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NCT ID: NCT05410951 Recruiting - BRCA1 Mutation Clinical Trials

LobularCard Trial: Searching for Novel Germline Mutations in Lobular Breast Cancer Patients

LobularCard
Start date: May 16, 2022
Phase:
Study type: Observational

This is a cross-sectional and retrospective study of a cohort of patients with invasive lobular breast cancer (LBC) or in situ lobular neoplasia (LIN3). The main endpoint is the relative frequency of patients with a germline mutation using a recent panel including 113 genes from the "Illumina" protocol. In case of identification of a novel pathogenetic germline mutations, a personalized follow-up will be offered to each patient (in case of genes at moderate-, low-penetrance), or prophylactic mastectomy (in case of genes at high-penetrance). Breast screening in moderate-, low-penetrance mutated patients should be performed periodically using digital mammography, ultrasound and MRI, and will be routinely observed. Patients will be scheduled for follow-up at six-month intervals for 5 years at our outpatient clinic, and yearly thereafter

NCT ID: NCT05410405 Completed - Clinical trials for Edentulous; Alveolar Process, Atrophy

Osseodensification Drills Versus Piezoelectric Surgery

Start date: November 15, 2020
Phase: N/A
Study type: Interventional

implant stability is the first requirement for implant success. the aim is to assess whether different implant site preparation technique may impact the value of the primary stability.

NCT ID: NCT05410379 Completed - Clinical trials for Atrial Fibrillation (AF)

Antral Lesions Characterization of a New Cryoballoon Ablation System in Terms of Local Impedance Drop

CryoLID
Start date: September 15, 2021
Phase:
Study type: Observational

Atrial fibrillation (AF) is defined as a supraventricular tachyarrhythmia with uncoordinated atrial electrical activation and consequently ineffective atrial contraction. Electrocardiographic characteristics of AF include: irregularly irregular R-R intervals (when atrioventricular conduction is not impaired), absence of distinct repeating P waves, and irregular atrial activations. Different AF classifications have been proposed but, traditionally, four patterns of AF are distinguished, based on presentation, duration, and spontaneous termination of AF episodes. Paroxysmal AF, that terminates spontaneously or with intervention within 7 days of onset. Persistent AF that is continuously sustained beyond 7 days, including episodes terminated by cardioversion (drugs or electrical cardioversion) after >7 days. Long-standing persistent (continuous AF of >12 months' duration) when decided to adopt a rhythm control strategy. Permanent AF, that is accepted by the patient and physician, and no further attempts to restore/maintain sinus rhythm will be undertaken. The purpose of this study is to perform assessments of local impedance before and after cryoablation performed with the new POLAR X cryoballoon, in order to characterize the quality of the lesion and possibly to associate it with the acute success and 12 months AF recurrence-free rate.

NCT ID: NCT05410314 Completed - Fertility Disorders Clinical Trials

Nutritional Supplement Based on Myo-inositol-D-chiro-inositoln in Long-term Survivors of Lymphoma

Linf-inositol
Start date: February 7, 2020
Phase:
Study type: Observational

The progressive improvement of lymphoma treatment has led to an important prolongation of patient survival and life expectancy. Therefore, the principal International scientific societies of oncology, recommend Long-term Survivors of Lymphoma to join fertility programs. Specifically, fertile age patients should be assisted by a multi-disciplinary team including specialists dedicated to fertility preservation in oncology, in order to support the completion of the reproductive project. In general population, the use of Inositol was spready considered an effectives choice to contrast ovarian dysfunction with consequently improvement of reproductive outcomes, so it may represent an adjuvant strategy for this purpose. Therefore, the investigators conducted a pilot study to evaluate the potentialities of this nutritional supplement with the aim to optimize the reproductive function in Long-term Survivors of Lymphoma. Despite the limited number of cases and short observational time, this pilot investigation could represent a potential cornerstone for further insights, discussions, and applications

NCT ID: NCT05409976 Recruiting - Venous Leg Ulcer Clinical Trials

The GORE® VIAFORT Vascular Stent IVC Study

Start date: October 25, 2022
Phase: N/A
Study type: Interventional

This study is a prospective, multicenter, non-randomized, single-arm study to evaluate the performance, safety, and efficacy of the GORE® VIAFORT Vascular Stent for treatment of symptomatic inferior vena cava obstruction with or without combined iliofemoral obstruction in adult patients.

NCT ID: NCT05409872 Recruiting - Leiomyoma, Uterine Clinical Trials

Effects of Vitamin D, Epigallocatechin Gallate, Vitamin B6, and D-Chiro-inositol Combination on Uterine Fibroids

DEFIB
Start date: September 15, 2022
Phase: N/A
Study type: Interventional

Randomized (1:1) double-blind, single-center controlled trial to evaluate the efficacy of 3 months of treatment with Epigallocatechin gallate, vitamin D, D-Chiro-inositol, and vitamin B6 on symptoms related to uterine fibroids

NCT ID: NCT05409066 Recruiting - Clinical trials for Follicular Lymphoma (FL)

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma

EPCORE FL-1
Start date: September 20, 2022
Phase: Phase 3
Study type: Interventional

Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world. Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05408286 Completed - Quality of Life Clinical Trials

Post Covid-19 Quality of Life After Hospital Discharge in Patients Treated With NIV/C-PAP

VIDI-CAP
Start date: November 1, 2020
Phase:
Study type: Observational

A multicenter longitudinal study with data collection at 4 and 8 months after hospital discharge.

NCT ID: NCT05408182 Not yet recruiting - Colorectal Cancer Clinical Trials

Early Discharge After Robotic Colorectal Surgery (eRCS): a Prospective Observational Study

eRCS
Start date: June 1, 2022
Phase:
Study type: Observational [Patient Registry]

The enhanced recovery after surgery (ERAS) scheme has improved recovery of patients by addressing the surgical stress and enabling a proactive perioperative care which has proven to decrease postoperative complications and reduce hospital stay. ERAS had a major beneficial effect in open colorectal surgery, while in laparoscopic surgery the additional benefit was somewhat less. Also, current literature is not clear if ERAS can improve operative outcomes of robotic colorectal surgery. Starting from the already proven ERAS protocol, we aim to build a selective enhanced recovery scheme and a standardized early follow-up pathway enabling early safe discharge of low-risk patients after robotic colorectal surgery. This observational study will also design and assess the feasibility and clinical outcomes of an Early discharge Colorectal Surgery (eRCS) protocol which may be used to discharge patients in postoperative day 1 after robotic colorectal resections through close virtual and outpatient follow-up.

NCT ID: NCT05408039 Active, not recruiting - Hyperkalemia Clinical Trials

Tracking Treatment Pathways in Adult Patients With Hyperkalemia.

TRACK
Start date: July 14, 2022
Phase:
Study type: Observational

This study aims to increase the understanding of Hyperkalemia (HK) management, treatment patterns, and the treatment decision-making process for the management of patients with HK over a period of up to 12 months. The generation of real-world evidence (RWE) to understand the treatment management decision rationale and to prospectively describe patient characteristics, treatment management patterns among patients with HK is of importance to improve adherence to guidelines and improve patient care. The primary objective: • Describe HK management decisions, their rationale and treatment expectations. The secondary objective: • Describe baseline characteristics and longitudinal clinical variables in patients with HK. The exploratory objective: • Describe patient awareness and satisfaction with their HK treatment management across the study period.