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NCT ID: NCT04948333 Active, not recruiting - Clinical trials for Chronic Myelogenous Leukemia

Asciminib Treatment Optimization in ≥ 3rd Line CML-CP.

Start date: October 13, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to optimize the treatment of asciminib in patients with chronic myelogenous leukemia in chronic phase (CML-CP) previously treated with 2 or more Tyrosine Kinase Inhibitors (TKIs). Patients for this study will be identified based on warning criteria and resistance definition following European Leukemia Network (ELN) 2020 recommendations. In addition, the study will investigate the use of two different posologies. For this, patients will receive asciminib 40 mg (twice-daily) BID or of 80 mg (once daily) once daily (QD).

NCT ID: NCT04935879 Active, not recruiting - Sickle Cell Disease Clinical Trials

A Study to Assess the Safety and Efficacy of Inclacumab in Participants With Sickle Cell Disease Experiencing Vaso-occlusive Crises

Start date: October 26, 2021
Phase: Phase 3
Study type: Interventional

This Phase 3 study will assess the safety and efficacy of inclacumab, a P-selectin inhibitor, in reducing the frequency of vaso-occlusive crises (VOCs) in approximately 240 adult and adolescent participants (≥ 12 years of age) with sickle cell disease (SCD). Participants will be randomized to receive inclacumab or placebo.

NCT ID: NCT04927247 Terminated - Sickle Cell Disease Clinical Trials

A Study of a Single Dose of Inclacumab to Reduce Re-admission in Participants With Sickle Cell Disease and Recurrent Vaso-occlusive Crises

Start date: December 13, 2021
Phase: Phase 3
Study type: Interventional

This Phase 3 study will assess the safety and efficacy of a single dose of inclacumab, a P-selectin inhibitor, for a vaso-occlusive crisis (VOC) after an index VOC in participants with sickle cell disease (SCD). Participants will be randomized to receive either inclacumab or placebo.

NCT ID: NCT04715243 Terminated - Clinical trials for Acute Respiratory Distress Syndrome Caused by COVID-19

Comparison of High Flow Nasal Cannula (HFNC), Face-mask Non-Invasive Ventilation (NIV) & Helmet NIV in COVID-19 ARDS Patients

NIV COVID19
Start date: February 2, 2021
Phase: N/A
Study type: Interventional

Objective: To determine whether NIV delivered through helmet interface reduces intubation rate among patients with COVID-19 ARDS compared to face-mask NIV and HFNC. Design, setting & participants: Two-center randomized clinical trial of 360 patients with mild to moderate ARDS and confirmed COVID-19 requiring non-invasive ventilation between August 2020 to January 2021. The patients with respiratory rate (RR) more than 30/min or oxygen saturation (SpO2) less than 90% or PaO2/FiO2 ratio less than 300 despite standard oxygen therapy by face mask (<15 L/min) who present to Royal hospital or Sultan Qaboos University Hospital (SQUH) emergency department, medical wards or intensive care unit (ICU). Intervention: Patients will be randomly assigned (block randomization) to either face-mask NIV, HFNC or Helmet NIV. The helmet is a transparent hood that covers the entire head of the patient and has a rubber collar neck seal. Main outcome and measures: The primary outcome is the rate of endotracheal intubation at 28-days. Secondary outcomes include hospital mortality at 28 and 90 days, NIV free days, invasive ventilator free days and hospital length of stay. Expected results: We assume the failure rate of Helmet NIV to be 30%, failure rate of HFNC to be 40% and failure rate of face-mask NIV to be 50%. A sample size of 360 patients (120/group) will achieve a power of 0.90 at a significance level of 0.05. To account for 10% dropout rate, the total sample required is 396 subjects(132/group).

