Clinical Trials Logo

Filter by:
NCT ID: NCT04428151 Recruiting - Clinical trials for Squamous Cell Carcinoma of Head and Neck

Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)

Start date: August 6, 2020
Phase: Phase 2
Study type: Interventional

This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review.

NCT ID: NCT04420884 Recruiting - Solid Neoplasms Clinical Trials

A Study of Dazostinag as Single Agent and Dazostinag in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors

iintune-1
Start date: July 22, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The main aim of this study is to check if people with advanced solid tumors have side effects from dazostinag, and to check how much dazostinag they can receive without getting significant side effects from it when given alone and in combination with pembrolizumab. The study will be conducted in two phases including a dose escalation phase and a dose expansion phase. In the dose escalation phase, escalating doses of dazostinag are being tested alone and in combination with pembrolizumab to treat participants who have advanced or metastatic solid tumors. In the dose expansion phase, dazostinag will be studied with pembrolizumab with or without chemotherapy in participants with untreated metastatic or recurrent, unresectable squamous cell carcinoma of head and neck (SCCHN) and in combination with pembrolizumab in third-line or later recurrent locally advanced or metastatic microsatellite instability-high/mismatch repair deficient (MSI-H/dMMR) and third-line recurrent locally advanced or metastatic microsatellite stable/mismatch repair proficient (MSS/pMMR) colorectal cancer (CRC).

NCT ID: NCT04419649 Recruiting - Clinical trials for Myelodysplastic Syndromes

A Study of KER-050 to Treat Anemia Due to Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes

Start date: August 19, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effects of KER-050 on anemia in patients with very low, low or intermediate risk MDS.

NCT ID: NCT04418804 Recruiting - Pleural Effusion Clinical Trials

Diagnosis and Classification of Pleural Diseases Using Ultrasound Channel Data

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

Background: The Pleura is a double-layered membrane that surrounds the lungs. Pathological processes that involve the Pleura are called "Pleural diseases". Among them are included Pneumothorax (Air the chest cavity), Pleural effusions, and tumor formation. Ultrasound imaging of the Pleura to detect and assess pleural diseases has been proven as an excellent diagnostic and safe option. Ultrasound test uses sound waves to characterize the structure and function of different organs in health and disease. The standard technique used to create two-dimensional ultrasound picture is called Delay and Sum (DAS). Signals are transmitted and received from a series of elements and allow a two dimensional picture to be created. Because a large number of sensors is required, creating a two dimensional picture creates a large and usually redundant data pool. This fact leads to a need for stronger processors and larger operating systems, Consumption of higher energy, and hence an ungainly, slow, and expensive system. Signal Acquisition Modeling and Processing Laboratory (SAMPLE) in Weizmann institute has developed a data processing system that allows narrowing down the number of elements needed to process the ultrasound signal, while creating an ultrasound picture of abdominal organs in a satisfying resolution. Sometimes even better than standard methods. Research goal: Improvement of diagnosis and characterization of pleural diseases by Ultrasound, using a novel algorithm that was developed in SAMPLE laboratory in Weizmann Institute. The aim is to create a faster, more reliable ultrasound imaging while minimizing sampling rate and data volume. Methods: Tested population: Women and/or men who were diagnosed with Pneumothorax or Plural effusion with other imaging modalities, and healthy volunteers as a control group, Up to 30 participants per each group (Total up to 90), in a 1:1:1 Ratio. Research type: An open-labeled study. Experimental design: Participants that will meet the required conditions will be summoned to an exam in our imaging institute or will be scanned bedside, using the Verasonics ultrasound system, which allows free access to ultrasound raw Channel data. The information acquired, as well as other imaging scans of the participant, will be coded and delivered anonymously to SAMPLE laboratory for analysis.

NCT ID: NCT04417465 Recruiting - Clinical trials for Advanced Solid Tumors Cancer

First In Human Study With ABBV-CLS-579 When Given Alone and In Combination In Participants With Locally Advanced Or Metastatic Tumors

Start date: June 3, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to see how safe and effective ABBV-CLS-579 is when used alone and in combination with a PD-1 target agent or with a VEGF TKI. ABBV-CLS-579 is an investigational drug being developed for the treatment of tumors. The trial aims to establish a safe, tolerable, and efficacious dose of ABBV-CLS-579 as monotherapy and in combination. The study will be conducted in three parts. Part 1 Monotherapy Dose Escalation, Part 2 Combination Dose Escalation, and Part 3 Combination Dose Expansion. Part 1, ABBV-CLS-579 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors. Part 2, ABBV-CLS-579 will be administered at escalating dose levels in combination with a PD-1 targeting agent to eligible subjects who have advanced solid tumors. Part 3, ABBV-CLS-579 will be administered at the determined recommended dose in combination with a PD-1 target agent or with a VEGFR TKI in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC). Adult participants with a diagnosis of some solid tumors for which no effective standard therapy exists or has failed will be enrolled. Participants will receive study treatment until disease progresses or discontinued. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

NCT ID: NCT04416217 Recruiting - Clinical trials for Eosinophilic Esophagitis

Eosinophilic Esophagitis Steroid Safety Study

EESY
Start date: October 7, 2019
Phase:
Study type: Observational

This observational study will follow pediatric patients with eosinophilic esophagitis who are scheduled to begin topical steroid treatment, from the initiation of treatment longitudinally to determine the safety profile of the drug.

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: 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: 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.