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NCT ID: NCT04754217 Recruiting - Clinical trials for Aortic Valve Disease

Valved Graft PMCF Study

Start date: July 13, 2021
Phase:
Study type: Observational

Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.

NCT ID: NCT04754087 Recruiting - Osteoarthritis, Hip Clinical Trials

G7 Acetabular System With Vivacit-E or Longevity Liner PMCF Study

Start date: July 7, 2021
Phase: N/A
Study type: Interventional

The main objectives of this study are to confirm the long-term safety, performance, and clinical benefits of the G7 Acetabular Shells when used with the Vivacit-E and Longevity HXLPE liners and instrumentation in primary and revision total hip arthroplasty.

NCT ID: NCT04752826 Recruiting - Clinical trials for Advanced Malignancies

BI-1808 as a Single Agent and With Pembrolizumab (KEYTRUDA® ) in Treatment of Advanced Malignancies(Keynote-D20)

Start date: January 25, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2a, dose-escalation, multicenter, first-in-human, consecutive-cohort, open-label study of BI-1808, as a single agent and in combination with pembrolizumab in subjects with advanced malignancies, whose disease has progressed after standard therapy. For the purpose of this study, subjects with advanced malignancies includes subjects with advanced solid tumors (where iRECIST can be applied for efficacy assessment) and subjects with cutaneous T-cell lymphoma (CTCL), specifically Sézary Syndrome (SS) and mycosis fungoides (MF). The study will consist of 2 phases: a Phase 1 with Parts A and B, and a Phase 2a with Parts A and B. All subjects participating in the trial will complete a follow-up portion of the trial and an End of Treatment (EOT) Visit 30 days (±3 days) after their last dose of BI-1808.

NCT ID: NCT04751487 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) (AERIFY-2)

Start date: February 12, 2021
Phase: Phase 3
Study type: Interventional

Primary Objective: Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD Secondary Objectives: Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD - Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD - Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD - Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD Secondary population (current smokers cohort) - Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD - Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD - Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD - Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD - Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD

NCT ID: NCT04750694 Recruiting - Hypertrophy Clinical Trials

High Intensity Resistance Training Combined With Blood Flow Restricted Exercise in Elite Handball Players

Start date: November 1, 2020
Phase: N/A
Study type: Interventional

Purpose of the study is: to investigate the effects of 8 weeks intervention of high intensity resistance training(HIRT) combined with Blood Flow Restricted Exercise (BFRE) compared to high intensity resistance training alone. Detailed Description: 30 elite handball players will be randomized into 2 groups of 15 participants each. Participants will be evaluated in the week before and the week after an 8-weeks training intervention with 2 weekly sessions. Based on their baseline muscle strength the participants will be randomized into two groups: HIRT-BFRE or HIRT-HIRT. Participants in both groups will perform a full-body training programme of HIRT. After the Full-body programme, Back squat exercise with low intensity and Blood flow restriction will be performed to the HIRT-BFRE group and back squat exercise with high intensity without blood flow restriction will be performed by HIRT-HIRT. Evaluation protocol includes: muscle strength measurement with 1 repetition maximum of Back squat and knee extension, muscle mass with Dual-Energy X-ray absorptiometry, muscle thickness of the thigh with ultra sound measurement, vertical jump height with linear Encoder, sprint performance with 30m sprint time.

NCT ID: NCT04748874 Recruiting - Infertility Clinical Trials

Immediate Versus Postponed Single Blastocyst Transfer in mNC-FET

Start date: April 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this randomized controlled trial is to investigate if immediate single blastocyst transfer (in the first menstrual cycle following oocyte retrieval) is non-inferior to standard postponed single blastocyst transfer (in the second or subsequent menstrual cycle following oocyte retrieval) in modified natural cycle frozen-thawed embryo transfer (mNC-FET) in terms of live birth rate.

NCT ID: NCT04746729 Recruiting - Neoplasms Clinical Trials

Health Effects of CArdiac FluoRoscopy and MOderN RadIotherapy in PediatriCs - Radiotherapy

HARMONIC-RT
Start date: January 11, 2021
Phase:
Study type: Observational [Patient Registry]

The goal of the HARMONIC-RT study is to evaluate late health and social outcomes of contemporary techniques of external beam radiotherapy in paediatric patients, based on the setting-up of a European, long-term registry complemented by a biobank.

NCT ID: NCT04744129 Recruiting - Headache, Migraine Clinical Trials

Headache Inducing Effect of NN414 in Migraine Patients

Start date: February 25, 2022
Phase: N/A
Study type: Interventional

To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.

NCT ID: NCT04742075 Recruiting - Ovarian Cancer Clinical Trials

Olaparib, Durvalumab and UV1 in Relapsed Ovarian Cancer

DOVACC
Start date: December 15, 2021
Phase: Phase 2
Study type: Interventional

This prospective, multicenter, open-label, randomized phase II maintenance study is evaluating the efficacy of UV1-olaparib-durvalumab combination as maintenance therapy after platinum combination therapy for BRCAwt patients with relapsed ovarian cancer.

NCT ID: NCT04742010 Recruiting - Bariatric Surgery Clinical Trials

Zoledronic Acid for Prevention of Bone Loss After BAriatric Surgery (ZABAS)

ZABAS
Start date: February 20, 2021
Phase: Phase 2
Study type: Interventional

In a randomised placebo-controlled trial assess effects of zoledronic acid for prevention of bone and muscle loss after bariatric surgery.