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NCT ID: NCT03661099 Recruiting - Colon Polyp Clinical Trials

INtegrated Colonoscopy Improvement Program in Italy

incipit
Start date: August 29, 2018
Phase:
Study type: Observational

The Italian Society of Digestive Endoscopy (SIED) and the Italian Association of Gastroenterologists and Hospital Digestive Endoscopists (AIGO) want to develop an effective training program for endoscopists to improve the quality of colonoscopies through careful evaluation of quality indicators and how they can be improved with an appropriate educational program. Primary objective of this study is to evaluate the variation of "Polyp Detection Rate (PDR) and Adenoma Detection Rate (ADR)" obtained by operators at high and low volume of colonoscopy before and after a training period. Secondary objectives are to compare high and low volume endoscopists' performance before and after training comparing by evaluation of withdrawal time; Number polyps / patient and Number adenomas / patient; the percentage and time of intubation of the cecum, ; patient's pain perception based on the Nurse Assessed Patient Comfort Score (NAPCOMS) scale. The study is structured as follow: - A first phase when all endoscopists collect the results of 200 colonoscopies in an electronic Case Report Form (eCRF) is formed(maximum enrollment period 4 months). - A second phase of training through an e-platform in which the endoscopists are offered with an online refresh reviewing the international standard parameters to perform a quality colonoscopy. Once the final training exam have been passed, the endoscopist will be able to access the third phase - A third phase in which the endoscopists will collect prospectively the colonoscopies they perform in an eCRF (maximum enrollment period 4 months).

NCT ID: NCT03661060 Completed - Heart Failure Clinical Trials

BLITZ Heart Failure

BLITZ-HF
Start date: March 8, 2017
Phase:
Study type: Observational [Patient Registry]

To evaluate if Italian Cardiologists are treating Heart Failure (HF) patients according to International guidelines and if a structured educational program can improved their adherence.

NCT ID: NCT03660917 Not yet recruiting - SCA7 Clinical Trials

Riluzole in Patients With Spinocerebellar Ataxia Type 7

Start date: January 1, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Spinocerebellar ataxia type 7 (SCA7) belongs to the dominant forms of inherited cerebellar ataxias (CA), being one of the rarest form. SCA7 has no therapeutic options, so that the relentless course, the important visual deficit that accompanies CA, and the possibility of disease development in childhood are pressing unmet needs. The investigators published encouraging data on riluzole in inherited CA other than SCA7. These results prompted off-label use of riluzole in single cases of SCA7 in Italy and United States, suggesting possible efficacy of the drug in this condition.

NCT ID: NCT03659916 Active, not recruiting - Clinical trials for Progressive Familial Intrahepatic Cholestasis

Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC

Start date: September 28, 2018
Phase: Phase 3
Study type: Interventional

Open Label Extension Study to evaluate long term safety and persistence of effect of A4250 in children with PFIC.

NCT ID: NCT03659448 Recruiting - Clinical trials for Colorectal Neoplasms

Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer

Start date: June 17, 2019
Phase: Phase 3
Study type: Interventional

The performance of SGM-101, an intraoperative imaging agent, will be compared to that of standard "white light" visualization during surgical resections of colorectal cancer.

NCT ID: NCT03659136 Completed - Breast Neoplasms Clinical Trials

The XENERAâ„¢ 1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread

Start date: November 28, 2018
Phase: Phase 2
Study type: Interventional

The main objective of the trial is to assess the efficacy of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with HR+/ HER2- advanced or metastatic breast cancer and non-visceral disease.

NCT ID: NCT03657160 Completed - Clinical trials for Hematopoietic Stem Cells

Vedolizumab in the Prophylaxis of Intestinal Acute Graft Versus Host Disease (aGVHD) in Participants Undergoing Allogeneic Hematopoietic Stem Cell (Allo-HSCT) Transplantation

Start date: February 6, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of vedolizumab when added to background aGvHD prophylaxis regimen compared to placebo and background aGvHD prophylaxis regimen on intestinal aGvHD-free survival by Day +180 in participants who receive allo-HSCT as treatment for a hematologic malignancy or myeloproliferative disorder.

NCT ID: NCT03657043 Completed - Ovarian Cancer Clinical Trials

A Study of Weekly Tisotumab Vedotin for Patients With Platinum-Resistant Ovarian Cancer With Safety Run-in (innovaTV 208)

Start date: March 20, 2019
Phase: Phase 2
Study type: Interventional

This trial will study tisotumab vedotin to find out what its side effects are and to see if it works for platinum-resistant ovarian cancer (PROC). It will test different doses of tisotumab vedotin that are given at different times. It will also compare the side effects and ability to treat tumors of these different doses and schedules. In this study, there will be a safety run-in group of approximately 12 patients that will look at a dose-dense treatment schedule. In a dose-dense schedule, smaller doses are given more frequently. In addition to the safety run-in patients, there will be three groups in the study. One group will get tisotumab vedotin once every 3 weeks (21-day cycles). The two other groups will get tisotumab vedotin once a week for 3 weeks followed by 1 week off (28-day cycles).

NCT ID: NCT03656718 Active, not recruiting - Neoplasms by Site Clinical Trials

A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)

Start date: October 31, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to investigate the effects of nivolumab when given under the skin with or without rHuPH20. This study will include participants with 1 of the following advanced or metastatic tumors approved for treatment with nivolumab monotherapy: - non-small cell lung cancer (NSCLC) - renal cell carcinoma (RCC) - unresectable or metastatic melanoma - hepatocellular carcinoma (HCC) - microsatellite instability-high or mismatch repair deficient colorectal cancer (MSI-H/dMMR CRC) - in Part B, other solid tumors may be considered at the discretion of the Clinical Trial Physician - In addition to the above tumors, Part E will also include participants with metastatic urothelial carcinoma (mUC).

NCT ID: NCT03656536 Recruiting - Clinical trials for Metastatic Cholangiocarcinoma

A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma

FIGHT-302
Start date: June 3, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of pemigatinib versus gemcitabine plus cisplatin chemotherapy in first-line treatment of participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement.