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NCT ID: NCT04926727 Not yet recruiting - Clinical trials for Vomiting of Pregnancy

Prevalence And Burden Of Nausea And Vomiting In Pregnant Women

PURITY
Start date: October 4, 2021
Phase:
Study type: Observational

On February 25th, 2019, ITALFARMACO launched Nuperal® in Italy, an association of doxylamine succinate and pyridoxine hydrochloride authorized by AIFA for the symptomatic treatment of nausea and vomiting in pregnancy (NVP). This drug is also recommended as first choice drug therapy by the American College of Obstetricians and Gynecologists (ACOG) Guidelines and is supported by extensive international literature. Numerous epidemiological researches conducted in the US and Norway have highlighted the extent of vomiting and pregnant nausea. Unfortunately to date, there are no information on the prevalence of this phenomenon in Italy, on its impact on women's lives and on the interaction between woman and gynecologists. The research hypothesis of the present survey is that, using a representative sample of pregnant women in Italy, it will be possible to identify the prevalence and weight of nausea and vomiting symptoms during pregnancy in this country. The study is an open, non-comparative, multicenter survey and the aim is to evaluate the prevalence and weight that the symptoms of nausea and vomiting have in pregnant women in Italy. The study population will include 600 women found during weeks 18-22 of pregnancy who will arrive at the three sites or will contact the Investigators after the Ethics Committee (EC) approval.

NCT ID: NCT04925479 Recruiting - Clinical trials for Myeloid Leukemia, Philadelphia Positive

Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia

Start date: December 27, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this study is to support development of asciminib in the pediatric population (1 to <18 years) previously treated with one or more TKIs. Full extrapolation of the efficacy of asciminib from adult to pediatric patients will be conducted. Full extrapolation is based on the concept that CML in the pediatric population has the same pathogenesis, similar clinical characteristics and progression pattern as in adults.

NCT ID: NCT04925284 Recruiting - Pancreatic Cancer Clinical Trials

Study of XB002 in Subjects With Solid Tumors (JEWEL-101)

Start date: June 7, 2021
Phase: Phase 1
Study type: Interventional

This is a Phase 1, open-label, multicenter, dose-escalation and expansion study evaluating the safety, tolerability, PK, pharmacodynamics, and clinical antitumor activity of XB002 administered IV q3w alone and in combination with nivolumab to subjects with advanced solid tumors.

NCT ID: NCT04924920 Recruiting - Clinical trials for Hemodynamic Instability

Sigh35 and End-expiratory Occlusion Test (EEOT) for Assessing flUid Responsiveness in Critically Ill Patients Undergoing Pressure Support Ventilation

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

The application of a brief SIGH of 4 seconds at 35 cmH20 has shown to reliably predict fluid responsiveness in critically ill patients undergoing pressure support ventilation. The end-expiratory occlusion test (EEOT) has been also used in the same type of patients, with the same purpose, but in a limited amount of studies. The aim of this study is to compare the reliability of the the two test in assessing fluid responsiveness.

NCT ID: NCT04924608 Active, not recruiting - Neurofibromatosis 1 Clinical Trials

Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas

KOMET
Start date: November 19, 2021
Phase: Phase 3
Study type: Interventional

A global study to demonstrate the effectiveness of selumetinib in participants with NF1 who have symptomatic, inoperable plexiform neurofibromas.

NCT ID: NCT04924543 Completed - Ulcerative Colitis Clinical Trials

OPtical Diagnosis Training to Improve Dysplasia Characterisation in IBD

OPTIC-IBD
Start date: July 7, 2021
Phase: N/A
Study type: Interventional

People with inflammatory bowel diseases (IBD) can be at higher risk of developing abnormal areas in their bowel. These abnormal areas can be due to active inflammation, healed inflammation, polyps or pre-cancerous changes ("dysplasia"). It is for this reason that people with IBD are offered periodic surveillance colonoscopy procedures to identify, characterize and where necessary remove abnormal areas or lesions from the bowel. These can be difficult to characterize correctly, which is important to make the correct endoscopic diagnosis and management plan. Technical advancements in endoscopy mean that more tools are available to identify and characterize these lesions in real time during colonoscopy. Specialists regularly performing gastrointestinal endoscopy and colonoscopy ("endoscopists") will often receive special training, both during their initial postgraduate training and through continuous professional development programs. This study aims to evaluate whether an online training platform can improve the ability of endoscopists to characterize dysplasia in IBD. The goal is to support improved decision-making during IBD surveillance, reporting of dysplastic lesions, and ultimately the care and outcomes of people with IBD.

NCT ID: NCT04924101 Active, not recruiting - Clinical trials for Small Cell Lung Cancer

Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Chemotherapy as First-Line Treatment in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (MK-3475-B99/ KEYNOTE-B99)

Start date: July 15, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the use of investigational agents (MK-4830, boserolimab (MK-5890) and lenvatinib (MK-7902)) in combination with pembrolizumab (MK-3475) and etoposide/platinum chemotherapy for the first-line treatment of participants with extensive-stage small cell Lung Cancer (ES-SCLC). No formal hypothesis testing will be performed for this study.

NCT ID: NCT04924075 Recruiting - Clinical trials for Pancreatic Neuroendocrine Tumor

Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)

Start date: August 12, 2021
Phase: Phase 2
Study type: Interventional

This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

NCT ID: NCT04923165 Completed - Stroke Clinical Trials

Nutritional Status in Subacute Stroke Patients Under Rehabilitation

Nutristroke
Start date: September 4, 2020
Phase:
Study type: Observational

Recently, is becoming more evident a relationship between malnutrition, stroke-related sarcopenia and/or altered systemic oxidative status in patients with subacute stroke . The aim of this study is the evaluation of nutritional status, the presence of stroke-related sarcopenia and systemic oxidative status in patients with subacute stroke outcomes; another aim is to investigate the correlation of nutritional status, the presence of stroke-related sarcopenia and systemic oxidative status on admission with the rehabilitative outcomes.

NCT ID: NCT04921748 Completed - Parkinson Disease Clinical Trials

Neurorehabilitation of Sequence Effect in Parkinson's Disease

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

The sequence effect (SE), defined as a reduction in amplitude of repetitive movements, is a common clinical feature of Parkinson's disease (PD), being a major contributor to freezing of gait (FOG). During walking, SE manifests as a step-by-step reduction in step length when approaching a turn or gait destination (dSE). The investigators studied the effect of a 4-week rehabilitation program on the destination sequence effect in patients affected by Parkinson's disease with and without Freezing of Gait. All subjects were evaluated with inertial gait analysis for dSE recording.