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NCT ID: NCT04268875 Completed - In-stent Restenosis Clinical Trials

Morphological Parameters of In-stent RESTenosis Assessed and Identified by OCT

RESTO
Start date: December 11, 2019
Phase: N/A
Study type: Interventional

The statistical risk of intrastent stenosis has fallen considerably with the emergence of latest generation coated stents (drug-eluting stents: DES). The number and clinical lifespan of stents implanted over the last twenty-five years, however, explain the fact that restenosis remains a not unusual clinical problem which is expressed as a recurrence of angina or of an acute coronary syndrome (ACS). The mechanisms involved in this restenosis are multifactorial in nature and differ depending on the type of stent and the time since the restenosis occurred. In symptomatic stent restenosis (angina or acute coronary syndrome), a further angioplasty is usually required, occasionally on an emergency basis. Coronary angiography is often not capable of explaining the mechanical causes of this complication. Optical coherence tomography (OCT), a high-resolution endocoronary imaging technique can assist in the understanding of the mechanism of restenosis and guide treatment. OCT during angiography provides a detailed analysis of the stents and potential complications: the presence of neoatherosclerosis with or without plaque rupture, intimal hyperplasia, stent under-deployment, stent fracture and distal or proximal progression of the atherosclerosis. The investigators propose a prospective, multicentre study of all cases of intrastent restenosis, examined by angiography, causing clinical features involving stable angina and acute coronary syndrome. The coronary artery involved will be routinely studied by OCT for a mechanical cause of the intrastent restenosis. The routine use of intrastent OCT may assist in the understanding of causes of restenosis and in the decision on appropriate treatment. There are several possible treatments for restenosis, including balloon angioplasty, coated balloon angioplasty, stenting or aorto-coronary bypass graft surgery.

NCT ID: NCT04268823 Terminated - Clinical trials for Chronic Obstructive Pulmonary Disease

Clinical Study to Assess the Mode of Action of QBW251 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Start date: September 10, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine whether potentiating the cystic fibrosis transmembrane conductance regulator (CFTR) with QBW251 in subjects with COPD would be efficacious with regards to reducing lung and systemic inflammation and bacterial colonization as potential drivers of airway obstruction, airway destruction, remodeling and exacerbations. Furthermore, this study provided supportive data to investigate the relationship of COPD phenotype and the response in small airway structure, function, mucus load and spirometry indices as well as in improvement of overall COPD symptoms and quality of life.

NCT ID: NCT04267783 Completed - Clinical trials for Postpartum Hemorrhage

Prediction of Uterine Atony After Vaginal Delivery by Elastography

Start date: May 1, 2019
Phase:
Study type: Observational

Prospective study evaluating the feasibility of shear-wave elastography of the uterus during the third stage of labour and following placental delivery. The investigators hypothesize that the stiffness of the myometrium can be measured by using shear-wave technology. This study involves 30 patients with a healthy pregnancy and spontaneous vaginal delivery. One co-investigator will carry out measurements at the uterine fundus, at three different time points: after fetal delivery, after placental delivery and 30 minutes after placental delivery.

NCT ID: NCT04267393 Terminated - Clinical trials for Nonalcoholic Steatohepatitis (NASH)

Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)

Start date: March 17, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH).

NCT ID: NCT04266977 Recruiting - Glioblastoma Clinical Trials

Restrictive Use of Dexamethasone in Glioblastoma

RESDEX
Start date: May 8, 2020
Phase: N/A
Study type: Interventional

The administration of steroids, most commonly dexamethasone (DEX), has established as standard of care during treatment of glioblastoma (GBM) and is widely used during the entire course of the disease including pre- and postoperative management, chemo- and radiotherapy. The primary purpose is to reduce tumor-associated vasogenic edema and to prevent or treat increased intracranial pressure. However, steroids are also linked to a multitude of adverse side effects that may affect survival of GBM patients such as major immunosuppression. The use of steroids during radiotherapy is associated with reduced overall- and progression-free survival and has been identified as an independent poor prognostic factor. Despite these findings, the suspicion of GBM often triggers the administration of DEX in routine clinical practice, regardless of neurological symptoms, tumor size, or extension of cerebral edema. The purpose of this study is to assess whether selected GBM patients can be treated safely with a restrictive DEX regimen from referral to the neurosurgical center until discharge. The primary objective is to determine the failure rate of a restrictive DEX regimen defined as edema or mass effect leading to any of the following: GCS deterioration ≥ 2 points, NIHSS increase ≥ 3 points, increase of midline Shift ≥ 2mm, or any surgical rescue procedure for increasing mass effect.

