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NCT ID: NCT03674112 Not yet recruiting - 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

Start date: December 13, 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: NCT03673306 Active, not recruiting - Breast Cancer Clinical Trials

Safety of Pregnancy in BRCA Mutated Breast Cancer Patients

Start date: January 16, 2017
Phase:
Study type: Observational

The present study aims at refining the understanding of the effect of pregnancy on breast cancer outcomes in the specific population of BRCA mutated patients with known history of breast cancer.

NCT ID: NCT03667209 Not yet recruiting - Neck Pain Clinical Trials

Exercise and Pain Neuroscience Education for Patients With Neck Pain: Impact on Pain and Disability

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

This study will compare the effectiveness of pain neuroscience education and neck/shoulder traditional exercises versus pain neuroscience education and neck/shoulder suspension training exercises for patients with chronic idiopathic neck pain (CINP).

NCT ID: NCT03666715 Recruiting - 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: NCT03663556 Recruiting - Clinical trials for Very Preterm Infants

Feeding the Preterm Gut Microbiota - Impact of Infant-feeding on Preterm Gut Microbiota Development

FEEDMI
Start date: May 25, 2017
Phase:
Study type: Observational

Preterm infants are especially vulnerable to gut microbiota disruption and dysbiosis since their early gut microbiota is less abundant and diverse. Several factors may influence infants' microbiota such as mother's diet, mode of delivery, antibiotic exposure and type of feeding. The main goal of this observational study is to evaluate the impact of different types of feeding (breast milk, donor human milk and preterm formulas) on the intestinal microbiota of preterm infants hospitalized in the neonatal intensive care unit (NICU) of Maternidade Alfredo da Costa (MAC). Furthermore, the influence of mode of delivery and the mother's diet, among others factors, on vertical microbiota transmission will be evaluated. After delivery, mothers will be asked to collect their own fecal samples and will be invited to complete a semi-quantitative food frequency questionnaire. Stool samples will be collected from premature infants every 7 days. DNA will be extracted from fecal samples and different bacterial genus and species will be analyzed.

NCT ID: NCT03663036 Enrolling by invitation - 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: NCT03650062 Recruiting - 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.

NCT ID: NCT03648060 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Efficacy of a Digital Biofeedback System for Home-based Rehabilitation After Total Joint Replacement

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

The study was designed to assess the efficacy of a home-based rehabilitation program using a digital kinematic biofeedback system after total hip or knee replacement. This is a single-arm prospective study. Patients will be enrolled pre-operatively and will perform an 8-week rehabilitation program starting between day 7 and 10 after surgery. This program will consist of rehabilitation sessions performed independently by the patient at under remote monitoring from a physical therapist. Outcomes will be measured at baseline, 4 weeks into the rehabilitation program and at the end of the program. The primary outcome is the change in patient performance measure through the Timed-up-and-Go (TUG) test in comparison with the pre-operative score. Secondary outcomes will be measured in terms of: a) patient reported outcomes (Hip or Knee Osteoarthritis Outcome Score) and b) range of motion of the relevant joint (hip or knee).

NCT ID: NCT03648047 Not yet recruiting - Rotator Cuff Tear Clinical Trials

Digital Biofeedback System Versus Conventional Rehabilitation After Rotator Cuff Repair

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

This study was designed to compare the clinical outcomes of a mixed home-based rehabilitation program after arthroscopic rotator cuff repair, incorporating face-to-face sessions as well as sessions performed with a novel digital kinematic biofeedback system against conventional in-person home-based rehabilitation, with the intent of reducing the need for face-to-face sessions. The investigators hypothesize that the clinical outcomes of such a program will be at least similar to those of conventional rehabilitation. Patients will be enrolled pre-operatively and then randomized into 2 groups: experimental group and conventional rehabilitation group. Both groups will perform an 20 to 24-week rehabilitation program starting immediately after surgery. Outcomes will be measured at baseline, 8,12,16 and 20 weeks. In patients where a decision is made to extend the program to 24 weeks, another assessment will be made at this point.

NCT ID: NCT03635359 Enrolling by invitation - Clinical trials for Trisomy 21 and Other Fetal Aneuploidy

Automated Screen for Fetal Aneuploidy

FAST1
Start date: July 15, 2017
Phase:
Study type: Observational

The purpose of this study is to develop and evaluate a blood test and automated microfluidic test platform for the prenatal screening of fetal aneuploidy.