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NCT ID: NCT03607916 Completed - Pregnant Women Clinical Trials

Estimation of the Effective Dose (ED) 95 of Intrathecal Hyperbaric Prilocaine 2% for Scheduled Cesarean Delivery.

Start date: February 2014
Phase: Phase 2
Study type: Interventional

Prilocaine is a local anesthetic drug which as an intermediate duration of action shorter than bupivacaine 0,5% that is usually used for spinal anesthesia in scheduled cesarean section. No study has yet investigated the use of hyperbaric (HB) prilocaine 2% for intrathecal anesthesia in cesarean section. The aim of this study is to determine the Effective Dose (ED) 95 of hyperbaric (HB) prilocaine 2% by using the Continual Reassessment Method (CRM)

NCT ID: NCT03607513 Completed - Healthy Clinical Trials

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-64264681 in Healthy Male and Female Participants

Start date: July 31, 2018
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of JNJ-64264681 in healthy participants after single and multiple oral doses.

NCT ID: NCT03606408 Completed - Cushing's Syndrome Clinical Trials

Roll-over Study in Patients With Endogenous Cushing's Syndrome for LCI699

Start date: October 5, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is the evaluation of long-term safety of osilodrostat in patients who have already received osilodrostat treatment in a previous Global Novartis-sponsored trial and who, based on investigators' judgement, will continue benefiting with its administration.

NCT ID: NCT03604705 Completed - Candidemia Clinical Trials

An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia

Start date: October 3, 2018
Phase: Phase 2
Study type: Interventional

This is a multicenter, open-label, non-comparative, single-arm study to evaluate the efficacy and safety of APX001 for the first-line treatment for candidemia including suspected or confirmed antifungal-resistant candidemia in non-neutropenic patients 18 yeas of age and older. Suspicion of antifungal-resistant candidemia is sufficient (documented resistance is not required for enrollment). The Study Drug Treatment Period of APX001 will be a maximum of 14 days. After completion of 14 days study drug therapy, if further antifungal treatment is indicated to complete treatment of candidemia in accordance with standard practice guidelines, fluconazole (unless susceptibility results warrant alternative antifungal therapy) may commence for up to a further 7 days. There will be a Follow up Period of 4 weeks (+4 days) after EOT. The total duration of participation in the study is up to approximately 7.5 weeks. This study will be conducted at approximately 20 sites in the United States and globally.

NCT ID: NCT03604471 Completed - Clinical trials for Hypercholesterolemia

Lipid-lowering Therapy Individualization

Start date: August 8, 2017
Phase: Phase 4
Study type: Interventional

This clinical study will explore individual factors influencing statin pharmacokinetics in a cohort of 150 patients treated with atorvastatin.

NCT ID: NCT03603106 Completed - Healthy Volunteers Clinical Trials

Pharmacokinetics, Pharmacodynamics Profile and Tolerance of P03277 in Healthy Subjects and Patients With Brain Lesions

Start date: November 25, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of this study was to evaluate the safety (clinical and biological) and pharmacokinetics (plasma and urine) profile of P03277 following single administration at ascending dose levels in healthy subjects.

NCT ID: NCT03602963 Completed - Clinical trials for Type 1 Diabetes Mellitus

Comparison Between Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System and the FreeStyle Libre Flash Glucose Monitoring System

Start date: July 9, 2018
Phase:
Study type: Observational

1. The accuracy of the sensors (Dexcom G5 vs FreeStyle Libre Flash glucose monitoring) will be evaluated by simultaneous wearing of the 2 sensors during 2 weeks. During these 2 weeks the patients will do at least four capillary blood glucose measurements to compare with the sensor results. 2. Patient satisfaction will be evaluated using a questionnaire that will be completed after the Dexcom G5 sensor has been worn for 1 month. 3. The data recorded by the FreeStyle Libre Flash glucose monitoring system (average glucose,% above target, % within target, % under target, amount of hypoglycemia) in the month prior to the 2 weeks of double sensor wear will be compared to the same data recorded by the Dexcom G5 mobile CGM system during the first month of use.

NCT ID: NCT03602560 Completed - Clinical trials for Primary Biliary Cholangitis

ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Start date: October 1, 2018
Phase: Phase 3
Study type: Interventional

A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.

NCT ID: NCT03600454 Completed - Surgery Clinical Trials

The Effect of Anesthesia on Perioperative Muscle Weakness and Neuro-endocrine Stress Response

MUSCLE
Start date: September 1, 2018
Phase: N/A
Study type: Interventional

The effect of surgery, in contrary to critical illness, on muscle weakness hasn't been thoroughly investigated. Recent data suggest that elective surgery may also induce muscle weakness. The neuro-endocrine stress response could be involved in the pathophysiology. Whether the mode of anesthesia/analgesia can influence muscle weakness, by influencing the neuro-endocrine stress response is unknown. Gaining insight in this matter could affect quality of care and benefit patient recovery and satisfaction.

NCT ID: NCT03599440 Completed - Clinical trials for Hemodynamic Instability

Effect of Extended Infusion Lines on Pulse Contour-based Measurements

Start date: September 15, 2018
Phase:
Study type: Observational

Hemodynamic monitoring of the critically-ill patients is increasingly performed using an arterial pulse contour-based cardiac output device such as the proAQT system. The aim of this study is to evaluate the effect of extending the pressure lines on the arterial pressure wave and the calculated hemodynamic variables when using the proAQT system.