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NCT ID: NCT04414475 Recruiting - Clinical trials for Multiple Myeloma, Refractory

A Study of Selinexor (Seli) + Low-dose Dexamethasone (LDD) in Penta-refractory Multiple Myeloma (MM), Seli and Bortezomib + LDD in Triple-class Refractory MM, and Seli and Pomalidomide + LDD in Relapsed Refractory MM

Start date: July 1, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the efficacy, antitumor activity, safety and tolerability of selinexor plus low-dose dexamethasone in participants with penta-refractory multiple myeloma or selinexor and bortezomib plus low-dose dexamethasone in participants with triple-class refractory multiple myeloma or selinexor and pomalidomide plus low-dose dexamethasone in participants with relapsed and/or refractory multiple myeloma.

NCT ID: NCT04414085 Completed - Retrospective Clinical Trials

The Clinical Significance of Biochemical 11 Deoxycortisol Levels

Start date: October 15, 2015
Phase:
Study type: Observational

data from charts regarding clinical characteristics and androgens levels from first to last visit were collected

NCT ID: NCT04414033 Completed - Breast Cancer Clinical Trials

Bubble: A New VR-AI Way of Treatment for Hot Flashes in Women With Breast Cancer

Start date: February 1, 2018
Phase: N/A
Study type: Interventional

This study evaluates the potential of a unique artificial intelligence-virtual reality intervention called Bubble, to reduce the number and intensity of hot flashes and their accompanying psychological symptoms in women, aged 28-55, with breast cancer. A sample of 37 women with breast cancer were selected to the study. Participants were asked to answer a survey before and after using Bubble. The treatment period was 24 days. The findings are positive and show that the use of Bubble help to reduce several psychological symptoms connected to hot flashes.

NCT ID: NCT04412434 Recruiting - Stroke, Ischemic Clinical Trials

EEG Patterns in Patients With Acute Ischemic Stroke Resulted From Large Vessels Occlusion in the Anterior Circulation

Start date: October 4, 2020
Phase: N/A
Study type: Interventional

Clinical deterioration is observing in up to forty percent of patients with acute ischemic stroke (AIS) due to large vessels occlusion. Until now, there is no automated monitoring system for early detection of neurological deterioration in such patients. As a first step to develop such system investigators suggest this study aiming to evaluate patterns of brain electrical activity registered by EEG in patients with AIS attributed to the MCA or ICA territory correlated with location and extension of ischemic lesions as determined by non-contrast CT (NCT).

NCT ID: NCT04412200 Recruiting - T1DM Clinical Trials

Efficacy of Hyperbaric Oxygen Therapy (HBOT) in New-onset Type-1 Diabetes Mellitus

