blood Glucose Levels

Start date: July 21, 2020
Phase: N/A
Study type: Interventional

This study is designed to assist with the development of a first, truly non-invasive technology for blood glucose monitoring, which will have the potential to eliminate the need for painful finger pricking or expensive continuous blood glucose monitor use. The purpose of this study is to collect biometric data, such as bioimpedance (how well the body impedes electric current flow), from participants who are living with type 2 diabetes. A proof-of-concept prototype (non-invasive continuous glucose monitor; NI-CGM) will be used to collect this biometric data. The data will then be used to develop and refine a computer model that can be used to predict blood glucose levels (BGLs). Individuals with diabetes experience a great range of blood BGLs throughout their daily life and activities, therefore it is essential to gather biometric data corresponding to this large range to build a computer model, to ensure model reliability.

NCT ID: NCT04945226 Completed - Clinical trials for Androgenetic Alopecia

A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001

Start date: September 21, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001

NCT ID: NCT04944992 Completed - Clinical trials for Nonalcoholic Steatohepatitis

A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)

Start date: August 4, 2021
Phase: Phase 2
Study type: Interventional

The principal goal of this study is to determine the efficacy of efinopegdutide in liver fat reduction in participants with NAFLD. The primary hypotheses are that efinopegdutide is superior to semaglutide, or that efinopegdutide is superior to semaglutide by at least 10% with respect to mean relative reduction from baseline in liver fat content (LFC) after 24 weeks.

NCT ID: NCT04943731 Completed - Laryngectomy Clinical Trials

Day/Night Regimen With Provox Life Heat and Moisture Exchangers

Start date: July 26, 2021
Phase: N/A
Study type: Interventional

Purpose and Aim: This research is about patients who have had a total laryngectomy, trialing a new range of Heat and Moisture Exchangers (HMEs) - referred to as the "Provox Life™ range of HMEs". The main purpose of this study is to find out if participants experience any differences in the amount of coughing and mucus problems when using the new range of Provox Life™ HMEs (and attachment devices) following an optimal Day/Night regimen. The study is sponsored by Atos Medical. Study Design: Participants will use the new Provox Life™ HME range and their attachments during two (2) observation phases (Phase 1, Phase 2). In Phase 1 (6 week study phase), participants will use the new Provox Life™ HMEs in a similar way as they currently use their existing HME devices. In the Phase 2 (6 week study phase), they will use the Provox Life™ HME devices following an optimal Day/Night regimen - with the aim to achieve the best possible humidification at all times. Prior to each study phase, participants will meet with their speech pathologist to learn about the new devices and how to use them. Once comfortable using them they will commence each observation phase. Data Collection: Experiences using their existing HMEs (prior to study) and then using the new HMEs in Phase 1 and Phase 2 will be collected via a series of questionnaires. These will be completed 5 times in total - at baseline before Phase 1 starts, and then at both week 2 and week 6 of Phase 1 and 2. Questionnaires relate to their use of the HMEs, coughing and mucus problems, skin integrity, overall experiences of using the new devices and any impacts on sleep and quality of life. Participants will complete some of the questionnaires at home (approx. 30mins) and the others during an interview session with one of the study team (approx. 30mins). The interview session can be conducted via telephone, videoconferencing or in person - depending on the patients preferences and any COVID restrictions.

NCT ID: NCT04940624 Completed - Clinical trials for Dravet Syndrome (DS)

A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome

Start date: October 28, 2021
Phase: Phase 3
Study type: Interventional

The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of convulsive seizures in children and young adults with DS. Participants will receive their standard antiseizure therapy, plus either a tablet of soticlestat or placebo for 16 weeks. A placebo looks just like soticlestat but will not have any medicine in it. Participants may continue treatment in an extension study, based on the extension study's entry criteria. Those that want to stop treatment will have a gradual dose reduction during 1 week and then be followed up for 2 weeks.