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NCT ID: NCT04573023 Recruiting - Clinical trials for Mucopolysaccharidosis II

A Phase III Study of JR-141 in Patients With Mucopolysaccharidosis II (STARLIGHT)

Start date: February 14, 2022
Phase: Phase 3
Study type: Interventional

A Global Phase III multicenter, randomized, assessor-blinded, active-controlled designed to evaluate safety and efficacy of study drug for the treatment of the MPS II.

NCT ID: NCT04572854 Active, not recruiting - Renal Transplant Clinical Trials

Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN

NOBLE
Start date: February 23, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, open-label, randomized, controlled study designed to evaluate the safety and efficacy of pegcetacoplan in patients who have post-transplant recurrence of C3G or IC-MPGN.

NCT ID: NCT04572841 Completed - Sjogren's Syndrome Clinical Trials

Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS)

phaethuSA
Start date: November 12, 2020
Phase: Phase 2
Study type: Interventional

Primary Objective: To evaluate the therapeutic efficacy of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with primary Sjögren's syndrome (pSjS), assessed by the change of the European League Against Rheumatism (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI) Secondary Objectives: - To evaluate the therapeutic efficacy of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS - To evaluate the therapeutic efficacy on fatigue of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS - To evaluate the pharmacokinetic (PK) exposure of one dose level of SAR441344 over 12 weeks in adult patients with pSjS - To evaluate the safety and tolerability of one dose level of SAR441344 versus placebo in adult patients with pSjS as determined by adverse events (AEs) - To evaluate the local tolerability of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS - To evaluate the safety and tolerability of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS determined by electrocardiogram, vital signs, and laboratory evaluations - To measure the immunogenicity of one dose level of SAR441344 versus placebo over 12 weeks in adult patients with pSjS This is a multicenter, randomized, double blind, placebo controlled, parallel group proof of concept Phase 2 study to evaluate the therapeutic efficacy of SAR441344 in adult patients with primary Sjögren's syndrome (pSjS), as well as safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD). - Study visit frequency: every 2 weeks in the treatment period and every 4 weeks in the follow-up period. - The total duration of the study will be 24 weeks (28 weeks including maximum screening duration) for each participant, including a 12-week treatment period and a 12-week follow-up period.

NCT ID: NCT04572646 Terminated - Smoking Cessation Clinical Trials

Benefit of Systematic Proposition of Nicotine Substitution for Patients Undergoing Surgery

PATCHIR
Start date: August 24, 2020
Phase: N/A
Study type: Interventional

Smoking is associated with a higher rate of surgical complications. For example, in orthopedics, the risk of complications is 31% in smokers against 5% in non-smokers. The management of this addiction is recommended and particularly interesting in scheduled surgery, because it allows smoking cessation well before the procedure. However, for patients who cannot consider this smoking cessation, the mere information of the risk cannot be sufficient and a real strategy must be constructed and evaluated. Currently, studies results indicate that a patient reducing the number of smoked cigarettes will unconsciously modify their smoking behaviour to obtain the usual nicotine level, this effect is called self-titration. Conversely, nicotine replacement while continuing consumption could induce an improvement in smoking behaviour, therefore less intoxication which would be beneficial in terms of reduction of post-operative complications. This study seeks to assess the effectiveness of a systematic proposition of nicotine replacement therapy (NRT) in regular smokers. Tobacco addiction specialists have demonstrated that intoxication and dependence are well correlated with the exhaled carbon monoxide (CO) level, so this measurement will be used in addition to the patient's interview.

NCT ID: NCT04572230 Active, not recruiting - Clinical trials for Intracranial Aneurysm

International Post Market Surveillance Study of Intracranial Aneurysms Treated With an Endovascular Approach

IMPACT
Start date: December 21, 2020
Phase:
Study type: Observational

IMPACT is an observational, post market study designed to provide an ongoing safety and performance evaluation of Stryker Neurovascular devices used for the treatment of intracranial aneurysms with an endovascular approach.

