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NCT ID: NCT04822298 Terminated - Clinical trials for Non-small Cell Lung Cancer

Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer

Start date: August 31, 2021
Phase: Phase 1
Study type: Interventional

This study aims to evaluate the safety and tolerability of AMG 160 and to evaluate the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D).

NCT ID: NCT04786236 Terminated - Heart Failure Clinical Trials

Physiological Control for Mechanical Circulatory Devices

REGALVAD
Start date: December 14, 2020
Phase: N/A
Study type: Interventional

Aim of this clinical study is to compare our newly developed control algorithms for mechanical circulatory support devices based on physiological demand with the standard manual LVAD speed operation. Specifically it shall be demonstrated that: - Suction is properly detected by the pre-trained pump flow estimation algorithm - Suction events (due to changes in physiological demand) can be reduced by control algorithms compared to continuous speed - If suction is encountered, it can be detected and cleared - The pump reacts adequately to changes in patient demand due to physical activity - Physicians pump setpoints (of requested speed for a certain heartrate) can be achieved safely.

NCT ID: NCT04785547 Terminated - Clinical trials for Minimal Residual Disease

ALL SCTped 2012 FORUM Add-on Study Blina Post HSCT

Start date: December 17, 2020
Phase: Phase 2
Study type: Interventional

An add-on phase II trial within the ALL SCTped 2012 FORUM with the primary objective to determine whether the use of Blincyto in paediatric patients with B-lineage ALL and pre- and/or post-transplant MRD could induce MRD-negativity in patients who were MRD-positive before and/or after allogeneic HSCT. The study protocol entitled "A Phase II Study of Blincyto (Blinatumomab) in Children with CD19+ B-lineage Acute Lymphoblastic Leukemia (ALL) and Minimal Residual Disease (MRD)-Positivity before or following first Allogeneic Hematopoetic Stem Cell Transplantation (HSCT) in complete remission (CR1, CR2, CR3)" was included in the ALL SCTped 2012 FORUM Protocol Appendix 1b. According to protocol, 15 mcg/m2/day of Blincyto is given in continuous intravenous infusion over a 28-day cycle. Starting day for patients who are MRD-positive before HSCT is between day +60 and day +100 and for patients who become MRD-positive post HSCT it is between day +60 and day +360 post HSCT. Patients are evaluated for response at day +28 (+4 days) (bone marrow morphology and MRD analysis - defined by PCR/FLOW-techniques) after start of Blincyto-treatment at the end of first Blincyto infusion and at regular post-TX-checks (according to FORUM: days +28, +60, +100, +180 and +360 after HSCT). The protocol was approved in 10 countries (Austria, Belgium, Czech Republic, Denmark, France, Italy, Norway, Poland, Slovakia and Spain) participating ALL SCTped 2012 FORUM study. Overall, 3 patients were treated with Blincyto (2 in Oslo and 1 in Copenhagen). However, the Investigator Initiated Research Agreement was terminated by Amgen on 26 April 2022, leading to an early termination of the study, which was approved with the last protocol amendment.

NCT ID: NCT04778397 Terminated - Clinical trials for Acute Myeloid Leukemia

Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated

ENHANCE-2
Start date: July 1, 2021
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to compare the effectiveness of the study drugs, magrolimab in combination with azacitidine, versus venetoclax in combination with azacitidine in participants with previously untreated TP53 mutant acute myeloid leukemia (AML).

NCT ID: NCT04770246 Terminated - Clinical trials for Advanced or Metastatic Solid Tumors Irrespective of Gene Alterations

TAS-117 in Patients With Advanced Solid Tumors Harboring Germline PTEN Mutations

Start date: March 31, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of TAS-117 in patients with advanced or metastatic solid tumors (excluding primary brain tumors) harboring germline PTEN inactivating mutations.

