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NCT ID: NCT04679454 Recruiting - Breast Cancer Clinical Trials

Single Fraction Preoperative Radiotherapy for Early Stage Breast Cancer

Start date: July 31, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/II, single-arm and open-label single-centre clinical trial with the aim to test the feasibility, safety and the efficacy, in terms of complete pathological response, of preoperative ablative radiotherapy in single fraction for selected breast cancer patients.

NCT ID: NCT04679064 Recruiting - Ovarian Cancer Clinical Trials

Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment

NItCHE-MITO33
Start date: December 1, 2020
Phase: Phase 3
Study type: Interventional

Randomized phase 3 trial evaluating niraparib plus dostarlimab vs chemotherapy at physician's choice in the treatment of recurrent ovarian, fallopian tube or primary peritoneal cancer patients for which platinum is not an option

NCT ID: NCT04678804 Recruiting - Gingival Diseases Clinical Trials

Connective Tissue Graft Versus Collagen Matrix.

Start date: January 20, 2021
Phase: Phase 4
Study type: Interventional

Despite the potential role of soft tissue thickness in maintaining gingival margin stability, the existing literature has mainly focused on investigating the effect of different surgical techniques on recession coverage percentage, without taking into account the changes in tissue thickness and biotype in the surgical area. Hence, this study aims to compare threedimensional scans of gingival recessions treated either with CAF+CTG or with CAF+PDCM by the use of a dedicated superimposition software at different healing timepoints. The primary outcome is to assess the change in mm3 and the distribution pattern of soft tissue thickening in the surgical area between autologous and heterologous grafts at 1, 3, and 6 months post-surgery. The secondary outcomes are: the complete root coverage at 6 months post surgery and Patients' Reported Outcomes (PROMS) measured with oral impact on daily performances (OIDP questionnaire) and on the evaluation of patients' perception about therapy.

NCT ID: NCT04677608 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

Pulmonary Hypertension Modality of Death and Validation of REVEAL Risk Score

ASPYRE-1
Start date: July 21, 2020
Phase:
Study type: Observational

Pulmonary Arterial Hypertension (PAH) is a chronic disease characterized by a progressive increase in pulmonary vascular resistance (PVR), which leads to right ventricular (RV) failure, and ultimately death. Different studies have outlined how various factors as vascular resistance, functional class, age, correlate with mortality. However, the modality of death and risk factors for mortality in patients with PAH are little known. For this purpose, more studies are necessary to analyze the risk factors related to modality of death in PAH.

NCT ID: NCT04677569 Recruiting - Clinical trials for Mycobacterium Infections, Nontuberculous

Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

ENCORE
Start date: April 1, 2021
Phase: Phase 3
Study type: Interventional

The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin [AZI] + ethambutol [ETH]) compared to the ELC (empty liposome control) + background regimen on participant-reported respiratory symptoms at Month 13.

NCT ID: NCT04677400 Recruiting - Body Image Clinical Trials

More Than Body Appearance (MBA) Intervention

Start date: November 16, 2020
Phase: N/A
Study type: Interventional

The link between sport, physical exercise, and body image depends on the reasons underlying an individual's desire to engage in sport and physical exercise. Individuals characterized by reasons for exercise related to physical appearance are likely to focus on factors such as the number of calories burned, reductions in body weight, or visible changes in physical appearance during the practice; in accordance, appearance-related reasons for exercise are associated with body dissatisfaction and disordered eating. In contrast, reasons to exercise unrelated to physical appearance (such as health and enjoyment) are associated with body satisfaction. Thus, only certain reasons for exercise are associated with positive body image outcomes. Recently, literature studies affirmed that experimental designs could manipulate the emphasis placed on function (as opposed to physical appearance) during sport practice and physical exercise to promote positive body image. Based on this evidence, the first objective of the study will be testing the effectiveness of a psychological online intervention (More than Body Appearance [MBA] intervention) targeting body image in improving body image in individuals practicing physical activity.

NCT ID: NCT04676347 Recruiting - Evaluation Clinical Trials

Health-care Quality in Semi-intensive Care Units

Start date: July 1, 2021
Phase:
Study type: Observational

The main aim of this study is to realize a system of continuous evaluation of healthcare quality in semi-intensive care units.

NCT ID: NCT04674683 Recruiting - Clinical trials for Unresectable or Metastatic Melanoma

Study Comparing Investigational Drug HBI-8000 Combined With Nivolumab vs. Nivolumab in Patients With Advanced Melanoma

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

This is a phase 3 study to compare the efficacy and safety of HBI-8000 or Placebo combined with nivolumab on patients with unresectable or metastatic melanoma and eligible patients who are not adolescents or patients with new, progressive brain metastasis will be stratified by PD-L1 expression and LDH level.

NCT ID: NCT04673240 Recruiting - Multiple Sclerosis Clinical Trials

CLINICAL EFFECT OF BOTULINUM TOXIN TYPE A IN TREATMENT OF SPASTICITY

Start date: March 29, 2019
Phase:
Study type: Observational

Spasticity has been defined as a disorder of the sensorimotor system characterized by a velocity-dependent increase in tonic stretch reflexes (muscle tone) with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex. The treatment goal of spasticity is Medical treatment generally combines physiotherapy with medications, depending on spasticity distribution. Systemic treatments such as oral or intrathecal baclofen are generally considered in case of generalized spasticity, whereas local treatments are considered in case of focal spasticity. Local treatments such as Botulinum Toxin type A, phenol, and alcohol present several advantages, allowing to treat of selected muscles without the risk of sedation. As stated above, they are indicated for focal spasticity but might be helpful even in the presence of generalized spasticity with identified focal goals (Bethoux et al., 2015). In particular, Botulinum Toxin type A (BoNT-A) is considered the gold standard treatment for focal spasticity, showing a level A evidence for spasticity reduction in upper- and lower-limb spasticity (Simpson et al., 2016). However, current evidence is mainly focused on post-stroke spasticity (Franceschini et al., 2014), whereas it is still limited in spasticity as a consequence of other aetiologies, such as spinal cord injury (SCI), traumatic brain injury (TBI), or multiple sclerosis (MS). Interestingly, spasticity is a major concern for the rehabilitation of these patients. The aim of this observational study is the evaluation of the clinical efficacy of BoNT-A in spasticity reduction in patients affected by neurological conditions different from post-stroke spasticity, such as SCI, TBI, and MS.

NCT ID: NCT04673032 Recruiting - Pain, Chronic Clinical Trials

Radiofrequency (RF) Ablation Prospective Outcomes Study

RAPID
Start date: December 22, 2020
Phase:
Study type: Observational [Patient Registry]

The objective of this study is to compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems in the treatment of patients diagnosed with pain and in use for central nervous system (CNS) applications for other disorders.