NCT ID: NCT04572009 Completed - Type 1 Diabetes Clinical Trials

Validation of a Biomathematical Model to Help Identify the Parameters of Flexible Insulin Therapy

ModIF
Start date: January 12, 2021
Phase: N/A
Study type: Interventional

Type 1 diabetes is an autoimmune disease that requires daily treatment with insulin. The use of subcutaneous pumps for continuous insulin delivery has been an important advance for diabetic patients. The evolution of technologies through the miniaturization of insulin pumps and the advent of continuous glucose sensors has made it possible to understand the development of the artificial pancreas. Several teams are working on the development of an artificial pancreas with considerable progress in closed-loop insulin delivery, particularly during the night. The Laboratory of Digital Sciences of Nantes has developed a new bio-mathematical model describing the glucose-insulin dynamics, closer to the physiological reality of patients with type 1 diabetes. This model allows firstly to identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios). The objective of this study is to test the relevance of this bio-mathematical model to help the physician identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios).

NCT ID: NCT04571840 Recruiting - Prostate Cancer Clinical Trials

Prostate Imaging Using MRI +/- Contrast Enhancement

PRIME
Start date: April 5, 2022
Phase: N/A
Study type: Interventional

This prospective clinical trial (PRostate Imaging using Mri +/- contrast Enhancement (PRIME)) aims to assess whether biparametric MRI (bpMRI) is non-inferior to multiparametric mpMRI (mpMRI) in the detection of clinically significant prostate cancer. This means that we are comparing MRI scans that requires injection of IV contrast (the current standard practice) versus MRI scans that can be performed without IV contrast in the detection of prostate cancer.

NCT ID: NCT04571736 Recruiting - Thyroid Clinical Trials

Pilot Study for Thyroid Surgery by Preoperative Video Support and Personalized and Secure Web Platform

AMEDOP
Start date: November 18, 2020
Phase: N/A
Study type: Interventional

The medical information delivered to the patient before any surgery constitutes an essential and compulsory step during the initial management of the operated patient. There are different reasons for the quantity and quality of medical information retained by the patient. An internet platform with personalized and secure access has been developed. This platform contains, among other things, an explanatory video of thyroid surgery and allows the patient to have access to information on surgical management at any time. The investigators believe that unlimited access for the duration of the study to this platform could reduce the preoperative anxiety level of patients.

NCT ID: NCT04571216 Recruiting - Smoking Cessation Clinical Trials

Study Assessing Efficacy and Safety of NFL-101 as a Tobacco Cessation Therapy

CESTO2
Start date: September 1, 2021
Phase: Phase 2
Study type: Interventional

CESTO 2 is a 318 participants, 3-arm, multicentric, randomized, double-blind, placebo-controlled Phase II clinical trial. The main objectives are to select the most efficient dose and to assess long-term efficacy of NFL-101 compared to placebo, for abrupt cessation and for reduction before cessation.

NCT ID: NCT04570943 Recruiting - Clinical trials for Locally Advanced Pancreatic Adenocarcinoma

Sequential Treatment With GEMBRAX and Then FOLFIRINOX Followed by Stereotactic MRI-guided Radiotherapy in Patients With Locally Advanced Pancreatic Cancer

GABRINOX-ART
Start date: December 15, 2020
Phase: Phase 2
Study type: Interventional

The aim of this study is to demonstrate the efficacy of intensified and sequential chemotherapy (Gabrinox) comprising Gembrax regimen (Gemcitabine-Abraxane) followed by the Folfirinox regimen (5FU, Oxaliplatin and Irinotecan) in patients with locally advanced pancreatic adenocarcinoma. The study will also demonstrate the feasibility of combining this intensified chemotherapy with MRI-guided stereotactic radiotherapy in non-progressive patients after the chemotherapy by Gabrinox regimen.