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NCT ID: NCT04464434 Recruiting - Systemic Sclerosis Clinical Trials

Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis

UPSIDE
Start date: September 17, 2020
Phase: Phase 4
Study type: Interventional

HSCT has been implemented in (inter)national treatment guidelines for diffuse cutaneous systemic sclerosis (dcSSc) and is offered in clinical care and reimbursed by national health insurance in several European countries. However, data and specific guidelines on the best timing of HSCT in the course of dcSSc are lacking. In particular, it is unclear whether HSCT should be positioned as upfront therapy or as rescue treatment for patients not responding to conventional immunosuppressive therapy. This multicentre, randomized, open label trial aims to compare two treatment strategies used in usual care: upfront autologous HSCT versus usual care with (intravenous (i.v.) cyclophosphamide (CYC) pulse therapy followed by mycophenolate mofetil (MMF) and HSCT as rescue option).

NCT ID: NCT04464226 Recruiting - Cancer Clinical Trials

Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

Start date: October 20, 2020
Phase: Phase 3
Study type: Interventional

The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor's visits as often as they did in the previous study.

NCT ID: NCT04462042 Recruiting - Clinical trials for Anal Cancer Squamous Cell

Proton Versus Photon Therapy in Anal Squamous Cell Carcinoma

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

Dosimetric studies suggest that radiotherapy with protons has a potential to reduce side effects compared to treatment with photons for patients with anal carcinoma (AC). There are so far no studies comparing these treatment techniques in a randomised setting. The aim of this study is to compare side effects following photon therapy versus proton therapy within the framework of a randomised controlled trial.

NCT ID: NCT04460352 Recruiting - Clinical trials for Esophageal Squamous Cell Carcinoma

Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer

NEEDS
Start date: November 27, 2020
Phase: Phase 3
Study type: Interventional

NEEDS is a pragmatic open-label, randomised, controlled, phase III, multicenter trial with non-inferiority design with regard to the first co-primary endpoint overall survival and superiority for the experimental intervention definitive chemoradiotherapy. A second co-primary endpoint is global health related quality of life (HRQOL) one year after randomisation. A third co-primary endpoint is eating restictions one year after randomisation. The aim is to compare outcomes after neoadjuvant chemoradiotherapy with subsequent esophagectomy to definitive chemoradiotherapy with surveillance and salvage esophagectomy as needed in patients with resectable locally advanced squamous cell carcinoma (SCC) of the esophagus, with the aim to provide generalisable guidance for future clinical practice.

NCT ID: NCT04458207 Recruiting - Cognitive Decline Clinical Trials

Cognitive Changes and Neural Correlates After Rehabilitation of Masticatory Function in Elderly -an Intervention Study

Start date: November 2, 2018
Phase: N/A
Study type: Interventional

Today in elderly tooth loss and loss of oral function is widespread, but it is an underexplored modifiable risk factor potentially contributing to the development of dementia. In this interventional study a "cause-effect" relationship between mastication and cognition in humans will be investigated. A total of eighty (80) participants, 65-80 years of age, indicated for prosthodontic rehabilitation will be randomly assigned to either the experimental or the control group. Participants will be randomized into two different groups, measurements are going to be conducted before and after prosthetic rehabilitation. The difference between the two groups is that the control group are going to do two measurements before undergoing the rehabilitation, this to control for the test-re-test effect. The aim with this study is to determine if the rehabilitation of chewing function will cause changes in the neurocognitive assessments of episodic memory and learning.

NCT ID: NCT04458051 Recruiting - Clinical trials for Primary Progressive Multiple Sclerosis

Primary Progressive Multiple Sclerosis (PPMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (PERSEUS)

PERSEUS
Start date: August 13, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: To determine the efficacy of SAR442168 compared to placebo in delaying disability progression in primary progressive multiple sclerosis (PPMS) Secondary Objectives: To evaluate efficacy of SAR442168 compared to placebo on clinical endpoints, magnetic resonance imaging (MRI) lesions, cognitive performance, physical function, and quality of life To evaluate safety and tolerability of SAR442168 To evaluate population pharmacokinetics (PK) of SAR442168 in PPMS and its relationship to efficacy and safety To evaluate pharmacodynamics of SAR442168

