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NCT ID: NCT04666038 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

BRUIN CLL-321
Start date: March 9, 2021
Phase: Phase 3
Study type: Interventional

This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.

NCT ID: NCT04665440 Terminated - Clinical trials for Mother-Infant Interaction

Response of Preterm Infants to Multisensory Stimuli

OXYVOICE
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to measure the variation of oxytocin and cortisol levels in the saliva of premature neonates and their mother after sensorial stimuli.

NCT ID: NCT04663373 Completed - Clinical trials for Coronary Artery Disease

Prognostic Impact of Physical Activity Patterns After Percutaneous Coronary Intervention (PIPAP Study)

PIPAP
Start date: December 1, 2020
Phase:
Study type: Observational

Physical activity monitoring after coronary bypass grafting and other major surgeries has been found to be predictive for hospital readmission and adverse outcome. In patients after percutaneous coronary intervention (PCI) it has been found that a patient reported activity score is predictive of 3 year major adverse coronary event (MACE). It is not known whether physical activity shortly after discharge from PCI is predictive of one-year MACE. Early identification of patients at increased risk of MACE would facilitate the intensification of preventive strategies in these patients. Primary objective is the quantification of physical activity (daily steps) during the first two weeks after hospital discharge as a predictor for MACE at one year. Secondary objectives are: 1) Comparison between daily steps and objectively measured activity counts (divided in time spent in moderate-to-vigorous activity, light activity and sedentary activity), as well as patient reported activity; 2) Association of daily steps after one year with reaching targets for systolic blood pressure, low-density lipoprotein cholesterol (LDL-C), body mass index (BMI) and glycated haemoglobin (HbA1c); 3) Comparison of daily steps after hospital discharge and MACE between non cardiac rehabilitation (CR), conventional hospital based CR, tele-CR and modular CR participants; 4) Comparison of daily steps at one year after hospital discharge in different CR groups.

NCT ID: NCT04663126 Terminated - Melanoma Clinical Trials

Feasibility of IV Tc-99m-tilmanocept for Imaging of M2-like TAMs in Metastatic Melanoma

Tilmanocept
Start date: February 1, 2021
Phase: Early Phase 1
Study type: Interventional

This study in 20 patients is designed as a monocentric, open-label and uncontrolled, exploratory pilot study. Patients diagnosed with advanced melanoma (stage III-IV) and scheduled for anti-PD-1 immunotherapy will be recruited for this project. Patients will receive IV 250 µg Tilmanocept, labelled with 370 MBq of Tc-99m (bolus injection) according to the Navidea's protocol in our GMP certified radiopharmaceutical unit, before the first cycle of clinically scheduled immunotherapy. Scintigraphy images will be acquired dynamically from time of injection to +30 minutes. Quantitative SPECT/CT (xSPECT/CT, Siemens Symbia Intevo, Erlangen, Germany) imaging will be performed up to 1 hour p.i. to evaluate hyperaemia, and up to 3 hours p.i. to image and measure the CD206 receptor uptake. The data of the scans will be compared to immunohistochemistry results from biopsy staining for TAMs and M2-like TAMs and retrospectively with response to the immunotherapy to determine any correlation between M2-like TAMs and treatment response. For the planned retrospective comparison we will use the FDG - PET/CT data that is done after the immunotherapy as standard of care. We will analyse the lesion size and FDG - uptake in standard of care PET/CT of CD206+ and CD206 negative lesions in Tilmanocept SPECT/CT before and after immunotherapy to determine any correlation between CD206 related uptake and treatment response.

NCT ID: NCT04662255 Active, not recruiting - Clinical trials for Lymphoma, Mantle-Cell

Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

BRUIN-MCL-321
Start date: April 8, 2021
Phase: Phase 3
Study type: Interventional

This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.

NCT ID: NCT04662177 Completed - Carotid Stenosis Clinical Trials

Co-administration of Dexmedetomidine in Carotid Endarterectomy (CEA)

Start date: November 21, 2018
Phase: Phase 4
Study type: Interventional

All neurosurgical patients at the Neurosurgery University Hospital Bern who will be operated for carotid endarterectomy (CEA) are routinely operated in deep anae¬sthesia with suppression of the electrical activity of the electroencephalogram (EEG). To achieve this suppression of the EEG activity (burst suppression, BS) high effector concentrations (Cet) of Propofol doses are needed. However, a protracted infusion of large amounts of Propofol to reach a BS during the operation can lead to accumulation and a protracted wake-up phase with poorer neurological assessability. Somatosensory evoked potentials (SSEP), and trans-cranial Doppler flow velocity in the middle cerebral artery are measured to detect ischemia until the operation. The SSEPs are used to verify the functional integrity of the nervous system in combination of the EEG and both together exclude severe global ischemia during the operation. The central acting α2-agonist Dexmedetomidine could help to reduce the amount of Propofol without influencing electrophysical studies. However, no data are currently known for practical use in carotid endarterectomy with Propofol with co-administration of Dexmedetomidine in conjunction with electrophysiological studies (SSEPs and MEPs).

