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NCT ID: NCT05442008 Completed - Migraine Clinical Trials

Predictive Role of MIDAS Reduction at 3 Months for Erenumab Treatment

Ere-MIDAS
Start date: December 1, 2018
Phase:
Study type: Observational

In 2021, the Italian Medicines Agency approved reimbursement of monoclonal antibodies targeting the CGRP pathway (CGRP-mAbs) as preventive therapies for patients with high frequency and chronic migraine (CM). A moderate to severe disability, quantified as a MIgraine Disability ASsessment (MIDAS) score > or equal to 11, is required for prescription. Score reduction of at least 50% after the first three months (T3) is mandatory to continue treatment. This is a prospective real-life, open-label study. CM patients will be treated with erenumab 70-140 mg subcutaneous injections every 28 days for one year (T13). We will record the following parameters: demographic and headache features, monthly migraine and headache days (MMDs and MHDs respectively), days and doses of symptomatic intake. Patients also completed questionnaires evaluating migraine related disability (MIDAS and HIT-6), psychological comorbidities (HADS-A and HADS-D), quality of life (MSQ and 0 to 100 visual analogue scale) and allodynia (ASC-12). At least a 50% reduction in MIDAS score or MMDs after 3 months of treatment will be testedas predictors of long-term clinical outcome.

NCT ID: NCT05441241 Not yet recruiting - Procedural Pain Clinical Trials

Leap Motion Controller for Pain During Venipuncture in Pediatrics. Randomized Controlled Trial

LeapRCT
Start date: July 1, 2022
Phase: N/A
Study type: Interventional

Venipuncture is the most frequent invasive procedure in hospitals and clinics. In the pediatric population this is very often associated with fear, anxiety, distress and enhanced perception of pain. It is well known that we can use local anaesthetic creams (like EMLA) to reduce pain and therefore distress but they need 30-60 minutes of waiting between the application and the puncture, which is too much time for most of everyday life clinical contests, for instance in the emergency department. Many distraction techniques have been studied: active- (video games, virtual reality, interactive games…) and passive ones (listening to music, visual stimulation, lecture…), some of them with a high-tech device, others with a low-tech device, but the quality of most of these trials is quite low. It is useful to have studies in which traditional distraction techniques are compared with experimental techniques, while keeping in mind the practicality of them in real contests. Active production of music, both in a musician and in a non-musician, is one of the most complex activities for our central nervous system. It requires a precise timing of a lot of well coordinated actions, like recognition and conservation of a rhythmic structure, precise execution of quick and complex fine movements, and with an important involvement of intense emotional experience. In fact it stimulates bilaterally primary and secondary auditory cerebral areas, but also motor and premotor areas, language areas and their controlateral, cognitive areas. At the same time it activates reward and gratification circuits with stimulation of the limbic system and endorphin release and also neurovegetative system. Music is probably the most immediate and spontaneous communication tool that can also act at subcortical level without the person being aware of what they are receiving and transmitting. In particular music activates the dopaminergic mesolimbic system, which regulates memory, attention, executive functions, motivation and also mood and pleasure through the nucleus accumbens. It also produces measurable cardiovascular and endocrine responses indicated by reduced serum cortisol levels and inhibition of cardiovascular stress reactions. The experimental technique we suggest uses the Leap Motion Controller, that is, an infrared device that digitalizes the movements of the hand above it in real-time: this is connected with a software that converts this signal into a musical tone specifically set. The melody is created very easily just by moving the hand above it. With this device, children will be able to produce music without anything interposing between them and the sound production. This will allow the patient to focus only on the melodies, without technical difficulties that could derive for instance from a visual interface or an instrument you have to hold.

