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NCT ID: NCT03674112 Completed - Clinical trials for HER2-Positive Early Breast Cancer

A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer

PHranceSCa
Start date: December 19, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase II, randomized, multicentre, multinational, open-label, cross-over study in adult patients who have completed neoadjuvant chemotherapy with neoadjuvant pertuzumab and trastuzumab and have undergone surgical treatment of human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. The study will consist of two adjuvant treatment periods: a treatment cross-over period and a treatment continuation period. It will evaluate participant-reported preference for a subcutaneously administered fixed-dose combination formulation (FDC SC) of pertuzumab and trastuzumab compared with intravenously (IV) administered pertuzumab and trastuzumab formulations. The study will also evaluate participant-reported satisfaction with pertuzumab and trastuzumab FDC SC and health-related quality of life outcomes; healthcare professionals' perceptions of time/resource use and convenience of pertuzumab and trastuzumab FDC SC compared with pertuzumab and trastuzumab IV formulations; as well as the safety and efficacy of each study regimen.

NCT ID: NCT03666715 Completed - Schizophrenia Clinical Trials

A Study to Analyze the Impact of Treatment With Paliperidone Palmitate on Clinical Outcomes and Hospital Resource Utilization in Adult Participants With Schizophrenia in Portugal

PsiProsper
Start date: August 7, 2018
Phase:
Study type: Observational

The purpose of this study is to investigate the mean number of schizophrenia-related hospital admissions, in adult participants with schizophrenia, occurred during 12 months before and 12 months after initiation of Paliperidone Palmitate 1-month formulation treatment.

NCT ID: NCT03663036 Completed - Rotator Cuff Tear Clinical Trials

Arthroscopic Superior Capsular Reconstruction With Fascia Lata Autograft - Survivorship of the Autograft Analysis

Start date: September 5, 2018
Phase: N/A
Study type: Interventional

An irreparable rotator cuff tear (IRCT) is a challenge, with a controversial definition and different treatment options. None of the latter are exempt of limitations and their survivorship is one of the concerns. In 2013, Mihata et al. proposed a novel treatment option: arthroscopic superior capsular reconstruction using a fascia lata autograft (FL-ASCR) harvested through an open approach. Although no harvest site dysfunction was reported, concerns about donor site morbidity discouraged the use of this type of graft. In 2015, the investigators modified the original FL-ASCR introducing a minimally invasive fascia lata harvesting technique, aiming to reproduce FL-ASCR's promising clinical results in IRCT, while reducing donor site morbidity. The investigators aim to: 1) Evaluate the mid-term outcomes and donor site morbidity impact of FL-ASCR with minimally invasive harvesting; 2) Analyze the mid-term graft integrity to determine its survivorship 3) Establish clinical and imaging graft integrity correlations to guide the future treatment algorithm.

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: 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: 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: 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: NCT03650062 Completed - Acute Pancreatitis Clinical Trials

Patient-reported Outcome Scale in Acute Pancreatitis

PAN-PROMISE
Start date: May 30, 2017
Phase:
Study type: Observational [Patient Registry]

The PAN-PROMISE study (PAtieNt-rePoRted OutcoMe scale in acute pancreatItis-an international proSpEctive cohort study) aims to measure an outcome variable in acute pancreatitis (AP) based in the patient´s experience. PAN-PROMISE is a cohort study involving patients with AP. The patient´s symptom perception will be compared with the opinion of the clinicians and with clinical outcomes.