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NCT ID: NCT05379595 Recruiting - Clinical trials for Advanced or Metastatic Colorectal Cancer

A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer

OrigAMI-1
Start date: July 29, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the anti-tumor activity of amivantamab as a monotherapy (Cohorts A, B, and C), to characterize the safety of amivantamab when added to standard-of care (SoC) chemotherapy in participants with metastatic colorectal cancer (mCRC) (Ph2 cohorts), and to assess the recommended phase 2 combination dose (RP2CD) of amivantamab when added to SoC chemotherapy (Ph1b cohorts).

NCT ID: NCT05379556 Recruiting - Long Covid-19 Clinical Trials

LOng COvid COmorbidities: Andrological, Reproductive, Sexual Dysfunctions in Patients Recovered From COVID-19

Start date: January 27, 2022
Phase:
Study type: Observational

Considering the compelling amount of studies focused on patients in the active phase of COVID-19 disease and the scarcity of studies focused on patient cured from disease aimed at evaluating the sequelae of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection, the purpose of the study is to investigate, in patients recovered from COVID-19 disease: 1) whether SARS-CoV-2 infection has induced in male patients, a primary (testicular) and / or secondary (pituitary) damage to the hypothalamic-pituitary-testicular hormonal axis, structural and / or functional damage to the testis and penis, sexual dysfunction or fertility disorders; 2) the prevalence in male and female patients of chemosensory symptoms (olfactory dysfunction) and assess whether there is a correlation between the prevalence, severity, duration and eventual persistence of olfactory dysfunction and the severity of COVID-19 disease. Patients will be evaluated at baseline (at discharge from infectious and/or pneumology unit) and after 3- 12 months. A better definition of the prevalence and type of sequelae after recovery from COVID-19 disease could significantly improve the therapeutic management and long-term follow-up of these patients, with a relevant impact in terms of health resources and public health.

NCT ID: NCT05379413 Not yet recruiting - Clinical trials for Spasticity as Sequela of Stroke

Observational Longitudinal Study on the Outbreak and Management of Stroke Related Spasticity

COLOSSEO
Start date: June 1, 2022
Phase:
Study type: Observational

Stroke is one of the leading cause of death and disability worldwide. Post-stroke spasticity (PSS) is outbreak after a stroke and is featured by disabling muscle stiffness. PSS could manifest in up tp 50% cases within 6 months after a stroke, especially in the upper limb. Despite it is an acknowledged condition it is insufficiently recognized and treated in clinical practice. Focal and regional spasticity could improve with rehabilitation and in selected cases with botulinum neurotoxin (BoNT) type A injections. The latter causes muscle relaxation and fosters neuroplasticity, which is able in turn of ameliorating several patient functional aspects. Recent literature demonstrated that PSS patients treated with early BoNT (within 3 month since PSS outbreak) could improve in their clinical status better than patients with a later treatment. An earlier recognition of PSS predictors could improve patient management. Hence, the investigators are going to perform a multicentric prospective observational real life study with BoNT, based on the best clinical practice and aimed at the early recognition and management of PSS through the identification of 1) early clinical predictors of spasticity (collected within 10 days since stroke), 2) BoNT clinical outcome relative to the timing of the treatment

NCT ID: NCT05378529 Completed - Clinical trials for Atherosclerotic Cardiovascular Disease

A Cross-sectional Study of Lipoprotein(a) Levels in Patients With Documented History of Atherosclerotic Cardiovascular Disease (ASCVD)

Start date: April 19, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to characterize the distribution of lipoprotein(a) (Lp(a)) levels among participants with a history of ASCVD as defined by their medical history and is 2-fold: - Evaluate the distribution of Lp(a) value in the overall participants with documented history of ASCVD - Evaluate the distribution of Lp(a) value in participants with documented history of ASCVD by demographics and regions

NCT ID: NCT05378347 Recruiting - Clinical trials for Abdominal Aortic Aneurysm

Endurant Stent Graft System vs Excluder Endoprothesis: ADVANCE Trial

ADVANCE
Start date: January 5, 2023
Phase: N/A
Study type: Interventional

The purpose of this trial is to generate clinical evidence related to key performance outcomes of Endurant II/IIs Stent Graft Systems verses Gore Excluder / Excluder Conformable AAA Endoprosthesis in subjects with Abdominal Aortic Aneurysms. Subjects are randomized and imaging collected at all follow-up time points to assess the primary endpoint.