NCT ID: NCT04748393 Terminated - Clinical trials for Venous Thromboembolism

Risk, Predictors, Impact and Outcome of Anticoagulation-associated Abnormal Menstrual Bleeding

TEAM-VTE
Start date: September 1, 2018
Phase:
Study type: Observational

This study is an international, multicenter, academically sponsored, observational study, that focusses on fertile female patients with proven symptomatic deep vein thrombosis of the legs (DVT) or acute pulmonary embolism (PE). The incidence and severity of abnormal menstrual bleeding will be assessed for each menstrual period and correlated to quality of life. Causes of abnormal menstrual bleeding other than active anticoagulant treatment will be assessed. Treatment of abnormal menstrual bleeding (all within routine clinical care) will be evaluated for efficacy and safety.

NCT ID: NCT04711850 Terminated - Clinical trials for Kidney Transplant Rejection

An Long-term Follow-up Trial of Kidney Tx Patients Treated With Imlifidase or PE After an AMR

Start date: January 21, 2021
Phase:
Study type: Observational

The aim of this trial is to collect data and provide a better understanding of the long-term outcome of imlifidase treatment on active or chronic active antibody-mediated rejection (AMR) in kidney transplant recipients. This is done by collecting data during an extended follow-up period of 3 years of clinical study trial 16-HMedIdeS-12, in which patients received either imlifidase or plasma exchange (PE) as AMR treatment. Data for parameters such as kidney graft survival, patient survival, kidney function, treatment of rebound of donor specific antibodies (DSA) and anti-drug antibodies (ADAs) are collected.

NCT ID: NCT04702568 Terminated - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

A Long Term Safety Study of BCX9930 in Subjects With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Start date: December 18, 2020
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate the long-term safety of daily oral treatment with BCX9930 in subjects who have participated in a previous BCX9930 trial for PNH and showed a benefit of treatment as determined by the Investigator. The study allows continued access to BCX9930 for enrolled subjects. The study will also evaluate the long-term effectiveness and impact on quality of life and general well-being of BCX9930 treatment, and the subject's satisfaction with the medication.

NCT ID: NCT04680637 Terminated - Clinical trials for Active Systemic Lupus Erythematosus

Efficacy and Safety of Efavaleukin Alfa in Subjects With Active Systemic Lupus Erythematosus

Start date: May 6, 2021
Phase: Phase 2
Study type: Interventional

The primary objective is to evaluate the efficacy and safety of efavaleukin alfa in subjects with active systemic lupus erythematosus.

NCT ID: NCT04657393 Terminated - Apnea Clinical Trials

Ventilation in Cardiac Arrest

VICA
Start date: June 1, 2019
Phase: N/A
Study type: Interventional

Over the last decades, research in cardiopulmonary resuscitation was primarily focused on uninterrupted chest compressions to restore sufficient circulation. Ventilation during ongoing chest compressions was regarded as potentially deleterious and thus not given any major scientific focus. Current guidelines advise that ventilation be monitored by end-tidal CO2 and emphasize that hyperventilation be avoided. Recent findings from arterial blood gas analyses showed high levels of arterial pCO2, resulting in a frequent occurrence of hypercapnic acidosis, which may be caused by iatrogenic hypoventilation. Ventilation during ongoing chest compressions can be hard to achieve, as nearly every breath may be terminated by simultaneous chest compressions. In case of bag ventilation the applied tidal volumes have not yet been measured und mechanical ventilators so far were not able to ventilate during chest compressions, because pressure limit settings induced termination of inspiration. The aim of this study is to provide patients with the best possible ventilation, even under ongoing chest compressions. Patients are ventilated with a new turbine-driven ventilator (Monnal T60, Air Liquide, France), which can deliver adequate tidal volumes within a very short inspiratory phase due to the inspiratory flow of > 200l/min. Thus, in deviation from the current recommendations, the ventilation rate can be doubled to 20/min, so that inspiration coincides with cardiac massage less often. The study compares effective ventilation volumes applied by two regimes, 10 breaths/min and 20/min.