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NCT ID: NCT05797610 Recruiting - Clinical trials for Primary IgA Nephropathy

A Study to Evaluate the Efficacy and Safety of RO7434656 in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

IMAGINATION
Start date: August 8, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of RO7434656, a novel Antisense Oligonucleotide (ASO) therapy in participants with primary IgA nephropathy (IgAN) who are at high risk of progressive kidney disease despite optimized supportive care.

NCT ID: NCT05797168 Recruiting - Ovarian Cancer Clinical Trials

Phase I/IIa Study for AZD5335 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Solid Tumors

FONTANA
Start date: June 5, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This research is designed to determine if experimental treatment with Antibody-drug conjugate, AZD5335, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced tumors

NCT ID: NCT05796817 Completed - Clinical trials for Mechanical Ventilation Complication

Reducing Oxygen Consumption in Critical Care

ROCC
Start date: May 25, 2023
Phase:
Study type: Observational

In normal practice oxygen supply can be easily met with existing hospital infrastructure. COVID - 19 however results in lung damage which greatly increases the amount of oxygen patients require - as a consequence some hospitals in the UK and other countries had situations where there was not enough oxygen for their inpatients. COVID - 19 has caused many more patients to requiring assistance with their breathing using a ventilator. Due to the limited supply of sophisticated ventilators that 're-use' oxygen patients breathe out, some hospitals have used ventilators normally used by patients at home (domiciliary ventilators). Whilst these are inexpensive and commonly available, any oxygen the patient breathes out is simply released into the atmosphere. The address this problem, and in turn reduce the oxygen demand on hospital infrastructure the biomedical engineering team (BME) at the Royal Brompton Hospital, London devised a simple 3-D printed modification which captures and reuses oxygen on commonly used domiciliary ventilators. Laboratory testing found this modification can increase the oxygen given by the ventilator without increasing the oxygen consumption of the ventilator - effectively reducing oxygen demand on hospital infrastructure. This study will evaluate this modification in patients admitted to intensive care requiring assistance with their breathing. This will involve measuring oxygen levels on domiciliary ventilators (Breas Nippy 4+, ResMed Lumis 150 or Vivo 1, 2 or 3) with and without the modification and with small increases in oxygen supplied to the patient for a total study period of 2 hours.

NCT ID: NCT05796219 Completed - Breast Cancer Clinical Trials

Automated Low Dose Risk Assessment Mammography (ALDRAM)

ALDRAM
Start date: February 22, 2019
Phase: N/A
Study type: Interventional

Breast cancer (BC) is the commonest cause of death in young women. Breast screening in women aged 35-45, at increased risk due to their family history, has been shown to improve survival. However, 80% of women who develop BC do not have a family history. Numerous studies have shown that high mammographic density (MD) is one of the strongest risk factors for BC development. Full field digital mammography (FFDM) can be used to assess MD, however it is not recommended for population BC screening in those <40 years of age due to the concerns about the use of ionising radiation. Safe and accurate high throughput methods to quantify MD in young women are thus required to improve risk prediction and reduce BC mortality. This study aims to develop a low dose mammogram, with quantification of density using artificial intelligence, to facilitate high throughput risk assessment in young women. 600 women aged 30-45, previously identified as being at increased risk of BC and attending for annual mammography at The Nightingale Centre will be recruited. Participants will undergo FFDM of the right breast as usual, however, following acquisition of the craniocaudal (CC) view, the breast will remain compressed and the mammogram dose reduced by 90% to deliver a LD mammogram. This process will be repeated for the right medio-lateral oblique (MLO) view. The left breast FFDM will proceed as normal. It is estimated that each extra exposure will take 1-2 minutes only. Deep machine learning methods will be used to define the relationship between standard FFDM views and their low dose counterparts and determine which view (CC vs MLO) provides the best correlation to be taken forward to the next stage of the research.

NCT ID: NCT05795699 Recruiting - Clinical trials for Fuchs Endothelial Corneal Dystrophy

A Study to Evaluate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Participants With Fuchs Endothelial Corneal Dystrophy (FECD)

Start date: March 30, 2023
Phase: Phase 3
Study type: Interventional

A study to assess the safety and efficacy of K-321 in participants with FECD after descemetorhexis.

NCT ID: NCT05795361 Available - Hunter Syndrome Clinical Trials

Post-trial Access Program of Idursulfase-IT Along With Elaprase in Children With Hunter Syndrome

Start date: n/a
Phase:
Study type: Expanded Access

As the HGT-HIT-046 (NCT01506141) and SHP609-302 (NCT02412787) studies will be closed, this post-trial access (PTA) program provides TAK-609 to participants in these studies for whom the benefit:risk ratio of continued treatment with idursulfase-IT remains positive.

