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NCT ID: NCT03786640 Completed - Fatigue Clinical Trials

Abbott Brady 3T MRI PMCF

Start date: October 4, 2019
Phase:
Study type: Observational

The objective of this post-market, clinical follow up (PMCF) study, is to confirm the long-term safety of the Tendril STS and Isoflex leads, implanted with the Assurity MRI™ or Endurity MRI™ pacemakers, in patients undergoing a clinically indicated 3T MRI (3 Tesla Magnetic Resonance Imaging) scan.

NCT ID: NCT03786406 Completed - Clinical trials for Diabetes Mellitus, Type 2

An International Survey of the Occurrence of Diseases That Affects the Heart and Blood Vessels Among People With Type 2 Diabetes

EU-CAPTURE
Start date: December 3, 2018
Phase:
Study type: Observational

The purpose of the study is to register the occurrence of cardiovascular disease among type 2 diabetes (T2DM) patients across five selected countries in Europe. Participants will be asked to give information about their health. Participants will continue their normal way of life and will not get any medication other than what has been prescribed to them by their doctor. Participants' participation will be one day/one visit at study doctor. The study will last for about 3 months in total.

NCT ID: NCT03785925 Completed - Neoplasm Metastasis Clinical Trials

A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer

PIVOT-10
Start date: April 29, 2019
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.

NCT ID: NCT03785405 Completed - Heart Failure Clinical Trials

CLCZ696B2319E1 OL Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF

Start date: May 2, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate long-term safety and tolerability data in eligible CLCZ696B2319 (PANORAMA-HF) patients receiving open-label sacubitril/valsartan.

NCT ID: NCT03784937 Completed - Clinical trials for Deep Vein Thrombosis

Revaluation of Wells' Clinical Prediction Score of Deep Vein Thrombosis (DVT) in Inpatients With Thromboprophylaxis Treatment

R-WITT
Start date: February 1, 2018
Phase:
Study type: Observational

This study aimed (1) revaluating the efficacy of the Wells' clinical prediction score for an inpatient population; and the weight of the presence of thromboprophylaxis treatment on the score, and (2) evaluating the correlation of a risk stratification established between a physician specialised in thrombosis and any other doctor.

NCT ID: NCT03784664 Completed - Acid Base Disorder Clinical Trials

Reducing Pain in Emergency Department by Using Veinous Blood Gas Instead of Arterious Blood Gas

VEINART
Start date: January 20, 2019
Phase: N/A
Study type: Interventional

Blood gases are widely used in emergency and resuscitation services and are the key examination for exploring acid-base balance disorders (using pH, PaCO2 and HCO3 ) and gas exchange disorders (using PaO2 and PaCO2). This examination can be taken from both venous and arterial sample and its analysis depends on the type of blood sample. Currently, several studies have already shown the existence of a good correlation of pH and bicarbonates level between a venous and arterial sample. Thus, when this examination is prescribed for the purpose of highlighting and analyzing an acid-base disorder, venous blood gas is theoretically as efficient as arterial blood gas. Due to the lack of evidence of benefit for the patient or the health care team of a venous blood gas rather than an arterial blood gas in the absence of suspicion of hypoxemia, arterial blood gas is currently the standard of care for the analysis of acid-base disorders. Indeed, among the university hospitals affiliated to the Paris Diderot University, the emergency departments carry out in their vast majority (4 of 5 E.D.) arterial blood gases. Demonstration of the superiority of veinous sample over arterial sample regarding pain could substantially modify current practices. The investigator's main hypothesis is that, in the absence of suspicion of hypoxemia (normal oxygen saturation measured by plethysmography), the realization of a venous blood gas for the evaluation of the acid-base balance in the context of emergencies is less painful for patients, simpler for the health care team and provides sufficient biochemical information for the doctor in comparison with an arterial blood gas.

NCT ID: NCT03784482 Completed - Drug Allergy Clinical Trials

Multiple Drug Hypersensitivity Syndrome

MDH
Start date: December 20, 2018
Phase:
Study type: Observational

Background: Multiple drug hypersensitivity syndrome (MDH) is defined as confirmed drug hypersensitivity reactions (DHRs) to at least 2 chemically and pharmacologically unrelated drugs. Reports of MDH are scarce and poorly specified and studies which diagnose MDH on the basis of positive allergy tests are lacking. Objective: To evaluate retrospectively the frequency and characteristics of MDH patients in a large database. Methods: All the patients who consulted and were tested in our Allergy Unit between September 1996 and February 2018, with confirmed MDH will be included. Clinical history and allergy work-up results will be extracted from our Drug Allergy and Hypersensitivity Database (DAHD). The frequency of MDH will be calculated, MDH patients will be described, the most frequent associations of DHRs will be identified and analysed.

