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NCT ID: NCT03926143 Terminated - Solid Tumors Clinical Trials

A Clinical Study of Anetumab Ravtansine in Adults With Solid Tumors Who Have Been Treated in Previous Bayer-sponsored Anetumab Ravtansine Studies

Start date: June 3, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to enable patients with solid tumors, who received anetumab ravtansine in a Bayer-sponsored clinical trial, to continue treatment after their respective study has been closed. The patients will be observed to collect information on how safe and efficient the drug is.

NCT ID: NCT03926130 Completed - Crohn's Disease Clinical Trials

A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

VIVID-1
Start date: July 23, 2019
Phase: Phase 3
Study type: Interventional

The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.

NCT ID: NCT03926104 Recruiting - General Anesthesia Clinical Trials

BNP and Vascular Surgery

BNPinVasc
Start date: December 10, 2018
Phase:
Study type: Observational

Background and rationale of the study: Patients undergoing non-cardiac major surgery show a perioperative cardiac risk and postoperative complications, that can be stratified based on parameters linked to patient's conditions and to surgery types. An accurate identification of this risk could offer numerous advantages for these patients, who's 30-day mortality is around 2%. The identification of the correct risk could lead to a better pre- and postoperative management, that could guarantee a better surgery outcome and a faster postoperative recovery. To this day there is no perfect method to correctly estimate this risk. Various studies show that high BNP levels are linked to cardiac events at 30 and 180 days. Further investigations identify different groups, at low, intermediate and high risk, based on BNP levels. BNP is released by ventricular myocytes in response to a wall distress, due to an increased volume, pressure or myocardial ischemia. So BNP plasma levels could be used as a prognostic and diagnostic marker, improving the cardiac risk stratification in patients undergoing surgery and a much more precise management. This study is determined to do an evaluation of the correlations between pre- and postoperative BNP levels and the incidence of cardiac events in patients undergoing major vascular surgery.

NCT ID: NCT03925818 Terminated - Clinical trials for Helicobacter Pylori Infection

Low Dose Bismuth Versus Lactobacillus Reuteri for H. Pylori Eradication

LactoBismu
Start date: August 29, 2017
Phase: N/A
Study type: Interventional

This study investigates the efficacy of a b.i.d. quadruple therapy containing Pylera® or L. reuteri for H. pylori infection.

NCT ID: NCT03925506 Completed - Colonoscopy Clinical Trials

Predictive Factors of Inadequate Bowel Preparation in Inpatients

QIPS
Start date: February 1, 2019
Phase:
Study type: Observational

About 50-70% only of inpatients who undergo colonoscopy have an adequate bowel cleansing, which is far below the recommended threshold of 90%. Variables associated to inadequate colon preparation have not been assessed yet. Identifying such variables would allow to augment the diagnostic yield of colonoscopy, and also to reduce costs related to the need to repeat colonoscopy. Aim of the present study is to find variables independently associated to an inadequate bowel cleansing and to subsequently build and validate a predictive model, which could prove useful in clinical practice to identify hard-to-prepare inpatients. Secondary endpoints are (i) to assess the proportion of patients with inadequate colon cleansing, (ii) to run a cost-effectiveness analysis between patients with adequate cleansing and patients who need to repeat colonoscopy. Patients undergoing urgent colonoscopy, and patients who take the preparation at home will be excluded.

NCT ID: NCT03925103 Completed - Clinical trials for Early Stage Non-small-cell Lung Cancer (Stage 1-2)

Assessment of Ergonomics in 3D vs 2D Thoracoscopic Lobectomy

Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Video-assisted thoracic surgery (VATS) pulmonary lobectomy is currently widely employed as the first treatment option for surgical management of early stage (stage I-II) non-small-cell-lung-cancer (NSCLC). Thanks to recent technological advances in high definition display systems, three dimensional VATS (3D) has been developed in an attempt of overcoming some optical limits of two dimensional (2D) VATS. In this single center randomized trial our aim is to comparatively assess ergonomics of 3D versus 2D VATS lobectomy for early stage NSCLC.

NCT ID: NCT03924895 Active, not recruiting - Clinical trials for Urinary Bladder Cancer, Muscle-invasive

Perioperative Pembrolizumab (MK-3475) Plus Cystectomy or Perioperative Pembrolizumab Plus Enfortumab Vedotin Plus Cystectomy Versus Cystectomy Alone in Participants Who Are Cisplatin-ineligible or Decline Cisplatin With Muscle-invasive Bladder Cancer (MK-3475-905/KEYNOTE-905/EV-303)

Start date: July 24, 2019
Phase: Phase 3
Study type: Interventional

This is a study of perioperative pembrolizumab or enfortumab vedotin in combination with pembrolizumab in participants who are cisplatin-ineligible or decline cisplatin with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that perioperative pembrolizumab plus radical cystectomy (RC) plus pelvic lymph node dissection (PLND) and perioperative enfortumab vedotin in combination with pembrolizumab plus RC+PLND will achieve superior event-free survival (EFS) compared with RC+PLND alone. With Amendment 5, outcome measures for programmed cell death ligand 1 (PD-L1) combined positive score (CPS) were removed. With Amendment 8, the primary outcome measure of pathologic complete response (pCR) rates was changed to a secondary outcome measure.

NCT ID: NCT03924869 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

Efficacy and Safety Study of Stereotactic Body Radiotherapy (SBRT) With or Without Pembrolizumab (MK-3475) in Adults With Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (MK-3475-867/KEYNOTE-867)

Start date: June 25, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of stereotactic body radiotherapy (SBRT) plus pembrolizumab (MK-3475) in the treatment of adult participants with unresected stage I or II (Stage IIB N0, M0) non-small cell lung cancer (NSCLC). The primary study hypothesis is SBRT plus pembrolizumab prolongs Event-free Survival (EFS) compared to SBRT plus placebo (normal saline solution).

NCT ID: NCT03924856 Active, not recruiting - Bladder Cancer Clinical Trials

Perioperative Pembrolizumab (MK-3475) Plus Neoadjuvant Chemotherapy Versus Perioperative Placebo Plus Neoadjuvant Chemotherapy for Cisplatin-eligible Muscle-invasive Bladder Cancer (MIBC) (MK-3475-866/KEYNOTE-866)

KEYNOTE-866
Start date: June 13, 2019
Phase: Phase 3
Study type: Interventional

A global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.

NCT ID: NCT03924232 Completed - Clinical trials for Bioelectrical Impedance Analysis

The BIA and MUS in the Detection of Nutritional Status in Critically Ill Patients

BUS
Start date: October 1, 2017
Phase:
Study type: Observational

Critically ill patients are characterized by wide variations in their carbohydrate, lipid, and protein metabolism. Such variations can lead to increase in their energy requirement with accelerated protein catabolism and ultimately alterations of their immune and gastrointestinal systems, and in a variable frame time, it lead to a disruption of muscular function that increased the ICU and hospital stay and mortality. There are multiple methods to conduct these measurements. However, the accuracy of these measures could be very scares. Skeletal muscle wasting in the critically ill is often masked by fluid retention. For these reasons, in the last few decades, several different tools have been developed to integrate the clinical and biochemical nutritional evaluations. Among these, the bioimpedance analysis (BIA) and the muscular ultrasonography (MU) seem to be promising tools for this purpose. The aim of this project is to compare and integrate the data collected by BIA and MU and the routinely clinical used parameters of nutrition to define the nutritional status of critically ill patients. The data from these tools and the biochemical and anthropometric nutritional data (including the nutritional support) will be collected at the admission in ICU and followed up within the first week of ICU stay.