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NCT ID: NCT03406507 Completed - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

A Study of Ravulizumab (ALXN1210) in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria

Start date: February 22, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study was to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy of ravulizumab in pediatric participants with paroxysmal nocturnal hemoglobinuria (PNH).

NCT ID: NCT03406468 Completed - Clinical trials for Non-Small Cell Carcinoma of Lung, TNM Stage 4

Re-Induction After Initial Response With Immune Therapy With Radiotherapy in Lung Cancer

Start date: July 15, 2019
Phase: Phase 2
Study type: Interventional

Radiotherapy in combination with different forms of immune therapy improved consistently local tumor control and very interestingly, lead to better systemic tumor control and the induction of specific anti-cancer immunity with a memory effect. In small series, it has been shown that a new long-lasting remission can be induced by irradiating one tumor site in patients who showed cancer progression after an initial response to immune therapy. In these series, the original immune therapy was continued and the treatment was very well tolerated. In this study the progression-free survival after radiotherapy to a single lesion will be investigated in patients with stage IV non-small cell lung cancer (NSCLC), who have at least achieved stable disease with immune therapy alone or concurrent immune therapy and chemotherapy.

NCT ID: NCT03405545 Completed - Clinical trials for Overweight and Obesity

High Intensity Interval Training and Skeletal Muscle Insulin Sensitivity

Start date: March 28, 2018
Phase: N/A
Study type: Interventional

This human intervention study will test if 12 weeks of supervised HIIT-based intervention improves skeletal muscle NOGD capacity in obese subjects.

NCT ID: NCT03405441 Completed - Healthy Clinical Trials

A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-55375515 in Healthy Male Participants

Start date: January 2, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess safety and tolerability of day-time and night-time dosing of JNJ‑55375515 in healthy male participants.

NCT ID: NCT03402841 Completed - Clinical trials for Non-Germline BRCA Mutated Ovarian Cancer

Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients

OPINION
Start date: January 30, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the efficacy and safety of single-agent olaparib as a maintenance treatment in patients with relapsed High Grade Serous Ovarian Cancer (including patients with primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer who do not have known deleterious or suspected deleterious germline BRCA mutations (non-gBRCAm) and who had responded following platinum based chemotherapy

NCT ID: NCT03402659 Completed - Alzheimer Disease Clinical Trials

Proof-of-Concept Study of a Selective p38 MAPK Alpha Inhibitor, Neflamapimod, in Subjects With Mild Alzheimer's Disease

REVERSE-SD
Start date: December 29, 2017
Phase: Phase 2
Study type: Interventional

This is a phase 2b, double-blind, placebo controlled proof-of-concept study of a an oral small molecule selective inhibitor of p38 alpha kinase, neflamapimod, administered for 24 weeks in subjects with mild Alzheimer's disease. The primary objective is to demonstrate significant improvement relative to placebo-treatment in episodic memory function, as assessed by the Hopkins Verbal Learning Test. Secondary endpoints include Clinical Dementia Rating scale (CDR), Wechsler Memory Scale (WMS), Mini-Mental-Status-Examination (MMSE) and Cerebrospinal fluid (CSF) biomarkers of AD disease activity and progression.

NCT ID: NCT03402087 Completed - Psoriatic Arthritis Clinical Trials

A Study to Investigate BMS-986165 and Methotrexate in Healthy Male Patients

Start date: January 8, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate effects of BMS-986165 on blood levels of methotrexate given as a single dose in healthy male patients.

NCT ID: NCT03400904 Completed - Brain Injuries Clinical Trials

Extubation Strategies in Neuro-Intensive Care Unit Patients and Associations With Outcome.

ENIO
Start date: September 6, 2018
Phase:
Study type: Observational

Rationale Prolonged mechanical ventilation (MV) is common in patients with severe Brain Injury (BI). Guidelines for the management of extubation are largely lacking for patients with BI, and the role of tracheostomy is highly uncertain. More important, data on practice of management of extubation is yet underreported, as is the use of tracheotomy in this specific subset of critical care patients. Objective The objective of this prospective observational study is to describe the management of extubation and tracheostomy in intensive care unit (ICU) patients with BI. The aim is to describe the incidence of extubation failure and the rate of tracheostomy. Study design The "Extubation strategies in Neuro-Intensive care unit patients, and associations with Outcomes (ENIO)" is an observational multicentre international cohort study. Study population The investigators will include patients undergoing BI, with an initial Glasgow Coma Score ≤ 12 and with a delivered duration of mechanical ventilation (MV) ≥ 24 hours at ICU admission. The inclusion period will last 6 months in total, and each centre is expected to include at least 24 patients during this period. With over 60 ICUs participating worldwide, we expect to include 1500 patients. Main parameters Parameters to be collected include: general neurological management, ventilatory management, general ICU complications, specific data on extubation and tracheostomy, general in-ICU outcomes and in-hospital mortality. Nature and extent of the burden and risks associated with participation Because of the observational design of the study using routinely collected data, there is no additional burden for the patient. Collection of data from ICU charts and/or (written or electronic) medical records systems bears no risk to the patients.

NCT ID: NCT03400267 Completed - STEMI Clinical Trials

The Effect of Opioids on P2Y12 Receptor Inhibition in Patients With ST-Elevation Myocardial Infarction Who Are Pre-treated With Crushed Ticagrelor

ON-TIME 3
Start date: February 16, 2018
Phase: Phase 4
Study type: Interventional

Fast and accurate platelet inhibition is an important therapeutic goal in the acute treatment of patients with ST-segment elevation myocardial infarction (STEMI). Platelet inhibitory effects induced by normal oral P2Y12 receptor antagonists, for example ticagrelor, are delayed in STEMI patients undergoing primary percutaneous coronary intervention (primary PCI), which may be attributed to impaired absorption affecting drug pharmacokinetics (PK) and pharmacodynamics (PD). Another therapeutic goal in the acute treatment of STEMI is reduction of sympathetic stress and catecholamine release, thereby improving the balance between the demand for and supply of oxygen, by analgesia like fentanyl of morphine. To date, there are no studies that have specifically assessed the pharmacodynamics influences of fentanyl on platelet inhibition in STEMI patients who are pre-treated with crushed ticagrelor tablets. Therefore, In the ON-TIME-3 study, the investigators seek to show the influence of fentanyl on platelet inhibition in STEMI patients who are pre-treated with crushed ticagrelor in the ambulance.

NCT ID: NCT03400150 Completed - Prostate Cancer Clinical Trials

ProSpace™ Balloon System Pivotal Study BP-007

Start date: January 3, 2018
Phase: N/A
Study type: Interventional

The ProSpace™ System is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of the ProSpace System to reduce the radiation dose delivered to the anterior rectum. ProSpace is a balloon composed of a biodegradable material that maintains that space for the entire course of prostate radiotherapy treatment and is completely absorbed by the patient's body over time.