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NCT ID: NCT04657822 Recruiting - Sickle Cell Disease Clinical Trials

Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study

Start date: June 10, 2021
Phase: Phase 4
Study type: Interventional

This is a multi-center multi-national rollover study to allow continued access to crizanlizumab for patients with sickle cell disease (SCD) who are on crizanlizumab treatment in a Novartis-sponsored study (parent study) and are benefiting from the treatment as judged by the investigator.

NCT ID: NCT04657510 Recruiting - Covid19 Clinical Trials

Femoral frACturEs and COVID-19.

FACE COVID-19
Start date: November 14, 2020
Phase:
Study type: Observational

Retrospective cohort study comparing the early prognosis after surgically-treated proximal femur fragility fractures in patients affected and not affected by COVID-19.

NCT ID: NCT04657289 Recruiting - Clinical trials for Neovascular Age-related Macular Degeneration (nAMD)

A Study of the Efficacy, Safety, and Pharmacokinetics of A 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Velodrome)

Start date: July 14, 2021
Phase: Phase 3
Study type: Interventional

Study WR42221 is a Phase IIIb, global, multicenter, randomized, visual assessor-masked study designed to assess the efficacy, safety, and pharmacokinetics of the Port Delivery System with ranibizumab (PDS) 100 mg/mL delivered every 36 weeks (Q36W) compared with every 24 weeks (Q24W) in patients with neovascular age-related macular degeneration (nAMD).

NCT ID: NCT04657120 Recruiting - Cancer Clinical Trials

Safety and Efficiency of the YEARS Algorithm Versus Computed Tomography Pulmonary Angiography Alone for Suspected Pulmonary Embolism in Patients With Malignancy

HYDRA
Start date: June 1, 2019
Phase: N/A
Study type: Interventional

The aim of this study is to prospectively validate the safety and efficiency of management according to the YEARS algorithm to safely rule out clinically suspected PE in patients with active malignancy to be compared with 'standard' management by computed tomography pulmonary angiography (CTPA) alone in a randomized study.

NCT ID: NCT04656483 Recruiting - Clinical trials for Neurodevelopmental Disorders

Supporting Parenting at Home: Empowering Rehabilitation Through Engagement (SPHERE)

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

Infants with Neurodevelopmental Disabilities (ND) show emotional, cognitive and socio-interactive dysregulation dramatically impacting on caregiving behavior. Early family-centered rehabilitation interventions are effective in promoting better infant outcomes and in optimizing healthcare systems economic return in the long-term. The Video Feedback intervention (VFI) is effective in promoting sensitive parenting and supporting infants' development. In the light of limited resources of the healthcare systems, technological advance in telemedicine may facilitate the delivery of VFI to a greater number of families of infants with ND. Consistently, the Supporting Parenting at Home: Empowering Rehabilitation through Engagement (SPHERE) project is a randomized controlled trial (RCT) aiming at assessing effectiveness and efficacy of an early family centered VFI parenting support delivered through videoconferencing on dyads with infants with ND.

NCT ID: NCT04656262 Recruiting - Clinical trials for Soft Tissue Sarcoma Adult

Low Dose Continuous Cyclophosphamide vs Standard Doxorubicin in Advanced Sarcoma Elderly Patients

METROPHOLYS
Start date: September 10, 2018
Phase: Phase 3
Study type: Interventional

To compare the efficacy, as measured by time to treatment failure, of metronomic cyclophosphamide with respect to doxorubicin in elderly patients affected by mSTS.

NCT ID: NCT04655495 Recruiting - Celiac Disease Clinical Trials

Impact of a Low-FODMAP Gluten-free Diet on Gut Microbiota and Circulating miRNAs in Celiac Disease Patients

FODMAP2019
Start date: February 6, 2022
Phase: N/A
Study type: Interventional

15 patients with refractory celiac disease (RCD) and 15 patients with CD responsive to the GFD between the ages of 21 and 60 will be enrolled. The aim of the research will be: 1) to characterize the intestinal, blood and duodenal microbiota, then to evaluate both the taxonomy of the identified bacteria and their relative abundance 2) to analyse the profile of miRNAs from biopsy and fibroblasts isolated in the first duodenal portion, highlighting any basal deregulation and, for fibroblasts, after treatment with the 33-mer immunogenic peptide 3) quantify and know the composition of the fecal microbiota in celiac patients with persistent symptoms and in refractory celiac patients before (T0) and after (T28) treatment with a low-FODMAP diet. The aim of the study is to observe a diversification of the microbiota pattern of refractory patients vs. normoresponsive celiac patients and to observe a deregulation in the expression of miRNAs, both basally on biopsies and after treatment with the immunogenic peptide in primary fibroblast cultures.

NCT ID: NCT04655118 Recruiting - Myelofibrosis Clinical Trials

Study of TL-895 in Subjects With Myelofibrosis or Indolent Systemic Mastocytosis

Start date: October 22, 2020
Phase: Phase 2
Study type: Interventional

This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis (Cohorts 1-3) or Indolent Systemic Mastocytosis (Cohort 5). Participants must be diagnosed with Myelofibrosis and be relapsed/refractory (e.g., having failed prior therapy), intolerant, or ineligible to receive JAKi treatment, or be diagnosed with Indolent Systemic Mastocytosis.

NCT ID: NCT04654741 Recruiting - Infertility Clinical Trials

The Rate of Embryo Euploidy in Progestin-primed Ovarian Stimulation Cycles

PPOS
Start date: September 1, 2020
Phase: Phase 4
Study type: Interventional

The main objective of this non-inferiority randomized controlled trial is to assess the rate of blastocyst euploidy and the number of euploid blastocysts in women undergoing IVF/ICSI and treated with PPOS versus conventional ovarian stimulation based on the use of GnRH antagonist The hypothesis is that PPOS is associated with a rate of blastocyst euploidy similar to what found with the conventional ovarian stimulation. In other words, the number of euploid blastocysts that can be obtained with the PPOS strategy is expected to be the same obtained with conventional ovarian stimulation. Moreover we expect to find non significant differences in all intermediate outcome of the IVF cycles, such as in the rate of premature LH surge, in the rate of patients with elevation of Progesterone on the triggering day, in FSH consumption and length of stimulation, in the rate of poor response and hyperresponse, in number of retrieved and mature oocytes, in fertilization and blastulation rate, in the number of available blastocysts and in the morphological quality of blastocysts

NCT ID: NCT04654494 Recruiting - Colorectal Cancer Clinical Trials

Colorectal Cancer in Crohn's Disease

Start date: July 1, 2020
Phase:
Study type: Observational

Retrospective multicentre study. All patients with a diagnosis of Crohn's disease (CD) and operated for colorectal cancer (CRC) between 01/01/2010 and 01/01/2020 will be included in the dataset. Data will include preoperative, intraoperative and postoperative variables, with long term follow up when feasible. The study will focus on a comparison between patients treated with total proctocolectomy (TPC) and patients treated with subtotal colectomy (STC) or segmental resection (SR). Primary endpoints will be oncologic outcomes, postoperative morbidity and mortality. Secondary endpoints include quality of life (QoL).