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NCT ID: NCT04469985 Completed - Clinical trials for Allogeneic Stem Cell Transplantation in Elderly Patients

Allogeneic Stem Cell Transplantation (ALLO-SCT) in Elderly: 17-years Retrospective GITMO Survey

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

The age of patients' population is increasing every year, as the life expectancy. Thus, the incidence and prevalence of hematological cancers is increasing. In particular, acute leukemias and myelodisplastic syndromes are the most frequent diseases of the hematopoietic system. Allogeneic stem cell transplantation (allo-SCT) is the main therapeutic options for these diseases, and the number of allo-SCTs in the elderly is currently in progressive growth. This is partially due to the improvement of the allo-SCT procedure over the years, with the amelioration of donor selection, HLA typing, graft versus host disease (GVHD) and infections prophylaxis and treatment. Nevertheless, there is still an unmet clinical need, represented by the lack of extensively and detailed outcome analysis of elderly patients addressed to allo-SCT. With this aim, we planned this retrospective analysis of allo-SCTs in patients older than 60 years, within the GITMO transplant activity of the last 17 years. This study will help us in designing future prospective trials, including a comprehensive geriatric assessment of frailty, in order to address to allo-SCT those elderly who have the highest probability to achieve the best long term outcome with the lowest transplant-related mortality and morbidity.

NCT ID: NCT04469946 Completed - Hearing Impairment Clinical Trials

Hearing Aid Noise Reduction in Pediatric Users Pilot Study (Oticon Pilot Study)

Start date: March 5, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy of OpenSound Navigator (OSN), a hearing aid speech-enhancement algorithm developed by Oticon, as treatment for pediatric hearing aid users. The study used a within-subjects design with pre- and post-comparisons involving fifteen pediatric (ages 6-12) patients with symmetrical sensorineural hearing losses ranging from the mild to moderately-severe degree. All participants were fit with bilateral Oticon OPN™ behind-the-ear hearing aids set with the OSN algorithm enabled. The investigators evaluated hearing aid benefit through word recognition in noise (behavioral testing) and everyday hearing/listening abilities (parental/legal guardian reported) within one week of the hearing aid fitting (pre-intervention) and two months post fitting (post-intervention).

NCT ID: NCT04469465 Completed - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

Danicopan as Add-on Therapy to a C5 Inhibitor in Paroxysmal Nocturnal Hemoglobinuria (PNH) Participants Who Have Clinically Evident Extravascular Hemolysis (EVH)(ALPHA)

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

The main objective of this study is to evaluate the efficacy of danicopan as add-on therapy to a complement component 5 (C5) inhibitor (eculizumab or ravulizumab) in participants with PNH who have clinically evident EVH.

NCT ID: NCT04469413 Completed - Clinical trials for Patent Ductus Arteriosus in Preterm Infants

Comparison of Infusion Paracetamol Protocols in PDA

Start date: January 1, 2019
Phase:
Study type: Observational

The aim of this study was to evaluate the effect of paracetamol on patent ductus arteriosus (PDA) closure and clinical outcomes in preterm infants when used as standard intermittent bolus and continuous intravenous (IV) infusion. Preterm neonates with birth weight (BW) ≤1500 g and gestational age (GA) ≤32 weeks were included in this study. During the study period, IV paracetamol therapy was given to all infants with hemodynamically significant patent ductus arteriosus (hsPDA). The patients were divided into the standard IV intermittent bolus infusion group and the continuous IV infusion group.

NCT ID: NCT04469244 Completed - Clinical trials for Study on the Use of Radiomics in Gliomas of Initial Disgnosis

Evaluation of the Use of Radiomics in 18F-FDOPA PET Examinations for the Characterization of Gliomas

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

The evaluation of gliomas in imaging represents a real challenge today, at the initial diagnosis, for therapeutic planning or follow-up treatment of these lesions. There is an urgent need for non-invasive imaging tools to evaluate a glioma throughout its management. At present, the diagnosis of certainty is only obtained through an anatomo-pathological analysis with sampling during an invasive procedure (surgery or biopsy). Magnetic resonance imaging, through perfusion, diffusion imaging or spectroscopy is developing in gliomas. However, it remains time-consuming and is not always available. At the same time, positron emission tomography (PET) with amino acids is an interesting alternative for these brain tumours. Amino acid PET has the advantage of being more specific than the abnormalities detected in MRI and the amino acid radiotracers cross the blood-brain barrier, even if not broken, unlike Gadolinium in MRI. Among these radiotracers, 18F-FDOPA can, among other things, assist in the non-invasive staging of gliomas at initial diagnosis.

