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NCT ID: NCT05280275 Recruiting - Multiple Myeloma Clinical Trials

A Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin in Combination With Daratumumab, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Transplant Ineligible

Start date: April 13, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase 1/2, open label, study designed to assess the safety and clinical activity of different belantamab mafodotin doses in combination with daratumumab, lenalidomide and dexamethasone. The study will evaluate different doses of belantamab mafodotin in combination with daratumumab, lenalidomide and dexamethasone in 2 cohorts and will determine the recommended phase 2 dose (RP2D) to be further evaluated for safety and clinical activity in the dose expansion cohort. The RP2D dose will be used for future studies in the transplant ineligible newly diagnosed multiple myeloma setting. Overall, approximately 36 participants will be enrolled in the study. Participant follow-up will continue up to 3 years after the last participant is randomized. The estimated accrual period will be 12 months corresponding to an approximate total study duration of 4 years.

NCT ID: NCT05294016 Recruiting - Breast Cancer Clinical Trials

Smart Bra for Diagnosing Breast Cancer

CBRA
Start date: April 13, 2022
Phase: N/A
Study type: Interventional

This project aims to assess the ability of a portable and connected medical device to detect breast abnormalities, for breast cancer screening. It will accelerate technological progress in the face of breast cancer.

NCT ID: NCT05348798 Recruiting - Exercise Addiction Clinical Trials

Personality Traits and Exercise Addiction in Ultra Endurance Athletes

Start date: April 13, 2022
Phase:
Study type: Observational

Ultra endurance sports (events exceeding 6 hours) is becoming increasingly popular and Exercise Addiction (EA) is frequent in this type of sports, which are characterized by very high training volume. However, little is known about the personality traits of athletes who are more likely to develop EA. This study aims to assess the personality traits associated with EA in ultra endurance athletes. We designed a cross sectional study. Participants have to fill a web-based questionnaire including the Big Five Personality Test for assessing the personality traits and the Exercise Dependence Scale-Revised (EDS-R) for assessing EA. Also they have to fill a personal question about demographics (age, gender, work), sport practice and eating habits. A minimum sample size of 300 participants is expected. Statistical analyses will test the association between personality traits and the presence (or absence) of EA according to the EDS-R. Secondary analysis will test the association between the type of sport (running, cycling, triathlon, swimming), the volume of sport practice and the presence of eating disorders and EA.

NCT ID: NCT05356741 Recruiting - Clinical trials for Locally Advanced or Metastatic HER2-Expressing Cancers

To Access the Safety and Effects of Intravenous Administration of AMX-818 Alone and in Combination With Pembrolizumab in Adult Participants With Locally Advanced or Metastatic HER2-Expressing Cancers

Start date: April 13, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This first-in-human (FIH) Phase 1 open-label multicenter dose-escalation and dose-expansion study is designed to evaluate the safety, pharmacokinetics, and preliminary activity of AMX-818 as a single agent and in combination with pembrolizumab in participants with HER2+ tumors across multiple tumor types. The study will be conducted in four parts: - Part 1 (dose escalation): Single-agent AMX-818 - Part 2 (dose escalation): AMX-818 plus pembrolizumab - Part 3 (dose expansion): Single-agent AMX-818 - Part 4 (dose expansion): AMX-818 plus pembrolizumab The total length of the study, from screening of the first participant to the end of the study, is expected to be approximately 52 months.