NCT ID: NCT05795322 Completed - Pain Clinical Trials

Acute Effect of Sound Healing on Pain, Fatigue and Mood

Start date: February 24, 2023
Phase:
Study type: Observational

There is evidence that sound healing improves health and well-being. However, sound healing modalities, such as tuning forks, continue to be understudied, especially among people with chronic illnesses. This study examined responses to a single session of sound healing and explored whether responses varied based on analogue pain, fatigue, and mood.

NCT ID: NCT05795309 Recruiting - Type 1 Diabetes Clinical Trials

Automated Insulin Delivery in Type 1 Diabetes Complicated by Gastroparesis

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

This is a staggered randomised controlled trial that aims to assess the impact of an automated insulin delivery (AID) system on glucose, gastrointestinal and patient-reported outcomes.

NCT ID: NCT05794906 Recruiting - Clinical trials for Biochemically Recurrent Prostate Cancer

A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies

ARASTEP
Start date: April 3, 2023
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat men at high-risk of biochemical recurrence (BCR) of prostate cancer. BCR means that in men who had prostate cancer and were treated by either surgery and/ or radiation therapy, the blood level of a specific protein called PSA rises. PSA is a marker of prostate cancer cells activity. The PSA increase means that the cancer has come back even though conventional imaging such as computed tomography (CT) scans, magnetic resonance imaging (MRI) and bone scans does not show any lesion of prostate cancer. Recently a more sensitive imaging method called prostate-specific membrane antigen [PSMA] positron emission tomography [PET]) /computed tomography [CT]) scan may identify prostate cancer lesions not detectable by conventional imaging. Men with BCR have a higher risk of their cancer spreading to other parts of the body, particularly when PSA levels raised to a certain limit within a short period of time after local therapies. Once the cancer spreads to other parts of the body, it can become even harder to treat. In men with prostate cancer, male sex hormones (also called androgens) like testosterone can help the cancer grow and spread. To reduce androgens levels in these patients, there are treatments that block androgens production in the body called androgen deprivation therapy (ADT). ADT is often used to stop prostate cancer. Another way to stop prostate cancer growth and spread is to block the action of androgen receptors on prostate cancer cells called androgen receptor inhibitors (ARIs). The new generation ARIs including darolutamide can block the action of androgens receptors and are available for the treatment of prostate cancer in addition to ADT. It is already known that men with prostate cancer benefit from these treatments. The main objective of this study is to learn if the combination of darolutamide and ADT prolongs the time that the participants live without their cancer getting worse, or to death due to any cause, compared to placebo (which is a treatment that looks like a medicine but does not have any medicine in it) and ADT given for a pre-specified duration of 24 months. To do this, the study team will measure the time from the date of treatment allocation to the finding of new cancer spread in the participants by using PSMA PET/CT, or death due to any cause. The PSMA PET/CT scans is performed using a radioactive substance called a "tracer" that specifically binds to the prostate-specific membrane antigen (PSMA) which is a protein often found in large amounts on prostate cancer cells. To avoid bias in treatment, the study participants will be randomly (by chance) allocated to one of two treatment groups. Based on the allocated treatment group, the participants will either take darolutamide plus ADT or placebo plus ADT twice daily as tablets by mouth. The study will consist of a test (screening) phase, a treatment phase and a follow-up phase. The treatment duration is pre-specified to be 24 months unless the cancer gets worse, the participants have medical problems, or they leave the study for any reason. In addition, image guided radiotherapy (IGRT) or surgery is allowed and your doctor will explain the benefits and risks of this type of therapy. During the study, the study team will: - take blood and urine samples. - measure PSA and testosterone levels in the blood samples - do physical examinations - check the participants' overall health - examine heart health using electrocardiogram (ECG) - check vital signs - check cancer status using PSMA PET/CT scans, CT, MRI and bone scans - take tumor samples (if required) - ask the participants if they have medical problems About 30 days after the participants have taken their last treatment, the study doctors and their team will check the participants' health and if their cancer worsened. The study team will continue to check this and regularly ask the participants questions about medical problems and subsequent therapies until they leave the study for any reason or until they leave the study for any reason or until the end of the study, whatever comes first.

NCT ID: NCT05794672 Terminated - Clinical trials for Healthy Subjects (Indication: Asthma)

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Elarekibep in Healthy Japanese Subjects

Start date: April 11, 2023
Phase: Phase 1
Study type: Interventional

This study will assess the safety, tolerability and pharmacokinetics (PK) of elarekibep after single and multiple doses given twice daily (BID) by inhalation or intravenous (IV) in healthy Japanese subjects compared with placebo.