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NCT ID: NCT04559633 Active, not recruiting - Adolescent Clinical Trials

Cognitive and Behavioral Therapy in School Refusal

RSA-Coll
Start date: September 22, 2020
Phase: N/A
Study type: Interventional

Anxious school refusal (ASR) is a common disorder which concerns more and more adolescents who are at worse completely absent from school. A specific ambulatory cognitive and behavioral therapy (CBT) program has been established to gradually reintegrate the child back into the school environment with a multidisciplinary team. Alongside school reintegration assessment, the child's overall ability to function and anxiety levels will be measured before and after the program with additional assessments made after a further 6 and 12 months have elapsed.

NCT ID: NCT04559464 Active, not recruiting - COPD Clinical Trials

Fissure Closure With the AeriSeal System for CONVERTing Collateral Ventilation Status (CONVERT)

CONVERT
Start date: December 15, 2020
Phase: N/A
Study type: Interventional

This is a prospective, open-label, multi-center, single-arm study to be conducted at up to 20 investigational sites. The Study plans to enroll up to 140 subjects with severe emphysema and collateral ventilation in the target lobe. This protocol is designed to evaluate the utility of the AeriSeal System to occlude collateral air channels in a target lung lobe with collateral ventilation (CV) and convert the target lung lobe to having little to no collateral ventilation. Subjects can then receive Zephyr Valves to achieve atelectasis in the targeted lobe, once AeriSeal has converted the CV+ lobe to a CV- one. Therefore, the study will have two Stages: • Stage 1 will address the closure of the lobar fissure gaps (or collateral air channels) to block collateral ventilation (CV) with the AeriSeal System; conversion of the CV+ target lobe to CV-. Conversion of collateral ventilation will be evaluated by Chartis after 45 days. In the case of unsuccessful conversion, a second treatment of AeriSeal may be attempted, provided that the total application volume from both the initial and the repeat treatments does not exceed 40 mL in up to three (3) segments. Clinical Assessments post-AeriSeal will be conducted at 28 and 45 days after first treatment and repeated after the second treatment, if applicable. For the purpose of protocol follow-up, the Day 45 post-AeriSeal final treatment will equal Day 0 for Stage 2. • Stage 2 will include successfully converted subjects; CV+ to CV- conversion in Stage 1. Converted CV- target lobes will follow standard of care and receive CE marked Zephyr Endobronchial valves per the Zephyr IFU to perform bronchoscopic lung volume reduction (BLVR). Clinical assessments will be conducted at 45 Days, 3-months, 6-months, and 12-months post-Zephyr Valve procedure.

NCT ID: NCT04557098 Active, not recruiting - Clinical trials for Hematological Malignancies

A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma

MajesTEC-1
Start date: September 17, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of teclistamab at the recommended Phase 2 dose (RP2D).

NCT ID: NCT04556773 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer

DB-08
Start date: December 17, 2020
Phase: Phase 1
Study type: Interventional

DESTINY-Breast 08 will investigate the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies in patients with Metastatic HER2-low Advanced or Metastatic Breast Cancer

NCT ID: NCT04556656 Active, not recruiting - Huntington Disease Clinical Trials

PRidopidine's Outcome On Function in Huntington Disease, PROOF- HD

Start date: October 16, 2020
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of pridopidine 45mg twice daily (BID) in patients with early stage manifest Huntington Disease (HD).

NCT ID: NCT04555291 Active, not recruiting - Clinical trials for Total Hip Arthroplasty

Analgesic Effect of the QLB-3 for Patients Undergoing a Total Hip Surgery

QLB-3
Start date: January 5, 2022
Phase: N/A
Study type: Interventional

Total hip arthroplasty (THA) is one of the main elective orthopedic surgery. Recent studies have proven that patients undergoing an elective THA who are part of a fast track surgery program including an opioid free anesthesia (OFA) presented a decrease of mortality and a reduced in-hospital length of stay. Based on the anatomical knowledges, the Quadratus Lumborum Block seems to be an interesting locoregional technique for patients undergoing THA. So far, there is no recommanded locoregional aesthesia in this indication. The investigators hypothezised that QLB would give an efficient analgesia in the 24h following a THA. Therefor, the study performed a prospective, randomized, double blind trial in the Nice Universitary hospital of Pasteur 2 and in Arnault Tzanck Institute among all patients who underwent THA, comparing a QLB using ropivacaïne 2mg/ml 20ml vs isotonic saline solution 20 ml.The main end-point is the decrease opiod consumption in the 24h following THA.

NCT ID: NCT04555174 Active, not recruiting - Clinical trials for Coronary Artery Disease

BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry

BIOFLOW-VIII
Start date: September 25, 2020
Phase:
Study type: Observational [Patient Registry]

The BIOFLOW-VIII registry is a post-market clinical evaluation of the Orsiro Mission stent in subjects requiring coronary revascularization with Drug Eluting Stents (DES).

NCT ID: NCT04554849 Active, not recruiting - Gender Dysphoria Clinical Trials

Demographic Characteristics and Psychosocial Health of Transgender People

DyGeDem
Start date: July 24, 2020
Phase:
Study type: Observational

To study demographic characteristics of subjects referred to endocrine care for gender dysphoria and their psychosocial health

NCT ID: NCT04554602 Active, not recruiting - Endometriosis Clinical Trials

Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions

ENDOFUSION
Start date: March 1, 2021
Phase:
Study type: Observational

The aim of the study is evaluate the fusion ultrasound performance compared to MRI and coelioscopy diagnosis when a surgical intervention is performed.

NCT ID: NCT04551495 Active, not recruiting - Clinical trials for HER2-negative Breast Cancer

Neoadjuvant Study of Targeting ROS1 in Combination With Endocrine Therapy in Invasive Lobular Carcinoma of the Breast (ROSALINE)

ROSALINE
Start date: January 14, 2021
Phase: Phase 2
Study type: Interventional

Despite different clinical characteristics including the response to treatment and the patterns of metastatic relapse, invasive lobular breast carcinoma (ILBC) is treated like invasive ductal breast carcinoma (IDBC) carcinoma both in the clinics and in clinical trials. A large majority of ILBC are ER+/HER2- and almost 90% have loss of E-cadherin (CDH1) expression. A non-clinical study of CDH1 synthetic lethality interactions has identified ROS1 as a potential target. In vivo, ROS1 inhibitors produced profound antitumor effects in multiple models of E-cadherin-defective breast cancer, providing the preclinical rationale for assessing ROS1 inhibitors in this setting. Endocrine therapy being the mainstay of therapy for ER+/HER2- ILBC and the pre-operative setting offering a platform for rapid drug evaluation and biomarker research, the ROSALINE phase 2 study will evaluate the efficacy of Entrectinib (a potent inhibitor of ROS1 among other targets) in combination with letrozole (+ goserelin in premenopausal women) in the early setting of ILBC (stages 1 to 3). The neoadjuvant therapy will last 4 months and post-operative therapy will follow local practice. Biomarker research will include RNA sequencing of initial biopsies and surgical specimens, as well as liquid biopsies.