NCT ID: NCT05380544 Recruiting - Diabetic Foot Clinical Trials

Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers

SOLEFUL1
Start date: April 13, 2022
Phase: N/A
Study type: Interventional

Summary of the problem: Diabetes has been described as the fastest growing health crisis of our time. It currently affects more than 4.5million people in the UK. The direct cost to the NHS is already over £1 billion per year. One of the commonest complications of diabetes are foot ulcers. Despite current best treatment, these ulcers can be very difficult to heal, often taking months to heal and some never do. Even after healing ulcers return in up to 60% of people. In England someone undergoes an amputation of part of their foot every 2 hours and every 4 hours someone loses their leg due to diabetic foot ulcers. People are rarely able to be as active as before. This seriously affects their work, finances and quality of life. Research into improved treatments are a national priority. These treatments need to be safe, effective, tolerable for patients and value for money. Preliminary research has identified shockwave therapy as a promising new treatment in which high-power soundwaves (similar to ultrasound) are delivered to the ulcer. This may make ulcers heal faster. However, the effectiveness of shockwave therapy and the optimum dose is unknown. The aim of the study: 1. To carry out a preliminary (pilot) trial comparing sham (not active) shockwaves, low number of shockwaves and high number of shockwaves on diabetic foot ulcer healing 2. To understand beliefs, concerns, ideas and experience of shockwave therapy amongst patients and clinicians 3. To investigate the cost effectiveness (value for money) of shockwave therapy Methods 1. Pilot Trial: Ninety patients with DFU will be randomly assigned to one of three treatment groups: 1. High dose shockwave treatment 2. Low dose shockwave treatment 3. "Sham" shockwave treatment Each treatment will be delivered in 3x30minute sessions in a 7-day period. Face-to-face follow up appointments will take place 1, 2, 3 and 6 months after treatment to measure ulcer healing and changes in quality-of-life. Interviews Interviews to explore patient opinion of shockwave therapy, experience in taking part in the trial, reasons patients do not want to take part and clinician attitudes to shockwave therapy

NCT ID: NCT05393180 Recruiting - Clinical trials for Chronic Atrial Fibrillation

CONVERGE Post-Approval Study (PAS)

Start date: April 13, 2022
Phase: N/A
Study type: Interventional

The primary objective of CONVERGE PAS is to evaluate clinical outcomes (peri-procedural and long-term) in a cohort of patients treated during commercial use of the EPi-Sense® Guided Coagulation System or EPi-Sense STâ„¢ Coagulation System to treat symptomatic long-standing persistent atrial fibrillation (AF) patients who are refractory or intolerant to at least one Class I and/or III AAD.

NCT ID: NCT05401175 Recruiting - Cervical Cancer Clinical Trials

Hematopoietic Stem Cell-containing Autologous Blood Transfusion for Bone Marrow Protection in Patients With Cervical Cancer

Start date: April 13, 2022
Phase: N/A
Study type: Interventional

The aim of this project is to promote the reconstruction of haematopoietic function after chemoradiotherapy for cervical cancer with the innovative use of autologous haematopoietic containing stem cell blood transfusion support.To explore the effect of stored hemopoietic stem cell support therapy on bone marrow protection after concurrent chemoradiotherapy, in order to promote its clinical application.

NCT ID: NCT05439057 Recruiting - Clinical trials for Postoperative Nausea and Vomiting

Effect of Remimazolam on Postoperative Nausea and Vomiting

Start date: April 13, 2022
Phase: N/A
Study type: Interventional

The present trial is to study the effect of low dose remimazolam on postoperative nausea and vomiting (PONV) in patients at risks of PONV (women, postoperative use of opioid, nonsmokers) undergoing laparoscopic cholecystectomy.

NCT ID: NCT05629598 Recruiting - Renal Anemia Clinical Trials

A Study of PEG-EPO Injection (CHO Cells) for Maintenance Therapy of Patients With Renal Anemia .

Start date: April 13, 2022
Phase: Phase 2
Study type: Interventional

The purpose of the study is to explore the optimal dose and administration of the experimental drug, and to evaluate the safety and efficacy of the drug in patients with renal anemia. Patients with renal anemia on regular dialysis treatment are expected to be enrolled in this study.

NCT ID: NCT05686616 Recruiting - Clinical trials for Tricuspid Regurgitation

SGLT2 Inhibitor for Severe Tricuspid Regurgitation

Reduction-TR
Start date: April 13, 2022
Phase: N/A
Study type: Interventional

The purpose of this study to identify the efficacy of sodium glucose cotransporter 2 inhibitors add-on treatment on right ventricular remodeling and the amount of severe tricuspid regurgitation (TR) in patients with isolated severe TR.