NCT ID: NCT04469218 Completed - Clinical trials for IV Catheter-Related Infection or Complication

A Clinical Trial Using a New Medical Device to Evaluate Its Impact on IV Care and Clinical Complications

DIPPER
Start date: July 14, 2020
Phase: N/A
Study type: Interventional

A clinical trial comparing two groups of patients that are randomized into one group having SafeBreak Vascular attached to their peripheral IV lines and a second control group that receives the current standard of care (no SafeBreak Vascular) to determine SafeBreak Vascular's impact on IV clinical care and complications.

NCT ID: NCT04469166 Completed - Clinical trials for Use of Tourniquet in Total Knee Arthroplasty

Effects of the Use of Tourniquet in Total Knee Arthroplasty on the Clinical and Functional Outcomes With 5 Years of Follow up

Start date: March 1, 2014
Phase: N/A
Study type: Interventional

This study is randomized controlled trial with 5 years follow up and involved 101 patients divided in two groups; group A in which tourniquet was used in total knee arthroplasty while group B in which tourniquet was not used. All these patients were analyzed for the clinical and functional outcome measures.

NCT ID: NCT04469088 Completed - Clinical trials for Temporomandibular Joint Disorders

Effectiveness of Dry Needling vs Manual Therapy in Patients With Temporomandibular Joint Disorders.

Start date: August 11, 2020
Phase: N/A
Study type: Interventional

Temporomandibular Joint Disorders (TJD) represent a set of conditions that involve pain and dysfunction of the temporomandibular joint. TJD are a frequent disability affection in the worldwide population and the 35% of affected present at least a symptom such as orofacial pain, mouth movement limitations and snapping or crying temporo-mandibular. Due to the increase of the incidence of the TJD the investigators propose to complete this study. A randomized controlled trial with parallel groups have been designed and blind evaluation of the response variable. The hypothesis is that dry needling produces a positive effect in the involved variables of this study in comparison with manual therapy. The aim of this RCT is to compare the effectiviness of the application of manual therapy in comparison with dry needling in the perceived pain, mouth opening, the degree of cervical disability and the pressure-pain threshold (PPT) of myofascial trigger points (MTrP) in patiens with TJD.

NCT ID: NCT04468620 Completed - Clinical trials for Autism Spectrum Disorder High-Functioning

A Peer-mediated Vocational Social Skills Program for Young Adults With Autism

Start date: September 16, 2019
Phase: N/A
Study type: Interventional

The Assistive Social Skills and Employment Training program (ASSET) is an occupationally-based, work-related social skills intervention, designed to address the pre-employment and mental health needs of young adults with high-functioning autism in school-to-work transition. Knowing that occupational therapy (OT) services designed to address the post-secondary transition needs of this population have been largely unexplored, and recognizing the need for OT students to gain practical experience facilitating psychosocial groups, this study seeks to: (1) evaluate program impacts on participants' psychosocial functioning and work readiness, and (2) pilot the use of OT students as group facilitators. The study will follow a mixed-methods, single group design, using questionnaires and interviews to assess skills, confidence, and psychological wellness before intervention, immediately after, and at follow-up. OT students will also be interviewed and complete pre- and post-intervention assessments of clinical self-efficacy and stress. This project supports the AOTF's objectives by: (1) building OT academic program capacity to partner with university services and the autism community to improve transition outcomes in an underserved group, (2) laying the groundwork for larger, more rigorous studies of ASSET's effectiveness, and (3) gathering pilot data to support future grant applications at the federal level.

NCT ID: NCT04468386 Completed - Clinical trials for Focus in on Collecting Paired Specimens for Matrix Equivalency

Specimen Collection Study Protocol

Start date: July 7, 2020
Phase:
Study type: Observational

The specimens collected will be used to evaluate matrix equivalency in an immunoassay in development for the detection of IgG or IgA or IgM antibodies to SARS - CoV2 in human serum. These reagents are for in vitro diagnostic use only.