NCT ID: NCT04266301 Active, not recruiting - Clinical trials for Myelodysplastic Syndromes

Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

STIMULUS-MDS2
Start date: April 14, 2013
Phase: Phase 3
Study type: Interventional

This is a Phase III multi-center, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to azacitidine in adult subjects with intermediate, high or very high-risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) who are not eligible for intensive chemotherapy or hematopoietic stem cell transplantation (HSCT) according to medical judgment by the investigator. The purpose of the current study is to assess clinical effects of MBG453 in combination with azacitidine in adult subjects with IPSS-R intermediate, high, very high risk MDS and CMML-2.

NCT ID: NCT04265118 Completed - Sleep Apnea Clinical Trials

Sideward Turning Beds for Sleep Apnea

Start date: March 10, 2020
Phase: N/A
Study type: Interventional

The aim of this feasibility study is to compare different settings of a custom-made automated bed with respect to their ability to induce a change in the sleeping position of the user. In particular, it is of interest whether the bed mechanism is able to change the position of a user from supine to lateral position. At the same time, the investigators want to know whether the intervention provided by the bed results in an arousal in sleeping users. In addition, feasibility of detecting the position of the user using the un-obtrusive pressure sensors, which are integrated in the bed, will be assessed. Within the experiment, the investigators will identify participants that are sleeping mainly in supine position by doing an acti-watch based screening measurement in their home setting. Those participants who are sleeping in supine position for more than 12.5% of the home recording with the acti-watch will be invited to come to the lab for one night measurement. The experimenter will trigger interventions of the bed manually when the participant is lying in supine position. The investigators will evaluate the position change using infrared cameras and the built in sensors of the bed. Furthermore, a commercially available home-measurement device to record polysomnography will be used to evaluate whether the intervention caused arousals.

NCT ID: NCT04264806 Withdrawn - Clinical trials for Myelodysplastic Syndromes

A Study of Cusatuzumab in Combination With Azacitidine Compared With Azacitidine Alone in Patients With Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and Who Are Not Candidates for Hematopoietic Stem Cell Transplantation (HSCT)

Start date: May 6, 2021
Phase: Phase 2
Study type: Interventional

The purpose of the study is to compare overall response rate (ORR) between treatment groups in participants with higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) who are not eligible for Hematopoietic Stem Cell Transplantation (HSCT).

NCT ID: NCT04263649 Completed - Clinical trials for Peripherally Inserted Central Catheter

Prospective Observational Study of the Power PICC Family of Devices and Accessories

Start date: June 18, 2020
Phase:
Study type: Observational

Post-market, observational study to collect prospective data related to the safety and performance of the Power PICC family of devices and its accessories in a real-world setting.

NCT ID: NCT04263038 Recruiting - Clinical trials for Cardiovascular Diseases

Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism

SAFE-SSPE
Start date: May 15, 2020
Phase: Phase 4
Study type: Interventional

The clinical significance of pulmonary embolism (PE) limited to the subsegmental pulmonary arteries, so called isolated subsegmental pulmonary embolism (SSPE), remains controversial. Whether isolated SSPE represents "true" PE, a clinically more benign form of PE, a physiologic lung clearing process, or a false positive result (artifact) is currently unclear and hence, whether patients with isolated SSPE benefit from anticoagulant treatment is uncertain. Despite growing evidence from observational studies that withholding anticoagulation may be a safe option in selected patients with isolated SSPE (i.e., those without concomitant deep vein thrombosis, cancer, etc.), most patients with isolated SSPE receive anticoagulant treatment, which is associated with an increased risk of bleeding. The overall objective of the randomized controlled SAFE-SSPE trial is to evaluate the efficacy and safety of clinical surveillance without anticoagulation compared to anticoagulation treatment in low-risk patients with isolated SSPE.