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

Type 1 Diabetes Mellitus (T1DM) is caused by an autoimmune process that progressively destroys the pancreatic β-cells, and leads to dependence on multiple daily insulin subcutaneous injections according to glucose measurements and dietary restrictions, leading to short and long term complications. Current data demonstrate that even modest preservation of β-cell function and endogenous production of insulin (marked by C-peptide) may result in meaningful clinical benefits including lower rates of complications, improved metabolic control, reduced insulin injections, and improved quality of life. Objective: 1. To assess the effect of HBOT on Treg, mesanchymal stem cells, and pro-inflammatory cytokines ratio in pediatric population with new-onset T1DM Secondary 2. To assess the effect of HBOT on beta cell reserve in pediatric population with new-onset T1DM 3. To assess the effect of HBOT on glycemic control parameters including time in range, HbA1c and daily insulin dose, in the pediatric population with new-onset T1DM Study design: Randomized, controlled study of pediatric and young adults patients who have been newly diagnosed with type 1 diabetes within 12 weeks prior to randomization (4-6 weeks from screening) and express peak C-peptide ≥ 0.2 pmol/ml Subjects will be randomized to hyperbaric oxygen chamber (HBOC) group and to a non-intervention, control group. Both groups will be managed similarly by carbohydrate counting and basal bolus insulin administration, based on their interstitial glucose levels by glucose continuous glucose monitoring system (CGMS) and carbohydrate counting before meals. The intervention protocol includes 12 weeks of intensive management, and 12 weeks of follow up. During the intensive management period - for 12 weeks, the HBOC group will receive 100% oxygen at 2 ATA for 90 min with 5 min air breaks every 20 min at each session. Intensive management period includes 60 daily sessions, 5 days per week within 12 weeks, During the intensive management period - for 12 weeks, the control group will receive common practice managemnt. All will be instructed to inject insulin pre-meals according to carbs-counting, and CGMS. Insulin will be administered by subcutaneous continuous insulin infusion (SCII) or by pens with CLIPSULIN only, for accurate daily dose of insulin recording. Along the 24 weeks of the study several parameters will be assessed at pre-defined time points . 1. Immune system parameters will be assessed by blood levels of T-regulatory cells, diabetes auto-antibody and inflammatory cytokines. 2. Pancreatic β cells function will be evaluated by measurements of blood area under the curve (AUC) C-peptide, peak C-peptide, and basal proinsulin/c-peptide ratio. 3. glycemic control parameters will be evaluated by CGMS data regarding time spent in glycemic range, hypoglycemic and hyperglycemic ranges, total daily dose of insulin according to CLIPSULIN , and blood tests for glycated hemoglobin (HbA1c). 4. Microbiome changes will be assessed by stool samples. Expected significance: the study suggests a safe modality used clinically among adults and other paediatric conditions, for the possible solution of an unmet urgent medical need, studied successfully in an animal model. The study is designed to be powered to answer the question of efficacy, and in addition, addresses the mechanisms by which it may halt the progression of β cell destruction in new onset T1DM.

NCT ID: NCT04411641 Active, not recruiting - Clinical trials for Secondary Progressive Multiple Sclerosis

Nonrelapsing Secondary Progressive Multiple Sclerosis (NRSPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168)

HERCULES
Start date: September 24, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in NRSPMS Secondary Objective: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 and relevant metabolites in NRSPMS and its relationship to efficacy and safety To evaluate pharmacodynamics (PD) of SAR442168

NCT ID: NCT04411199 Recruiting - Clinical trials for Surgical Site Infection

D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)

D-PLEX312
Start date: December 6, 2020
Phase: Phase 3
Study type: Interventional

Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), Compared to a SoC Treated Control Arm, in Prevention of Post Abdominal Surgery Incisional Infection.

NCT ID: NCT04411082 Terminated - ß Thalassemia Clinical Trials

A Study of IMR-687 in Subjects With Beta Thalassemia

Start date: October 16, 2020
Phase: Phase 2
Study type: Interventional

A Study to Evaluate the Safety and Tolerability of IMR-687 in Subjects with Beta Thalassemia

NCT ID: NCT04410991 Active, not recruiting - Clinical trials for Relapsing Multiple Sclerosis

Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2)

GEMINI 2
Start date: June 11, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To assess efficacy of daily SAR442168 compared to a daily dose of 14 mg teriflunomide (Aubagio) measured by annualized adjudicated relapse rate (ARR) in participants with relapsing forms of MS Secondary Objective: To assess efficacy of SAR442168 compared to teriflunomide (Aubagio) on disability progression, MRI lesions, cognitive performance and quality of life To evaluate the safety and tolerability of daily SAR442168 To evaluate pharmacodynamics (PD) of SAR442168

NCT ID: NCT04410445 Terminated - Melanoma Clinical Trials

Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence

PIVOT-12
Start date: July 27, 2020
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to compare the efficacy of bempegaldesleukin plus nivolumab versus nivolumab in patients with completely resected Stage IIIA/B/C/D, or Stage IV cutaneous melanoma who are at high risk for recurrence.