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NCT ID: NCT04982393 Recruiting - Clinical trials for Primary Hyperoxaluria Type 1

BONAPH1DE, A Prospective Observational Study of Patients With Primary Hyperoxaluria Type 1 (PH1)

BONAPH1DE
Start date: December 13, 2021
Phase:
Study type: Observational

The purpose of this study is to describe the natural history and progression of patients diagnosed with PH1, and to characterize the long-term real-world safety and effectiveness of lumasiran.

NCT ID: NCT04980638 Recruiting - Clinical trials for X-Linked Hypohidrotic Ectodermal Dysplasia (XLHED)

Intraamniotic Administrations of ER004 to Male Subjects With X-linked Hypohidrotic Ectodermal Dysplasia

EDELIFE
Start date: April 26, 2022
Phase: Phase 2
Study type: Interventional

This is an open-label, prospective, genotype-match controlled for primary estimand, non randomized, multicenter, international Phase 2 clinical trial designed to investigate the efficacy and safety of ER004 administered intraamniotically as a treatment for unborn XLHED male subjects.

NCT ID: NCT04979741 Recruiting - Clinical trials for Intensive Care Unit Syndrome

Recovery After Intensive Care Study

RAI
Start date: January 1, 2021
Phase:
Study type: Observational

Post-ICU long term sequelae- defined as "post intensive care syndrome" (PICS) manifest with a wide spectrum of psychological and cognitive impairments, affecting over two-thirds of ICU survivors and leading to increased rehospitalization, health care costs, impaired quality of life (QoL), inability to return to work and burden for families. The prevalence of post-traumatic stress symptoms (PTSD), anxiety symptoms, and depression after ICU stay is high and has been demonstrated in up to 50% of post-ICU population. Therefore, over the last years, an important effort has been made for the development of ICU aftercare and follow-up clinics with the aim to detect and to minimize post-ICU sequelae and improve outcomes. However, the utility of these follow-up programs and their effect on outcome has not been completely demonstrated.

NCT ID: NCT04979468 Recruiting - HIV-1-infection Clinical Trials

Early DOlutegravir/LAmivudine Switching After Virological Suppression (EDOLAS Study)

EDOLAS
Start date: March 23, 2021
Phase: Phase 3
Study type: Interventional

Phase III, randomized, open-label, multicentre, active-controlled, non-inferiority study evaluating the efficacy and safety of early switching to dolutegravir/lamivudine (DTG/3TC) in single-pill, in HIV-1 infected individuals currently taking an INSTI-based three-drug first-line regimen for less than 18 months and who have been virologically suppressed with HIV-1 RNA <50 copies/mL

NCT ID: NCT04977609 Recruiting - Hemiparesis Clinical Trials

A Music-based VR Intervention for Upper Limb Motor Rehabilitation in Hemiparetic Patients

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

Hemiparesis affects the majority of stroke patients in the acute phase. In post-stroke motor rehabilitation patients can re-learn motor sequences through repetitive training. Research showed that virtual reality (VR) can be effectively used in upper limb motor rehabilitation by training motor coordination and gestures in an immersive virtual environment. Another promising line of intervention in post-stroke rehabilitation is the use of music, with evidence supporting the notion that a rhythmic accompaniment promotes the recovery of motor coordination in patients with hemiparetic stroke. Furthermore, studies showed a beneficial effect of the observation of movements performed by a third person in patients with post-stroke hemiparesis. Based this evidence, the present study aims at testing the feasibility and efficacy of a novel music-based VR intervention designed for upper limb motor rehabilitation in post-stroke hemiparetic patients. The treatment consists in upper limb repetitive training activities through the imitation of movements synchronized with a musical accompaniment and is delivered in 10 sessions over 2 weeks, supervised by a physical therapist. Participants wear a VR headset through which they observe egocentric 180° 3D videoclips. The experimental condition (group A) will be compared with a no-music condition (group B), to test the specific effect of music, and with traditional physiotherapy rehabilitation (group C), to test the efficacy of the approach. The investigators expect that the patients undergoing the experimental intervention (group A and group B) will show a greater upper limb motor function improvement, as compared to the active control group. As a secondary endpoint the investigators expect the music component to induce a greater motor improvement as compared to the experimental condition without music.

NCT ID: NCT04976712 Recruiting - Clinical trials for Out-Of-Hospital Cardiac Arrest

Core Temperature in Patients With OHCA

CT-OCHA
Start date: July 1, 2021
Phase:
Study type: Observational

A prospective observational study aiming to monitor core temperature via an esophageal probe in out of hospital cardiac arrest during transport and until arrival in hospital. Insertion of an esophageal temperature probe will be done on scene during ongoing resuscitation manoeuvres based on European Resuscitation Council Guidelines 2015 (or newer). Environmental temperature influence and hypothermia prevention interventions will be monitored.

NCT ID: NCT04976205 Recruiting - Clinical trials for Hematological Disease

AI Algorithms to Automate the TMI by VMAT Optimization Using WB-CT/MRI and Synthetic WB-CT - The AuToMI Project

AuToMI
Start date: June 15, 2021
Phase: N/A
Study type: Interventional

Total Body Irradiation (TBI) was shown to help in providing immunosuppression that facilitates the donor transplant acceptance. Randomized trials demonstrated that conditioning regimens to bone marrow transplantation (BMT) including TBI have produced better survival rates than chemo-only regimens. The TBI target is represented by the whole BM, and eventually the whole lymphatic system, liver, spleen. The increased life expectancy revealed the occurrence of important toxicities because of full doses received by organs at risk (OARs) and this limited the use of TBI. Many groups have explored the possibility of sophisticated techniques for reducing the dose to healthy tissues while increasing the dose to the BM. These newer approaches aim to generate total marrow (lymph-node) irradiation (TMI/TMLI), sparing as much as possible non-skeletal and non-lymphoid structures. Actually, the time required to optimize a TMI/TMLI plan is 10 days. Therefore, the simulation Computed Tomography (CT) is performed many days before the BMT. Furthermore, the lymph-nodes are defined only on CT images.

NCT ID: NCT04976153 Recruiting - Fecal Incontinence Clinical Trials

Skeletal Muscle-derived Cell Implantation for Treatment of Fecal Incontinence

Fidelia
Start date: May 11, 2022
Phase: Phase 3
Study type: Interventional

The objective of this study is the final assessment of clinical safety and efficacy of autologous autologous skeletal muscle derived cells for patients with urge fecal incontinence due to external anal sphincter dysfunction caused by its disruption and/or weakness.

NCT ID: NCT04975997 Recruiting - Multiple Myeloma Clinical Trials

Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

EXCALIBER-RRMM
Start date: June 23, 2022
Phase: Phase 3
Study type: Interventional

This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).

NCT ID: NCT04975724 Recruiting - Clinical trials for Major Depressive Disorder

Safety of Liposom With Citalopram in Elderly Patients With Major Depressive Disorder

Start date: April 18, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine if Liposom Forte will enhance the response to antidepressant therapy with citalopram in elderly patients suffering from Major Depressive Disorder (MDD).