NCT ID: NCT05440864 Not yet recruiting - Clinical trials for Hepatocellular Carcinoma

Durvalumab and Tremelimumab in Resectable HCC

(NEOTOMA)
Start date: July 2022
Phase: Phase 2
Study type: Interventional

Hepatocellular Carcinoma (HCC) is the third most common cause of death from cancer world wide and the incidence is rising globally. Despite surgical resection in appropriate patients, many patients recur. The results of the IMbrave150 study have established PD-L1 inhibition in combination with VEGF inhibition as a new standard of care highlighting the role of immune checkpoint inhibition in advanced HCC. In addition, the combination of Tremelimumab and Durvalumab has demonstrated efficacy in advanced HCC; the HIMALAYA trial has now completed accrual in treatment naïve patients with advanced HCC. Furthermore the earlier use of immune checkpoint inhibitors in this disease are being explored with adjuvant combination strategies, including the EMERALD-2 trial (NCT03847428). Neoadjuvant treatment in HCC allows for delivery of treatment pre surgery and may enhance pathological responses and improve outcomes. The delivery of combination CTLA-4 and PD-L1 inhibition has demonstrated efficacy in other tumour types in the neoadjuvant setting where the impact on the tumour microenvironment has also been evaluated. The safety and feasibility of Durvalumab and Tremelimumab in resectable HCC has yet to be established. Hypotheses Pre-operative (pre-op) Durvalumab and Tremelimumab treatment is safe and feasible in pre surgical setting for upfront resectable HCC The combination of Durvalumab and Tremelimumab pre-op will result in changes in immune and molecular characteristics within the tumour microenvironment. Overall Study Design This is a phase II, open-label multi-centre study to assess safety of Durvalumab and Tremelimumab treatment in pre-op setting for upfront resectable HCC, followed by adjuvant Durvalumab. 28 patients are expected to enrol at three sites. Patients will receive pre-op: 1 dose Tremelimumab (300mg) (T300) with Durvalumab (1500mg) at cycle 1 and 1 further cycle of Durvalumab (1500mg) only. Post-surgical resection, adjuvant therapy will consist of Durvalumab Q4W for up to a maximum of 12 months in total or 13 cycles of Durvalumab (11 cycles post op). All participants will be treated until progressive disease or unacceptable toxicity or withdrawal of consent or another discontinuation criterion is met. All participants will be followed for survival until the end of study. No dose reductions of Tremelimumab and Durvalumab will be allowed. Statistics The primary objective of this study is to assess safety of pre-op treatment with Durvalumab and Tremelimumab. For safety, with the null proportion of patients who discontinue treatment due to AEs, imAEs or SAE is 30% versus the alternative proportion is 10% or less than 10%, a sample size of 28 provides 80% power to detect the proportion difference with a two-sided alpha level of 0.1. The sample size estimate is based on the two-sided exact test for binomial proportion considering Binomial Enumeration method.

NCT ID: NCT05440786 Not yet recruiting - Neoplasm Metastasis Clinical Trials

CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma

Start date: August 15, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to measure the benefit of adding abemaciclib to chemotherapy for Ewing's sarcoma that has come back or did not respond to treatment. This trial is part of the CAMPFIRE master protocol, which is a platform to speed development of new treatments for children and young adults with cancer. Your participation in this trial could last 11 months or longer, depending on how you and your tumor respond.

NCT ID: NCT05440682 Recruiting - Clinical trials for Traumatic Brain Injury

Connectivity in Cranioplasty

Start date: October 27, 2020
Phase: N/A
Study type: Interventional

An Exploratory Interventional study to assess the effects of cranioplasty on brain network connectivity, neuropsychological and motor functioning in patients with severe acquired brain injury with pre-, post-cranioplasty and 6 months follow-up assessments.

NCT ID: NCT05439382 Active, not recruiting - Surgery Clinical Trials

Analysis of Root Coverage Stability.

Start date: January 1987
Phase:
Study type: Observational

One-hundred and one healthy participants (221 gingival recessions-GRs) were treated from 1987 to 1996. The probing depth (PD), keratinized tissue width (KTW), gingival recession depth (RD), gingival recession width (RW), gingival recession area (RA) were evaluated and considered at baseline and along time. The obtained data will be evaluated and compared.