NCT ID: NCT03784157 Completed - Ischemia Clinical Trials

Study Of The Metabolic Parameters Of Uterine Muscle Cells

Start date: December 13, 2018
Phase:
Study type: Observational

To date, no transplant has allowed pregnancy from a donor in a state of brain death. One of the main reservations lies in the ischemic properties of the uterine graft between the sampling time and the grafting time. Investigators propose to carry out a prospective monocentric study at the University Hospitals of Strasbourg in 2018/2019: the objective would be to study physiologically the time of ischemia of the uterine muscle The objective is to carry out a preparatory study on healthy uteri to study the ischemic properties of uterine muscle from living markers: study of mitochondrial respiration and free radical production on uterine muscle samples If the markers are reliable, they would then be used to measure the ischemia of whole uteri collected at the end of the multi-organ retrieval process from donors in a state of brain death and stored in tissue survival media.

NCT ID: NCT03784079 Completed - HIV Infections Clinical Trials

A Proof of Concept Study of GSK3640254 in Human Immunodeficiency Virus-1 (HIV-1) Infected Treatment-naive Adults

Start date: January 31, 2019
Phase: Phase 2
Study type: Interventional

Infection with HIV-1 continues to be a serious health threat throughout the world. Chronic exposure to combination anti-retroviral therapy identified anti-retroviral associated long-term toxicities. Hence, there is a need to prevent these co-morbidities. GSK3640254 is a next-generation HIV-1 Maturation Inhibitor (MI) which may be effective for HIV-1 infection. This study will evaluate the antiviral effect, safety, tolerability and pharmacokinetics/ pharmacodynamics of GSK3640254 in HIV-1 infected treatment-naive adults. This study will consists of two parts; Part 1 and Part 2. Part 1 will evaluate two active doses of GSK3640254, 200 milligrams (mg) (Cohort 1) and 10 mg (Cohort 2) along with placebo to match GSK3640254 Mesylate salt. Part 2 will evaluate three active doses of GSK3640254. Dose level 1 of GSK3640254 that can provide at least 30 percent of the maximum effect (Cohort 1), dose level 2 of GSK3640254 that can provide at least 75 percent of the maximum effect (Cohort 2) and dose level 3 of GSK3640254 that can provide at least 90 percent of the maximum effect (Cohort 3). These doses are anticipated to be 5 mg, 40 mg and 100 mg respectively, but could be modified based on data obtained in Part 1. Subjects will also receive placebo to match GSK3640254 Mesylate salt in Part 2 of the study. All doses will be administered after a moderate fat meal. This study will consist of Screening period (up to 14 days), Treatment period (Day 1- Day 10), post-dose Follow-up (Day 11- Day 17) and final Follow-up (Day 18-24). A total of approximately 34 subjects will be enrolled, of which, 14 subjects will be randomized in Part 1 and 20 in Part 2 of the study. Six subjects will be enrolled in each of the active dose cohorts and 2 subjects will be enrolled in each of the placebo cohorts.

NCT ID: NCT03783949 Completed - Ovarian Cancer Clinical Trials

European Trial on Enhanced DNA Repair Inhibition in Ovarian Cancer

EUDARIO
Start date: November 30, 2018
Phase: Phase 2
Study type: Interventional

This study will be performed in women with platinum-sensitive, high-grade serous, high-grade endometrioid, undifferentiated epithelial ovarian cancer, carcinosarcoma, fallopian tube or primary peritoneal cancer (proven by central histo-pathological review). A total of 120 subjects will be randomized (1:1:1) to three different treatment arms: (A) Standard arm (arm A): Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175 mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000 mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral daily, q4w) // (B) First experimental arm (arm B): Ganetespib (150 mg/m2, d1, q3w) in combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment with Niraparib (200/ 300 mg oral daily, q4w) // (C) Second experimental arm (arm C): Ganetespib (150 mg/m² d1, q3w i.v.) plus Carboplatin (AUC5 d1, q3w i.v.) followed by Ganetespib (100 mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w). Chemotherapy treatment will be given for 6 cycles, maintenance treatment with Ganetespib will be given for a maximum of 9 months or until disease progression, maintenance treatment with Niraparib can continue until disease progression.