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NCT ID: NCT04521686 Active, not recruiting - Glioma Clinical Trials

Study of LY3410738 Administered to Patients With Advanced Solid Tumors With IDH1 or IDH2 Mutations

Start date: October 16, 2020
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter Phase 1 study to evaluate safety, tolerability and preliminary efficacy of oral LY3410738 in patients with isocitrate dehydrogenase 1 (IDH1) arginine 132 (R132)-mutant advanced solid tumors, including but not limited to cholangiocarcinoma, chondrosarcoma, and glioma or isocitrate dehydrogenase 2 (IDH2) arginine 140 (R140) or arginine 172 (R172) mutant cholangiocarcinoma.

NCT ID: NCT04521621 Terminated - Neoplasm Metastasis Clinical Trials

A Study of Gebasaxturev (V937) in Combination With Pembrolizumab (MK-3475) in Participants With Advanced/Metastatic Solid Tumors (V937-013)

Start date: October 28, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and efficacy in participants with advanced/metastatic or recurrent malignancies who receive gebasaxturev (V937) in combination with pembrolizumab (MK-3475). The primary objective for Part 1 is to evaluate the objective response rate, and the primary objective for Part 2 is to determine the safety and tolerability of gebasaxturev administered in combination with pembrolizumab. With Amendment 4, this study will be terminated once all participants who have completed or discontinued gebasaxturev treatment and are only receiving pembrolizumab may be enrolled in a pembrolizumab extension study, if available, to continue pembrolizumab monotherapy for up to 35 cycles from first pembrolizumab dose on V937-013.

NCT ID: NCT04521478 Completed - Clinical trials for Depressive Disorder, Major

A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression

Start date: November 20, 2020
Phase: Phase 2
Study type: Interventional

This study is open to adults with depression (major depressive disorder) for whom standard treatment with antidepressants alone does not work sufficiently. The purpose of the trial is to find out whether a medicine called BI 1358894 helps to improve symptoms of depression. Four different doses of BI 1358894 are tested in the study. Participants continue their standard antidepressant therapy throughout the study. Participants are put into 6 groups by chance. Participants in 4 of the 6 groups take different doses of BI 1358894, and placebo. Participants in the fifth group take quetiapine, a medicine already used to treat depression, and placebo. Participants in the sixth group take placebo only. Participants take BI 1358894, quetiapine, or placebo as tablets. Placebo tablets look like BI 1358894 or quetiapine tablets but do not contain any medicine. Each participant takes tablets twice a day. Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 2 phone calls. At the visits, doctors ask participants about their symptoms. The results between the BI 1358894 groups, the quetiapine group, and the placebo group are then compared. The doctors also regularly check the general health of the participants.

NCT ID: NCT04521361 Active, not recruiting - Clinical trials for Bone Metastatic Castration-resistant Prostate Cancer

A Study to Assess How Radium-223 Distributes in the Body of Patients With Prostate Cancer Which Spread to the Bones

Start date: November 16, 2020
Phase: Phase 1
Study type: Interventional

In this study researcher want to gain more information on how the study drug (radium-223) is distributed in the bone, particularly in the tumor free bone in participants with prostate cancer. The study plans to enroll 60 patients with the age of at least 18 years and suffering from prostate cancer which has spread to the bones. Researcher will divide the study participants into 2 groups. Patients in Group 1 should have up to 6 bone metastases and patients for group 2 should have more than 6 bone metastases. The study medication will be given as injection into a vein every 4 weeks up to a maximum of 6 times. To study how radium distributes in the body and particularly in the bones, participants will undergo after study medication intake MRI or CT Scans (imaging techniques).

NCT ID: NCT04521231 Recruiting - Clinical trials for B Cell Precursor Acute Lymphoblastic Leukemia

A Study of Subcutaneous Blinatumomab Administration in Acute Lymphoblastic Leukemia (ALL) Patients

Start date: January 4, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The study aims to evaluate the safety, efficacy, and tolerability of subcutaneous (SC) blinatumomab for treatment of Acute Lymphoblastic Leukemia (ALL), to determine the maximum tolerated dose (MTD), and recommended phase 2 dose(s) (RP2D) of SC administered blinatumomab. It will also conduct a clinical PK evaluation of SC1 and SC2 blinatumomab formulations.

