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NCT ID: NCT05028348 Recruiting - Multiple Myeloma Clinical Trials

A Study of Combination of Selinexor, Pomalidomide, and Dexamethasone (SPd) Versus Elotuzumab, Pomalidomide, and Dexamethasone (EloPd) in Subject With Previously Treated Multiple Myeloma

Start date: April 19, 2022
Phase: Phase 3
Study type: Interventional

This phase 3 randomized, open-label multicenter trial will compare the efficacy, safety and the impact on health-related quality of life (HR-QoL) of SPd versus EloPd in pomalidomide-naïve patients with MM who have received 1 to 4 prior anti-MM regimens and been treated with an immunomodulatory imide drug (IMiD), proteasome inhibitor (PI) and an anti-CD38 monoclonal antibody (mAb).

NCT ID: NCT05028023 Recruiting - Tracheal Stenosis Clinical Trials

Tracheal Dilatation in Pediatric Patients With Acquired Tracheal Stenosis, and the Effects of Apneic Oxygenation

Start date: October 21, 2020
Phase: N/A
Study type: Interventional

The study presents an alternative method of tracheal dilatation in pediatric patients with acquired tracheal stenosis. Dilatation is performed by the use of balloon catheter connected with manometer, that is bronchoscopic guided into trachea in the stenotic area, through the wide canal of supraglottic device i-Gel. Every dilatation cession consists of three consequent tracheal balloon dilatations of maximum 3 minutes duration each, followed by 10-15minutes interval of controlled ventilation. The balloon is inflated for 60 seconds to reach predefined pressure, and then deflated. This method is minimal traumatic for tracheal mucosa, and application of several dilatation procedures every 2-3months, in pediatric patients with acquired tracheal stenosis, may lead to a relative reopening of trachea and recession of clinical symptoms.For the right performance of the dilatation procedure, patients receive general anesthesia with cessation of spontaneous ventilation. During procedure, controlled ventilation-oxygenation is impossible, because the i-Gel canal is occupied by bronchoscope and balloon catheter, so patients will remain apneic for a short period of time. For pediatric patients is important to perform proper preoxygenation prior to procedure, and to maintain oxygenation as long as possible during procedure. This is achieved by application of apneic oxygenation, through a small catheter, connected to high flow oxygen. Participants are exposed during first dilation to no oxygenation, while during second and third dilatation to apneic oxygenation. Aim of the study is to investigate primarily whether application of apneic oxygenation, in pediatric patients during tracheal balloon dilatation, maintains regional cerebral oxygen saturation rSO2 in significant higher levels, compared with no application of oxygenation. rSO2 levels are a sensitive index of oxygenation efficacy of the brain, accordingly this refers to a safe procedure. Secondary issues are whether application of apneic oxygenation maintains pulse oximetry SpO2 and artierial oxygen partial pressure PaO2 in higher levels, and what are the effects on arterial carbon dioxide partial pressure PaCO2 and on haemodynamic parameters (heart rate, blood pressure), compared with no application of apneic oxygenation.

NCT ID: NCT05022186 Recruiting - Clinical trials for Mild Cognitive Impairment

The Effects of Cannabidiol and Homotaurine in Patients With Mild Cognitive Impairment

Start date: April 1, 2021
Phase: Phase 4
Study type: Interventional

A Randomized Clinical Trial that will compare the effects of Cannabidiol and Homotaurine in cognition and mental health in patients with Mild Cognitive Impairment and APOE ε4 carriers. Ninety patients will be recruited and they will be randomly distributed in three groups. The first group will receive treatment with Cannabidiol 5%, the second group will receive treatment with Vivimind and the third group will not receive any treatment. The three groups will be compared by using an extensive neuropsychological examination and biomarkers' results from cerebrospinal fluid and blood

NCT ID: NCT05021887 Recruiting - Asthma Clinical Trials

A Bioequivalence Study Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100 mcg/Blister Oral Inhalation Powder /GSK in Healthy Volunteers Under Fasting Conditions

Start date: August 13, 2021
Phase: Phase 1
Study type: Interventional

Bioequivalence study between two inhaler products of ffluticasone propionate inhalation powder

NCT ID: NCT05021835 Recruiting - Inflammation Clinical Trials

ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation

ZEUS
Start date: August 30, 2021
Phase: Phase 3
Study type: Interventional

This study is conducted to see if ziltivekimab reduces the risk of having cardiovascular events (for example heart attack and stroke) in people with cardiovascular disease, chronic kidney disease and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). This is known as the study medicine. Which treatment participants get is decided by chance. Participants chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine doctors cannot prescribe. Participants will get the study medicine in a pre filled syringe. Participants will need to use the pre filled syringe to inject the study medicine into a skinfold once-monthly. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have blood and urine samples taken at most of the clinic visits. Participants will have their heart examined using sound waves (echocardiography) and electrodes (electrocardiogram). Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

NCT ID: NCT05020236 Recruiting - Multiple Myeloma Clinical Trials

MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

MAGNETISMM-5
Start date: October 4, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will compare the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone. Participants in all parts of the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.

NCT ID: NCT05015218 Recruiting - Clinical trials for Haemodynamic Instability

Internal Jugular Vein and Spinal-induced Hypotension

Start date: November 1, 2021
Phase:
Study type: Observational [Patient Registry]

The study aims to assess internal jugular vein ultrasound derived measurements and indices prior to spinal anesthesia in elderly population who fulfills predetermined inclusion criteria and might greatly benefit from an appropriate hemodynamic control during orthopedic surgery. Therefore, it is evaluated the diagnostic performance of these indices in predicting spinal-induced hypotension in this subset of participants.

NCT ID: NCT05014113 Recruiting - Osteoarthritis, Hip Clinical Trials

H-28 DELTA ST-C and Minima Retrospective Study.

Start date: September 15, 2020
Phase:
Study type: Observational

The study aims to assess the clinical and radiographic outcomes of DELTA ST-C in combination with MINIMA stem at 3 years after primary THA surgery, and to evaluate the overall survivorship of the implant.

NCT ID: NCT05003960 Recruiting - Autism Clinical Trials

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Autism

Start date: January 23, 2022
Phase: Phase 1
Study type: Interventional

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Autism

NCT ID: NCT04995276 Recruiting - Menopause Clinical Trials

PostmenopausAL heaLth And DIseAse (PALLADIA) Study

PALLADIA
Start date: October 1, 2021
Phase:
Study type: Observational

This is a prospective study of the incidence and risk factors of chronic diseases that are associated with menopause.