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NCT ID: NCT05731999 Completed - Drug Abuse Clinical Trials

A First Study in Healthy Volunteers of a New Mobile Phone Application Measuring the Eyes Before and After Medication

Start date: February 15, 2023
Phase: N/A
Study type: Interventional

This is a pre-market, explorative, early feasibility, pilot, controlled clinical investigation designed to collect initial clinical data on the medical device Previct Drugs.

NCT ID: NCT05731973 Recruiting - Pectus Excavatum Clinical Trials

Intercostal Nerve Cryoablation Versus Epidural Analgesia for Nuss Repair of Pectus Excavatum

ICE
Start date: December 8, 2023
Phase: N/A
Study type: Interventional

Primary objective of the current study is to determine the impact of intercostal nerve cryoablation on postoperative length of hospital stay compared to standard pain management of young pectus excavatum patients (12-24 years) treated with the minimal invasive Nuss procedure. The study is designed as a single center, prospective, unblinded, randomized clinical trial.

NCT ID: NCT05731687 Recruiting - Clinical trials for Coronary Artery Disease

Bifurcation PCI With a Hybrid Strategy With Drug Eluting Balloons Versus a Stepwise Provisional Two-stent Strategy

Hybrid DEB
Start date: March 21, 2023
Phase: N/A
Study type: Interventional

The optimal treatment of coronary bifurcation lesions is complex and remains subject of current research. There is ongoing debate about the optimal strategy for bifurcations with upfront two-stent strategy or provisional one-stent strategy. Current European Society of Cardiology (ESC) guidelines advise a provisional approach with optional stepwise two-stent strategy in case of suboptimal result of the side branch (SB). However, a two-stent strategy (either upfront and stepwise) caries technical difficulties and is associated with increased procedure duration and costs and higher exposure of the patient to radiation and contrast. Therefore there is upcoming interest in the use of a drug-eluting balloon (DEB) in the side branch of bifurcation lesions after provisional approach. Drug-eluting balloons are conventional semi-compliant angioplasty balloons covered with an anti-proliferating drug, which is released into the vessel wall during inflation. Several small pilot studies have successfully investigated a hybrid approach with use of DEB in addition to the provisional strategy. This hybrid approach has shown to be safe and feasible, however no large trials have been performed comparing this with current two-stent bifurcation strategies. The aim of this randomized controlled, single blinded, multicenter trial is to investigate whether a hybrid DEB approach is non-inferior to a stepwise provisional two-stent strategy in patients with de novo bifurcation lesions and a suboptimal result of the SB after provisional approach. Patients included in this study will receive PCI using provisional approach (implantation of drug-eluting stent (DES) in the main branch). Patients with an unsatisfactory result of the SB after provisional PCI (≥ 70% residual stenosis and/or diminished flow < Thrombolysis in Myocardial Infarction (TIMI) III) will be randomized in a 1:1 ratio to receive the Hybrid DEB approach or the two-stent strategy. Patients with a satisfactory result of the side branch after provisional PCI will be included in a registry. Follow-up will be performed at 12 months and at the anticipated median 2 year follow-up with a minimum follow-up of 1 year in each subject by either a phone call or outpatient clinic visit. During follow-up information regarding cardiovascular drug use, hospitalizations, invasive and non-invasive diagnostic tests, angina status and SAE's is obtained.

NCT ID: NCT05731622 Recruiting - Clinical trials for Upper Urinary Tract Carcinoma

Effect of a SI-MMC on the IVR Rate After Ureteroscopy for UTUC

SINCERE
Start date: February 2024
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to evaluate the intravesical recurrence (IVR) rate after ureteroscopy (diagnostic or treatment) for upper tract urothelial carcinoma (UTUC) followed by an adjuvant single instillation of Mitomycin C (SI-MMC). The main question it aims to answer are: - What is the total and time to IVR after 2 years after ureteroscopy (diagnostic or treatment) for UTUC - How is the IVR compared with a historical cohort (no SI-MMC) - What is the time to IVR after 2 years in patients who subsequently received treatment by endoscopy vs. radical nephroureterectomy (RNU) - What is the additional value of a SI-MMC on time to IVR after RNU + adjuvant MMC in patients who were evaluated by ureteroscopy prior to RNU

NCT ID: NCT05731375 Not yet recruiting - B-cell Lymphoma Clinical Trials

Mitochondrial dysfUnction: a Key Player in Doxorubicin-induced Skeletal and Cardiac muscLE Damage

MUSCLE
Start date: April 2024
Phase:
Study type: Observational

The goal of this observational study is to demonstrate the ability of using non-invasive Phosphorus (31P) Magnetic Resonance Spectroscopy (MRS) to monitor changes of in-vivo markers of mitochondrial function in skeletal and cardiac muscles in muscles in large B- or T-cell lymphoma patients during treatment with (R-)CHOP. The main question it aims to answer is: • Can 31P-MRS be used to monitor changes of in vivo markers of mitochondrial function in skeletal and cardiac muscles in large B- or T-cell lymphoma patients during treatment with (R-)CHOP? To be able to answer this main question, participants will undergo 31P-MRS imaging of the calf muscles and of the heart 3 times during the study period.