NCT ID: NCT05436977 Recruiting - Clinical trials for Coronary Artery Disease

Synergy Between morpHOlogical and inflammatoRy Evaluation in Predicting Long-term Coronary Plaque Progression

SHORE
Start date: June 21, 2021
Phase: N/A
Study type: Interventional

Data from human autopsy studies have showed that thrombosis of a ruptured plaque with a large necrotic core, inflammatory cells and a thin fibrous cap, the so-called thin cap fibroatheroma (TCFA), represents the main mechanism for acute coronary syndrome (ACS). Optical coherence tomography (OCT) is an imaging technique that provides high-resolution, cross-sectional images of tissue in situ. The resolution of OCT (10 um) is appropriate for measuring a cap thickness less than65 μm, and even the plaque macrophage density. 68Ga-DOTA-(Tyr3)-octreotate/NaI3-octreotide(68Ga-DOTA-TATE/NOC) Positron Emission Tomography (PET)/Computed Tomography coronary angiography (CTCA), targeting the somatostatin receptor subtype-2 selectively expressed by M1 macrophages may show coronary inflammation. The SHORE protocol aims at evaluating the synergy between OCT and 68Ga-DOTA-TATE/NOC in predicting coronary plaque progression as assessed by CTCA

NCT ID: NCT05436899 Recruiting - Clinical trials for Laparoscopic Surgery

A Pilot Study on Training Simulator Efficacy

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to plan an effective learning path in minimally invasive thoracic and general surgery with a virtual training simulator for trainees and to assess the improvement of residents' surgical skills by the introduction of this virtual training program.

NCT ID: NCT05436704 Active, not recruiting - Pancreatic Cancer Clinical Trials

Is One Pass Enough for the Diagnosis of the Pancreatic Masses During EUS-FNB?

ONE PASS
Start date: June 21, 2022
Phase:
Study type: Observational

Endoscopic ultrasonography (EUS) with tissue acquisition (TA) is nowadays a well-established technique for the sampling of solid lesions pancreatic and non-pancreatic lesions. Major complications after EUS-TA of solid masses are rare. Several studies have been published in the last recent years aimed to identify factors related to a non-diagnostic or false-negative EUS-FNA, and to improve its diagnostic yield using different needle gauge and different tissue acquisition technique as fanning technique, slow-pull stylet extraction or suction technique. To overcome this problem, new EUS-TA needles entered in clinical practice to obtain histological specimens increasing the accuracy of the EUS-TA. Preliminary result with these new needles, called EUS-fine needle biopsy (FNB) are promising with an accuracy rate more than 90%. Recently, Leungh et al. conducted an observational study to evaluate the role of macroscopic on-site evaluation (MOSE) on the diagnostic accuracy of 22G Franseen-tip needle. The study demonstrated that MOSE using the 22G Franseen tip needle could limit needle passes by accurately estimating histologic core fragments. However, the study limitations such as the small sample size and the lack of control group, hampered the value of the conclusions. So, nowadays, no definitive data regarding how many needle passes need to be performed with FNB needles, neither regarding the use of MOSE to evaluate the specimens obtained with FNB needle. The MOSE technique of the acquired tissue was proposed for the first time by Iwashita et al, using a 19G needle and is nowadays a well-established technique with high accuracy in the final diagnosis. The aim of our study is to evaluate if during EUS-FNB of pancreatic masses only one needle pass with MOSE evaluation can be satisfactory to obtain a correct diagnosis.

NCT ID: NCT05436639 Recruiting - Clinical trials for ACTH-Independent Cushing Syndrome

SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor

ACSPIRE
Start date: June 9, 2022
Phase: Phase 2
Study type: Interventional

This will be a randomized, double-blind study to evaluate the efficacy, safety, and pharmacological effect of SPI-62 in subjects with hypercortisolism related to a benign adrenal tumor.