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NCT ID: NCT03661528 Completed - Clinical trials for Acute Intracranial Hemorrhage

Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor

Start date: June 6, 2019
Phase: Phase 4
Study type: Interventional

Randomized, controlled clinical trial evaluating the efficacy and safety of andexanet alfa versus usual care in patients with intracranial hemorrhage anticoagulated with a direct oral FXa anticoagulant

NCT ID: NCT03661320 Active, not recruiting - Clinical trials for Urinary Bladder Neoplasms

A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

Start date: November 6, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).

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: NCT03654274 Completed - Endometriosis Clinical Trials

SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain

Start date: May 22, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term efficacy and safety of relugolix 40 milligram (mg) once daily co-administered with low-dose estradiol (E2) and norethindrone acetate (NETA) for up to 104 weeks on endometriosis-associated pain in participants who previously completed a 24-week treatment period in one of the parent studies (MVT-601-3101 or MVT-601-3102).

NCT ID: NCT03653507 Active, not recruiting - Clinical trials for Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

GLOW
Start date: November 28, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of zolbetuximab plus capecitabine and oxaliplatin (CAPOX) compared with placebo plus CAPOX (as first-line treatment) as measured by Progression Free Survival (PFS). This study will also evaluate efficacy, physical function, safety, and tolerability of zolbetuximab, as well as its effects on quality of life. Pharmacokinetics (PK) of zolbetuximab and the immunogenicity profile of zolbetuximab will be evaluated as well.

NCT ID: NCT03653026 Completed - Clinical trials for Ulcerative Colitis (UC)

A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis

U-Accomplish
Start date: December 6, 2018
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT03650517 Recruiting - Colorectal Cancer Clinical Trials

Minimally Invasive Right Colectomy Anastomosis Study

MIRCAST
Start date: November 1, 2018
Phase:
Study type: Observational

Right colectomy (hemicolectomy) involves the removal of the cecum, the ascending colon, the hepatic flexure, the first one-third of the transverse colon, part of the terminal ileum, and the associated regional fat and lymph nodes, and is the accepted treatment for malignant neoplasms of the right colon. A minimally invasive approach is commonly used for right colectomy, with studies reporting reduced complications, less blood loss, and hospital stay when compared to an open approach. However, there remains controversy regarding whether robotic assistance is advantageous for this technique and whether an intracorporeal (ICA) or extracorporeal anastomosis (ECA) is best. MIRCAST is a prospective, observational, international, multi-center, 4-parallel-cohorts study. Sites or surgeons will select a cohort of the study for which they are qualified. Four cohorts will be the subject of study: 1. Robotic Right Colectomy with ICA 2. Robotic Right Colectomy with ECA 3. Laparoscopic Right Colectomy with ICA 4. Laparoscopic Right Colectomy with ECA All patient assessments will be done according to the sites standard of care. Parameters routinely recorded during right colectomy surgery will be collected prospectively. Enrolled subjects will undergo assessments at the following intervals: pre-operative, operative, discharge, 30 days, 3 months, 1 year and 2 years post-surgery.

NCT ID: NCT03650452 Completed - Epilepsy Clinical Trials

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies

ELEKTRA
Start date: August 8, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.

NCT ID: NCT03650114 Recruiting - Clinical trials for Relapsing Multiple Sclerosis

Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MS

ALITHIOS
Start date: December 28, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to collect long-term safety, tolerability, effectiveness and health outcomes data in eligible subjects who have participated in a Novartis ofatumumab clinical MS study. Vaccination sub-study The purpose of this research sub-study is to find out the effects of ofatumumab on the development of antibody responses to selected vaccines and keyhole limpet hemocyanin (KLH) neo-antigen in subjects with relapsing multiple sclerosis (RMS).