NCT ID: NCT05730933 Recruiting - Clinical trials for Eosinophilic Esophagitis

An Intervention Study to Improve Therapeutic Compliance in Adult Patients With Eosinophilic Esophagitis.

Start date: April 12, 2023
Phase: N/A
Study type: Interventional

In many chronic conditions adherence to long-term treatment is a challenge, also for patients with eosinophilic esophagitis. Interventions, such as behavioral, educational and reminder interventions might improve treatment adherence. With this trial the investigators want to assess the effects of additional education in combination with more frequent follow up and patient reminders on adherence to treatment in adult patients with eosinophilic esophagitis.

NCT ID: NCT05730634 Completed - Clinical trials for Diabetes Mellitus, Type 2

The Effect of Statin Treatment on Arterial Wall Inflammation as Assessed With 68Ga-DOTATATE PET-CT

CARAMEL
Start date: June 1, 2019
Phase: N/A
Study type: Interventional

To study the effect of atorvastatin treatment on vascular uptake of 68Ga-DOTATATE in patients with Type 2 Diabetes.

NCT ID: NCT05730036 Recruiting - Clinical trials for Relapsed Refractory Multiple Myeloma (RRMM)

A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma

LINKER-MM3
Start date: September 18, 2023
Phase: Phase 3
Study type: Interventional

This study is researching an experimental drug called linvoseltamab, also called REGN5458. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed. These participants were no longer benefiting from standard medications and had no good treatment options. In that study, some participants who were treated with linvoseltamab had improvement of their myeloma (shrinkage of their tumors), including some participants who had complete responses (that is, the treatment got rid of all evidence of myeloma in their bodies). This study is focused on participants who have multiple myeloma that has returned or needs to be treated again after one to four prior treatments and have standard cancer treatment options available to them. The aim of this study is to see how safe and effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab, pomalidomide and dexamethasone, (called EPd) in participants who have returned after having received prior treatment that included lenalidomide, a proteosome inhibitor, and (for participants in some countries) a cluster of differentiation 38 (CD38) antibody. Half of the participants in this study will get linvoseltamab, and the other half will get EPd. This study is looking at several other research questions, including: - How long participants benefit from receiving linvoseltamab compared with EPd - How many participants treated with linvoseltamab or EPd have improvement of their multiple myeloma and by how much - What side effects happen from taking linvoseltamab compared to EPd - How long participants live while receiving treatment or after treatment with linvoseltamab compared to EPd - If there is any improvement in pain after treatment with linvoseltamab compared to EPd

NCT ID: NCT05728996 Recruiting - Acute HIV Infection Clinical Trials

Netherlands Cohort Study on Acute HIV Infection

NOVA
Start date: August 1, 2015
Phase:
Study type: Observational

Investigation of the size, variability and localization of the (pro) viral reservoir and the properties of HIV-specific immune response related to "post-treatment viral remission' achievement and / or duration. In addition we will study the factors that determine latency in the different host cells, their sensitivity to induction of replication competent virus by various agents and the potential application of these agents in "post-treatment viral remission". This all will be studied in patients included during acute phase of the infection who start antiretroviral therapy immediately upon diagnosis.

NCT ID: NCT05728255 Not yet recruiting - Syncope Clinical Trials

Assessment of the Mechanism of Non-cardiac Syncope

2STEPS
Start date: April 2024
Phase:
Study type: Observational

Identifying the mechanism of non-cardiac syncope is the essential prerequisite for an effective personalized therapy. Aim of this multicentre, prospective, cross-sectional, observational study is to assess effectiveness and diagnostic yield of a two-step standardized assessment which consists of 24-hour ambulatory blood pressure monitoring (ABPM) and of tilt-table Short Cardiovascular Autonomic Function Battery (SCAFB) which consists in carotid sinus massage (CSM), limited to patients ≥40-year-old, standing test, and head-up tilt test (HUT) performed one after the other in an uninterrupted sequence as a single procedure on a tilt table