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NCT ID: NCT03783494 Completed - Limb Fracture Clinical Trials

Target-controlled Infusion With Propofol in the Emergency Department : a Prospective Study on 45 Adult Patients

SIVOC
Start date: May 9, 2019
Phase: Phase 4
Study type: Interventional

Procedural sedation is an emergency medicine technique that provides a brief, deep sedation in order to perform very painful emergency emergent procedures such as displaced fracture or dislocated joints reduction. Propofol is recommended for this purpose, injected administered in slow IV bolus injections according to the technique known as manual titration. But despite this precaution, temporarily excessive sedation can happen, and a side effect can appear (arterial hypotension or respiratory depression). Target-controlled infusion (TCI) is an anesthesia technique that permits to obtain a precise constant and stable concentration of medication, boluses volumes of injection being calculated and delivered automatically by an electric syringe equipped with a software obedient to existing pharmacokinetic models. In the operating room, Ffor anesthetic induction, maintenance and awakening, respectively, in the operating room, the brain concentrations of propofol range respectively from 2 to 6 μg/mL, 2 to 4 μg/mL, and between 0.8 and 1.2 μg/mL, respectively. Since TCI has never been used in emergency departments (ED), the brain propofol concentrations which are necessary for sedation and awakening of the patient are not known and must be determined experimentally. In this single-center, prospective, interventional study, safety and feasibility of TCI will be studied in one ED with the primary objective of determining the brain propofol concentrations necessary to reach the an optimal sedation in for patients with indications of sustaining very painful orthopedic emergency emergent procedures

NCT ID: NCT03783078 Completed - Clinical trials for Merkel Cell Carcinoma

Pembrolizumab (MK-3475) as First-line Therapy for Advanced Merkel Cell Carcinoma (MK-3475-913)

Start date: February 25, 2019
Phase: Phase 3
Study type: Interventional

This is a single-arm, open-label, multicenter, efficacy, and safety study of pembrolizumab in adult and pediatric participants with previously untreated advanced Merkel Cell Carcinoma (MCC). The primary objective of the trial is to assess the objective response rate, as assessed by blinded independent central review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ, following administration of pembrolizumab.

NCT ID: NCT03782792 Completed - Clinical trials for Generalized Pustular Psoriasis

Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis

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

To evaluate efficacy, safety, and tolerability of spesolimab (BI 655130) compared to placebo in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe intensity.

NCT ID: NCT03782376 Completed - Crohn Disease Clinical Trials

A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease

POWER
Start date: December 20, 2018
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.

NCT ID: NCT03782129 Completed - Diabetes Mellitus Clinical Trials

Five-year Mortality Rate in People With Diabetic Foot Ulcer

DIAFOOT
Start date: March 2009
Phase:
Study type: Observational

As the global mortality rate decreases for diabetics patients, further explorations and datas are needed about the specific population of diabetics patients suffering a Diabetic Foot Ulcer (DFU). This study investigates the 5 years mortality rate in patients with a diabetic foot ulcer occurring in 2010.

NCT ID: NCT03781414 Completed - Clinical trials for Liver Transplant Rejection

Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension

CONTRAIL I
Start date: October 7, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study was to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of two CFZ533 dose regimens in liver transplant recipients.

NCT ID: NCT03780920 Completed - Clinical trials for Head Turn Preference

Preventive Osteopathic Treatment of Plagiocephaly

TOPP PLAGIO
Start date: February 14, 2019
Phase: N/A
Study type: Interventional

Positional cranial deformities (PCD), plagiocephaly and brachycephaly are a common reason for pediatric consultation, which has increased significantly since the recommendation to lay babies on their backs to prevent unexpected infant death (ILD). CPD is a source of concern for parents about their impact on psychomotor development and the aesthetic risk of deformity. The High Authority for Health (HAS) will soon put in place recommendations with a fact sheet for health professionals and the public. The aim of this research is to study whether early treatment of rotation disorders and hypertonia in newborns by manual osteopathic techniques would prevent the occurrence of positional deformities of the skull. The main objective is to evaluate the effectiveness of an early osteopathic treatment on the rate of CPP (plagiocephalic and postural brachycephalia) at 4 months in newborns at risk. the secondary objective is: to evaluate the effectiveness of an early osteopathic treatment on the quality of life of the child at 4 months. Methodology: Controlled, randomized monocentric two-arm parallel study between (1) osteopathic follow-up and (2) osteopathy-free follow-up. The inclusion period will be 18 months and the follow-up period is 4 months. Procedure: The two groups will be evaluated at 3 days and 4 months. The experimental group will benefit from an osteopathic treatment of 3 days of life to 4 months with a frequency of 3 to 4 sessions. Both groups will benefit from sleeping, carrying, positioning and stimulation advice. The perspectives are: - the decrease in the prevalence of CPP after early osteopathic treatment. - Defining a decision algorithm for early osteopathic treatment. - Subject to recommendations on the indication of early osteopathic treatment in neonates at risk.

NCT ID: NCT03780673 Completed - Liver Cirrhoses Clinical Trials

Efficacy of the Combination of Simvastatin Plus Rifaximin in Patients With Decompensated Cirrhosis to Prevent ACLF Development

2018-001698-25
Start date: January 3, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this study is to assess the efficacy of oral administration of simvastatin plus rifaximin in patients with decompensated cirrhosis to halt the progression of the disease as assessed by prevention of the development of ACLF

NCT ID: NCT03780517 Completed - Clinical trials for Advanced Nonhaematologic Malignancies

Safety, Efficacy, and Tolerability of BOS172738 in Patients With Advanced Rearranged During Transfection (RET) Gene-Altered Tumors

Start date: December 12, 2018
Phase: Phase 1
Study type: Interventional

This study will be conducted to assess the safety and tolerability of BOS172738 when administered to patients with advanced solid tumors with rearranged during transfection (RET) gene alterations and also to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of BOS172738.

NCT ID: NCT03780257 Completed - Clinical trials for Retinitis Pigmentosa

Study to Evaluate Safety and Tolerability of QR-421a in Subjects With RP Due to Mutations in Exon 13 of the USH2A Gene

Stellar
Start date: March 6, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of QR-421a administered via intravitreal injection (IVT) in subjects with Retinitis Pigmentosa (RP) due to mutations in exon 13 of the USH2A gene.