NCT ID: NCT04450758 Recruiting - Colon Cancer Clinical Trials

Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma

ACBC
Start date: September 1, 2020
Phase:
Study type: Observational

P) patients with acute obstructive colon cancer I) resection or bridge to surgery with stent or stoma C) emergency procedure O ) morbidity and mortality within 30 days, 90 day mortality and 3 & 5 years overall survival

NCT ID: NCT04449991 Recruiting - Lupus Nephritis Clinical Trials

Per-protocol Repeat Kidney Biopsy in Incident Cases of Lupus Nephritis

REBIOLUP
Start date: January 5, 2022
Phase: N/A
Study type: Interventional

Lupus nephritis (LN) is one of the most severe complications of systemic lupus erythematosus (SLE). Among people living with SLE, 35-60% will develop LN during the course of the disease. This complication is one of the factors that contribute to deterioration of the renal function. Some centres perform kidney biopsies after completion of treatment for an episode of LN as a part of the treatment evaluation. The term "repeat biopsy" is often used to describe these biopsies. Several studies have reported that repeat kidney biopsies show activity at the level of tissue, even in patients with normal routine blood and urine markers. The investigators strongly believe that this information is important, and should be taken into consideration during decision of treatment. To provide evidence for this, the investigators have designed a collaborative project within the frame of the Lupus Nephritis Trials Network. With this research project, the investigators want to contribute to an increased proportion of patients with LN who achieve remission (inactivity) of LN, and a reduced proportion of patients who worsen in renal function in the long term. Patients with SLE who develop a first episode of LN will be asked to participate in this project, and will receive treatment according to current guidelines. Half of the patients will undergo a repeat biopsy 12 months later, and half of the patients will not. The selection of patients who will undergo or not undergo repeat biopsy will be random. Patients with high disease activity at the level of kidney tissue will receive more intense immunosuppressive treatment. Patients who have not undergone repeat biopsy will continue to be treated according to standard routine. The investigators will compare the results of treatment between the group of patients who underwent and the group of patients who did not undergo repeat biopsy, with regard to (i) complete disease inactivity at month 24 and (ii) renal function at month 60 from treatment initiation. The investigators expect that significantly greater proportions of patients in the repeat biopsy group will have inactive disease at month 24 and adequate levels of renal function at month 60. This will provide support for performing repeat biopsies as a part of the treatment evaluation, in order to optimise the therapeutic management and improve the long-term prognosis of patients with LN.

NCT ID: NCT04448639 Recruiting - Myocardial Stunning Clinical Trials

Stunning in Takotsubo Versus Acute Myocardial Infarction

STAMI
Start date: December 12, 2019
Phase:
Study type: Observational

The Stunning in Takotsubo versus Acute Myocardial Infarction (STAMI) Study Background: Acute myocardial stunning, herein defined as the reversible loss of myocardial function, occurs in both takotsubo syndrome (TS) and ST-elevation myocardial infarction (STEMI), and can be life-threatening in both conditions. However, despite typically having considerably more pronounced myocardial stunning, TS patients have better prognosis than patients with STEMI. Despite the different relationship between extent of myocardial stunning and prognosis in TS vs STEMI, no 'head-to-head' comparison of the myocardial stunning phenotypes in TS vs STEMI has been done. Methods: The Stunning In Takotsubo and Acute Myocardial Infarction (STAMI) study is a single-center, prospective clinical study that will enroll 100 patients with STEMI and 25 patients with TS. Echocardiography, laboratory testing (including troponin and NTpro-BNP), and ECG will be done immediately after angiography and at days 1, 2, 3, 7, 14 and 30. The primary endpoint is the proportion of myocardial stunning that has resolved after 72 hours, as determined by echocardiography. Total myocardial stunning is defined as the extent of akinesia observed at day 0 that resolves by day 30.

NCT ID: NCT04445571 Recruiting - Analgesia Clinical Trials

Surfactant Administration by Insure or Thin Catheter

SAINT
Start date: May 21, 2021
Phase: N/A
Study type: Interventional

This trial evaluates the efficacy and safety of surfactant administration with thin catheter technique together with analgesic premedication in comparison with the established INSURE-strategy. It will provide valuable knowledge to improve clinical methodology and enhance lung protective treatment strategies for preterm infants.