NCT ID: NCT05377762 Enrolling by invitation - Epilepsy Clinical Trials

Validation of an Italian Questionnaire of Adherence to the Ketogenic Diet

iKETOCHECK
Start date: March 16, 2022
Phase:
Study type: Observational

The ketogenic diet (KD) represents an effective and safe non-drug treatment for drug-resistant epilepsy in pediatric and adult age based on normocaloric, hyperlipidic (80-90% of the daily energy), normoproteic and hypoglucidic dietary regimen. Adherence to treatment with KD is often difficult in the long term, for the patient and for caregivers, especially in adolescence. There are no tools in the literature other than monitoring ketonemia to measure adherence to the diet. A quality tool, validated by experts, on a large population, would allow for a more solid assessment of adherence to treatment, facilitating clinicians in the interpretation of efficacy results and in implementing an early intervention to adjust the therapy.

NCT ID: NCT05377684 Recruiting - Clinical trials for Early-stage Breast Cancer

Study of Quality of Life and Hormone Levels in Premenopausal Participants With Early Breast Cancer Receiving Triptorelin Plus Additional Cancer Treatment

ROSE
Start date: June 9, 2022
Phase:
Study type: Observational

The main purpose of this study is to evaluate the quality of life of premenopausal participants with Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor-2 (HER2) negative breast cancer who are receiving, in addition to triptorelin, an endocrine cancer treatment. The study will also get more information about: - the effectiveness and safety of triptorelin; - the relationship that could exist between the characteristics of the disease and the treatment chosen by the Investigator.

NCT ID: NCT05376891 Recruiting - Cancer Clinical Trials

Met Non Small Cell Cancer Registry (MOMENT)

Start date: October 4, 2022
Phase:
Study type: Observational

The purpose of this multi-national disease registry is to collect prospectively (with longitudinal follow-up) high-quality, standardized, and contemporaneous data to capture changes in the non-small cell lung cancer (NSCLC) treatment landscape and outcomes over time. The registry will capture data on participants; demographic, clinical characteristics (including biomarker data), treatment patterns, and effectiveness and safety outcomes for advanced NSCLC with mesenchymal-epithelial transition exon 14 (METex14) participants treated with systemic therapy.

NCT ID: NCT05376579 Active, not recruiting - Clinical trials for Active Secondary Progressive Multiple Sclerosis

Impact of Mayzent on aSPMS Patients in a Long-term NIS in Italy

ITASIA
Start date: June 17, 2022
Phase:
Study type: Observational

This is an observational, multicenter, single-arm, prospective study conducted in Italy

NCT ID: NCT05376384 Completed - Ovarian Cysts Clinical Trials

Ovarian Cyst's Enucleation Spillage Score

OC-ESS
Start date: May 12, 2022
Phase:
Study type: Observational [Patient Registry]

Cystic enucleation is one of the most common conservative surgeries in gynecology; it is commonly performed by a minimally invasive approach such as laparoscopy. A high percentage of these surgeries (6-88 % of cases) are complicated by the cystic rupture with intra-abdominal spillage of its contents (spillage). This occurrence affects the surgical and prognostic outcome by lengthening the time of surgery, increasing the risk of postoperative infection or granulomatous peritonitis, of possible second manifestation of the pathology (example: endometriosis), and in the case of neoformation of a carcinomatous nature by leading to an increase in the stage of disease, exposing patients to a prognostic disadvantage and the need for adjuvant treatments also avoidable. In addition, the previous spillage may be associated with the adherent syndrome with repercussions on patients' morbidity and fertility. For these reasons, it is crucial to optimize the selection of patients who are candidates for cystic enucleation. The present study aims to evaluate a series of ultrasound, medical history, and surgical-preoperative parameters to develop a predictive score for the risk of spillage during laparoscopic surgery. Prospective Observational Study. The study aims to enroll 156 patients.