NCT ID: NCT04680208 Completed - Clinical trials for Postoperative Complications

Study of Direct Admission of Postoperative Patients to ICU

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

Background: This study assessed perioperative factors associated with planned and unplanned postoperative ICU admission and evaluated the outcome of the two groups. There are limited researches evaluating these factors. Hence, it is important to do an audit that assesses the perioperative factors to help creating a criteria for postoperative ICU admissions. Materials and methods: This retrospective study evaluated medical records of 68 patients above 18 years between January'2016- December'2018 that were admitted to ICU postoperatively in Sultan Qaboos University hospital in Oman. Both planned and unplanned admissions were assessed who underwent elective as well as emergency surgeries. Neurologic and cardiothoracic surgeries were excluded. Data collected included patient's demographics, social status like smoking, ASA physical status (American Society of Anesthesiologists), associated comorbidities, other perioperative factors and investigations, surgical and anesthesia details were recorded. The primary outcome studied was reasons of admission for planned versus unplanned postoperative ICU admissions. The secondary outcomes included mortality outcome and length of stay in ICU.

NCT ID: NCT04657822 Recruiting - Sickle Cell Disease Clinical Trials

Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study

Start date: June 10, 2021
Phase: Phase 4
Study type: Interventional

This is a multi-center multi-national rollover study to allow continued access to crizanlizumab for patients with sickle cell disease (SCD) who are on crizanlizumab treatment in a Novartis-sponsored study (parent study) and are benefiting from the treatment as judged by the investigator.

NCT ID: NCT04624659 Recruiting - Sickle Cell Disease Clinical Trials

A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)

Start date: March 26, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This clinical trial is a Phase 2/3 study that will evaluate the efficacy and safety of etavopivat and test how well etavopivat works compared to placebo to improve the amount of hemoglobin in the blood and to reduce the number of vaso-occlusive crises (times when the blood vessels become blocked and cause pain).

NCT ID: NCT04474314 Terminated - Sickle Cell Disease Clinical Trials

A Study of IMR-687 in Subjects With Sickle Cell Disease

Start date: August 13, 2020
Phase: Phase 2
Study type: Interventional

A Study to Evaluate the Safety and Efficacy of IMR-687 in Subjects with Sickle Cell Disease

NCT ID: NCT04441762 Completed - Acute Renal Colic Clinical Trials

Atomized Intranasal Vs Intravenous Ketorolac in Acute Renal Colic Pain Management.

Ink-Arc
Start date: December 30, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Introduction: Pain is a common reason for individuals to seek health care, especially emergency care. Ketorolac has numerous advantages over other pain medications, especially the opioids. The intranasal administration of ketorolac has been shown to be safe and effective in the treatment of postoperative pain following major abdominal surgery and post dental surgery, but there have been no studies evaluating the use of intranasal ketorolac for the treatment of acute renal colic pain in the emergency department. Methods: This is a double blinded randomized controlled trial. two hundred renal colic patients presented to the emergency department will be randomized to intervention (30 mg intranasal ketorolac) and (30mg intravenous ketorolac) case groups. Their pain before and after receiving ketorolac will be measured by visual Analog Scale (VAS pain score). Patient, attending physician and administering nurse will be blinded throughout the study. The analgesic effects will be assessed by several measures including pain relief, pain intensity difference, global pain evaluation, global assessment of analgesia, and the summed pain intensity difference. The safety will be assessed by documentation of adverse events, vital signs, and clinical assessment before and after drug administration. Aim: The aim of this study is to compare analgesic effects of intranasal Ketorolac tromethamine versus intravenous Ketorolac tromethamine in adult patients with moderate to severe renal colic. Primary Objective: Analgesic effects of Intranasal Ketorolac on the visual analog scale (VAS). Secondary Objectives: Adverse Events, the need of rescue pain medications, time to discharge and recurrent visit within 24 hours. Patient Population: Adults (from age 18 to 64 years) who presents to emergency department (ED) at Sultan Qaboos University Hospital with moderate to severe acute flank pain suggestive of renal colic (visual analog scale 7 or more). Intervention: Single dose of intranasal ketorolac 30mg. Clinical measurement: Visual Analog Scale will be assessed at 0, 30 and 60 minutes after intervention. Number and dosage of rescue medication, any reported events by patient or attending physician will be documented. Outcome: Decrease in pain measures by VAS pain score after intranasal ketorolac is given, tolerability and safety evaluation.

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.