NCT ID: NCT04520932 Recruiting - Clinical trials for Neuroendocrine Tumor Grade 1

Pancreatic Radiofrequency Under High Echo-endoscopy in the Management of Pancreatic Neuroendocrine Tumors

RFANET
Start date: March 30, 2021
Phase: N/A
Study type: Interventional

Pancreatic radiofrequency ablation (RFA) could therefore be an alternative to the monitoring of pancreatic neuroendocrine tumors (PNETs) and more particularly nonfunctioning PNETs (NF-PNETs), which is costly and anxiety-inducing for patients. To date, only a few small studies have evaluated this treatment and the results are encouraging. It appears necessary to consider a large-scale study to ensure the efficacy and low morbidity of pancreatic RFA applied to PNETs.

NCT ID: NCT04520815 Recruiting - Clinical trials for Respiratory Distress Syndrome, Adult

Prevalence and Kinetics of Diaphragmatic Dysfunction in Elderly Patients With Acute Respiratory Distress

OLDIA
Start date: June 24, 2020
Phase:
Study type: Observational

Acute respiratory distress (ARD) is one of the most frequent reasons for consultation and hospitalization in emergency medicine. The use of ultrasound methods as a diagnostic and clinical assessment tool in emergency medicine is increasingly important. As such, ultrasound is a simple, non-invasive means of assessing diaphragmatic function in the patient's bed. Several methods of ultrasound assessment of diaphragm function have been described. Among these different methods, the diaphragmatic excursion seems to have a better intra and interobserver reproducibility as well as a greater feasibility, in particular because of its speed of realization and its learning curve seeming faster in comparison with the measurement. of the thickening fraction. Measuring the diaphragmatic excursion could therefore ultimately represent a simple means of assessing respiratory function, both diagnostic and prognostic, in patients with acute respiratory distress in the emergency departments. The etiologies of acute respiratory distress in very elderly patients (i.e.> 75 years) admitted to the emergency reception service are multiple. To our knowledge, there is no data available in the literature on the prevalence of diaphragmatic dysfunction and its short- and long-term course in this category of patients. The main objective of this study is therefore to assess the prevalence of diaphragmatic dysfunction and its evolutionary kinetics in patients over the age of 75 admitted for acute respiratory distress in the emergency medicine department.

NCT ID: NCT04520633 Completed - Asthma Clinical Trials

Validity of a French Version of the Severe Asthma Questionnaire

TRAQUE
Start date: November 17, 2020
Phase:
Study type: Observational

"Severe asthma affects only 5% of asthmatics, but has a considerable impact on patients owing to the respiratory disability linked to asthma but also complications from oral corticosteroid (OCS) therapy. Biologics have recently been made available, and improve quality of life (QoL)severe asthma patients. Having a reproducible and reliable measuring tool of QoL for severe asthmatics would be useful for assessing the impact of the various interventions proposed. QoL questionnaires currently used in respiratory diseases are not specific to severe asthma. They are very focused on respiratory disability, but for example do not take into account the impact of treatments, especially oral steroids. The Severe Asthma Questionnaire (SAQ) is the very first tool specifically designed to assess the health related quality of life of severe asthma population. The development of its use goes through the validation of this questionnaire in its French translation available since September 2019. "

NCT ID: NCT04520620 Withdrawn - Sars-CoV2 Clinical Trials

Concentration-effect Relationship of Enoxaparin for Thromboembolic Prevention

COV-ENOX
Start date: May 2, 2020
Phase: Phase 4
Study type: Interventional

Patients with COVID-19 have special demographic characteristics including thromboembolic risk factors . The pharmacokinetics of enoxaparin administered subcutaneously in the intensive care unit patient are not described. Finally, given the lack of knowledge on the pharmacokinetic/pharmacodynamic properties of enoxaparin in intensive care unit patients infected with SARS-CoV-2, we propose to conduct a prospective multicenter cohort study to collect the biological data necessary for its study.

NCT ID: NCT04520516 Active, not recruiting - Osteoarthritis Clinical Trials

Auricular Vagus Nerve Stimulation in Painful and Inflammatory Erosive Hand Osteoarthritis

ESTIVAL
Start date: April 8, 2021
Phase: N/A
Study type: Interventional

Erosive hand osteoarthritis (EHOA) is a difficult-to-treat subtype of HOA characterized by local and systemic low-grade inflammation as well as by high level of pain and of disability. Auricular transcutaneous vagus nerve stimulation (tVNS) is a promising therapeutic strategy that may reduce inflammation and pain level. ESTIVAL is a 12 weeks randomized sham-controlled trial investigating the symptomatic efficacy and safety of tVNS in patients with symptomatic and inflammatory EHOA. tVNS will be performed using a transcutaneous electrical nerve stimulation (TENS) device connected to an auricular electrode stimulating the cutaneous area of the left ear innervated by the auricular ascendant branch of the vagus nerve. The active and sham device's will display similar appearance but the sham one will not give electric signal.