Clinical Trials Logo

Filter by:
NCT ID: NCT05789524 Recruiting - Hemophilia A Clinical Trials

The Efficacy and Safety of SerpinPC in Participants With Severe Hemophilia A or Moderately Severe to Severe Hemophilia B

PRESent-2
Start date: July 6, 2023
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of prophylactic SerpinPC administered subcutaneously (SC) to participants with severe hemophilia A (HemA) (with or without inhibitors) or moderately severe to severe hemophilia B (HemB) (without inhibitors) as part of the SerpinPC registrational program. This study consists of 3 parts: Part 1: dose-justification phase, Part 2: dose-confirmatory phase, Part 3: extension phase for participants who complete either Part 1 or Part 2. This adaptive design study has a randomized dose-justification component to investigate the efficacy and safety of SerpinPC as a therapeutic option, principally for participants with HemB without inhibitors. SerpinPC has a novel mechanism of action compared with marketed treatments and those that are in development.

NCT ID: NCT05789420 Completed - Smoking, Tobacco Clinical Trials

Nicotine Pharmacokinetics of THS Single Use of a Regular or a Menthol Stick Compared to CIG

Start date: February 16, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to describe the nicotine pharmacokinetic (PK) profile during and after single use of THS (Induction heating technology, with either a regular or menthol stick) compared to singular CIG smoking in healthy adult subjects. In addition, pharmacodynamic effects (subjective effects) will be evaluated to provide further insights on product acceptance and likelihood to use the THS again. Safety will be assessed throughout the study.

NCT ID: NCT05789290 Not yet recruiting - Clinical trials for Temperature Change, Body

Skin Temperature Reduction With Hilotherm Device

Start date: April 2023
Phase:
Study type: Observational

Cryotherapy after surgery is widely utilised and has numerous practical applications for post-operative rehabilitation. Previous research has suggested that during cold therapy, the skin temperature of the knee should be reduced to 10-15°C to maximise the therapeutic benefits of cooling while avoiding the risk of cold injuries such as nerve damage and frostbite. The temperature to which a cryocompression device should be set in order to achieve a skin temperature within the therapeutic range of 10-15°C is unknown. Furthermore, there is evidence to suggest that the temperature setting of the device does not equal that to which the skin is reduced. Therefore, it is not sufficient to assume that the temperature setting of a cryocompression device accurately reflects the achieved skin temperature. Modern cryotherapy devices mostly consist of some sort of cuff that can be wrapped around the knee, with a connecting tube to a central unit that supplies and circulates cold water to and from the cuff in order to cool the intended body part. The Hilotherm is one such device for use in this way, but its ability to reduce skin temperature to within the target therapeutic range is unknown. The aim of this study is to determine whether the Hilotherm device is capable of reducing skin temperature of the knee to within the 10-15℃ therapeutic range during a standard 30-minute treatment.

NCT ID: NCT05789082 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation

Krascendo 170
Start date: June 20, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of divarasib combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).

NCT ID: NCT05788536 Recruiting - Clinical trials for Congenital Hearing Loss Secondary to Biallelic Mutations of the Otoferlin Gene (OTOF)

A Study of DB-OTO, an Adeno-associated Virus (AAV) Based Gene Therapy, in Children/Infants With Hearing Loss Due to Otoferlin Mutations

CHORD
Start date: May 12, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Regeneron is conducting a study of an investigational new drug called DB-OTO. DB-OTO is a gene therapy that is being developed to treat children who have hearing loss due to changes in the otoferlin gene. The purpose of this study is to: - Learn about the safety of DB-OTO - Determine how well DB-OTO is tolerated (does not cause ongoing discomfort) - Evaluate the efficacy of DB-OTO (how well DB-OTO works)

NCT ID: NCT05787756 Recruiting - Parkinson Disease Clinical Trials

Constipation and Changes in the Gut Flora in Parkinson's Disease

GUT-PD
Start date: January 1, 2023
Phase:
Study type: Observational

The aim of this study is to investigate the link between gut health and Parkinson's disease

NCT ID: NCT05787652 Active, not recruiting - Obesity Clinical Trials

Adults Regulating Their Weight Everyday With Mobile Internet Support

ARTEMIS
Start date: March 24, 2023
Phase: N/A
Study type: Interventional

Adults Regulating Their weight Everyday with Mobile Internet Support (ARTEMIS) is a randomised controlled trial evaluating the effectiveness of a mobile app based weight loss intervention designed to increase self-regulation in adults living with obesity.

NCT ID: NCT05786716 Recruiting - Solid Tumor Clinical Trials

DETERMINE Trial Treatment Arm 04: Trastuzumab in Combination With Pertuzumab in Adult, Teenage/Young Adult and Paediatric Patients With Cancers With HER2 Amplification or Activating Mutations

DETERMINE
Start date: March 7, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This clinical trial is looking at a combination of drugs called trastuzumab and pertuzumab. This combination of drugs is approved as standard of care treatment for adult patients with metastatic breast cancer. This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Trastuzumab and pertuzumab work in patients with these types of cancers which have a molecular alteration called HER2 amplification or HER2 activating mutation. Investigators now wish to find out if it will be useful in treating patients with other cancer types which are also HER2 amplified or HER2 mutated. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future. This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.

NCT ID: NCT05786625 Recruiting - Lung Cancer Clinical Trials

Bronchoscopic Microwave Ablation of Lung Tissue

AB1MALT
Start date: May 4, 2023
Phase:
Study type: Observational

The primary purpose of this study is to evaluate the safety and feasibility of the Creo Medical MicroBlate™ Flex AB1 instrument used with the AB1 electrosurgical system in patients undergoing bronchoscopic microwave ablation of peripheral lung nodules.

NCT ID: NCT05786612 Completed - Diabetic Foot Ulcer Clinical Trials

A Clinical Investigation Comparing the Clinical Performance and Cost Effectiveness of Biatain® Silicone Compared With SoC

BISIL
Start date: January 30, 2023
Phase: N/A
Study type: Interventional

A randomised controlled investigation comparing the clinical performance and cost effectiveness of Biatain® Silicone with Standard of Care dressing including filler in chronic wounds (CP351 - BISIL Study) This study (BISIL) will compare the Biatain® Silicone dressing to commonly used wound care products (AQUACEL®EXTRATM Hydrofiber® Dressing used with Mepilex® Border). The study will recruit in total 100 adult subjects with a venous leg ulcer or a diabetic foot ulcer no deeper than 2cm. Only ulcers with a duration of at least 8 weeks but no longer than a year will be included. The study will be a randomised controlled trial where half of the participants will use Biatain® Silicone and half will use the comparator for 4 weeks. Each participant will be in the study for 4-5 weeks during which there will be a weekly visit with the study team to complete the study assessments and change the dressing. The study will run for approximately one year, starting in January 2023.