NCT ID: NCT04662034 Recruiting - Clinical trials for Systolic Left Ventricular Dysfunction

Performance and Safety of the Cardiac Microcurrent Therapy System

C-MIC-II
Start date: February 5, 2021
Phase: N/A
Study type: Interventional

Patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction (NYHA III - IV) despite adequate therapy according treatment guidelines of heart failure and who have a baseline left ventricular ejection fraction of ≥25% and ≤35 will receive a C-MIC System and microcurrent therapy after device implantation with optimal medical management. At the end of the study after 6 months, the C-MIC System will be turned off. The control group will receive optimal medical management without device implantation.

NCT ID: NCT04661917 Withdrawn - Clinical trials for Chronic Kidney Disease

A Trial to Learn More About How BAY2327949 Works and How Safe it is in Patients Whose Kidneys Are Damaged Due to High Blood Sugar Levels or High Blood Pressures, and With a Further Disease of the Heart or the Blood Vessels.

ASSESS-CKD
Start date: May 31, 2021
Phase: Phase 2
Study type: Interventional

In people with type 2 diabetes (T2D), the body makes insulin, but cannot use it well. This results in high blood sugar levels causing damage to the blood vessels inside the kidneys. High blood pressure is a common condition that can cause damage to the blood vessels and heart if it is untreated. High blood pressure is also known as hypertension. Patients with type 2 diabetes (T2D) or high blood pressure are at a higher risk of having chronic kidney disease (CKD). In people with CKD, the kidneys become damaged and do not work as they should. Over time, the function of the kidney declines more, and this can lead to the requirement for dialysis or kidney transplantation. Most people with CKD are also at risk of heart conditions, such as heart attack or stroke. In this trial, the researchers want to learn if BAY2327949 reduces the amount of protein in the participants' urine. Protein in the urine is one of the signs of CKD. The researchers will compare the effects of BAY2327949 to a placebo. A placebo looks like the study drug but does not have any medicine in it. BAY2327949 is assumed to increase the blood flow through the kidneys, which may slow down the worsening of the disease. The researchers will use a placebo to learn if the changes seen in the participants are due to BAY2327949 or if the results could be due to chance. This trial will include about 120 men and women over the age of 45 who have CKD. The participants will have T2D or high blood pressure, and a further disease of the heart or blood vessels. During the trial, the participants will take either BAY2327949 or a placebo once a day for 28 days. The participants will visit their trial site about 9 times during the trial, and need to provide urine samples to check the participants' CKD symptoms. At the visits, the doctors will ask them if they have any health problems. They will also take blood samples to perform laboratory assessments.

NCT ID: NCT04661761 Completed - Xerostomia Clinical Trials

Influence of Two Paraffin Wax Chewing Gums of Different Consistency on the Stimulated Saliva Flow Rate

Start date: June 17, 2020
Phase: N/A
Study type: Interventional

The study examines two different chewing gums with regard to consistency and its influence on the result of sialometry

NCT ID: NCT04659915 Completed - Clinical trials for Glucocorticoid Effect

Counteracting Deleterious Metabolic Glucocorticoid Effects With Metformin

Gluco-Met
Start date: February 25, 2021
Phase: Phase 4
Study type: Interventional

Supraphysiological doses of glucocorticoids (GCs) are widely prescribed as immunosuppressants and metabolic side effects such as obesity and diabetes are extremely common. Efforts to investigate and prevent these side effects are lacking. The antidiabetic drug metformin was shown in previous studies to prevent deterioration of glucose homeostasis during GC therapy in patients. However, mechanisms of metformin counteracting GC-induced side effects remain poorly understood. In a randomized, placebo-controlled, cross-over study, 18 healthy volunteers will receive a 7-day course of prednisone with metformin or placebo. Established methods will be used to assess systemic changes in energy homeostasis and novel techniques such as metabolomics will identify underlying pathways. This will advance the understanding of energy homeostasis during GC excess, may prevent thousands of patients from GC-induced side effects and also offers a model for targeting disrupted endogenous GCs secretion.