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NCT ID: NCT03410693 Completed - Clinical trials for Carcinoma, Transitional Cell

Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma

FORT-1
Start date: May 31, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy. The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors. At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied.

NCT ID: NCT03410511 Completed - Lung Injury Clinical Trials

Propylene Glycol/Glycerol Intake and Cardiorespiratory Function

PGGICF
Start date: January 15, 2018
Phase: N/A
Study type: Interventional

Propylene glycol/Glycerol intake is increasingly popular. The propylene glycol/glycerol intake effects on cardiorespiratory function are unknown.

NCT ID: NCT03410147 Completed - Healthy Clinical Trials

A Dose-finding and Feasibility Study for a Prolonged 13C-octanoate Breath Test for Gastric Emptying

ANTERO-AC-7
Start date: February 9, 2018
Phase: N/A
Study type: Interventional

The objective of this dose-finding and feasibility study is to establish the optimal 13C-octanoate concentration to be used with slowly infused enteral nutrition to perform a prolonged gastric emptying test using the breath test. More specifically, the aim is to discover the 13C-octanoate concentration that induces a steady state hourly 13C-recovery. This would allow to implement the prolonged breath test protocol in a future clinical investigation in critically ill patients.

NCT ID: NCT03409978 Completed - Cerebral Palsy Clinical Trials

Smartphone App for Analysis of General Movements in Young Infants

Start date: March 5, 2018
Phase:
Study type: Observational

Analysis of spontaneous movements in young infants from video recordings is recommended as an early medical assessment tool for prediction of cerebral palsy in high-risk infants. Such video recording have previously been performed in follow-up programs at hospitals using semi standardized video set-ups. The research group behind this study develops a smart-phone application that makes it possible for parents to video film their infant spontaneous movements at home, upload and send the video for analysis at the hospital provided by experts. The objectives of the study are to assess the feasibility of the In-Motion app for video recording of infant spontaneous movements, upload and send the video to St. Olavs Hospital in Trondheim, Norway, for assessment, and how parents experience this. 90-120 high-risk infants from Norway, Denmark, Belgium, USA, Great Britain and India will participate. Parents will record their infant spontaneous movements and answer questionnaires. Video quality will be evaluated by experts within the field and their use for computer-based assessment will be evaluated.

NCT ID: NCT03409198 Completed - Breast Cancer Clinical Trials

Phase IIb Study Evaluating Immunogenic Chemotherapy Combined With Ipilimumab and Nivolumab in Breast Cancer

ICON
Start date: January 21, 2018
Phase: Phase 2
Study type: Interventional

Breast cancer is rarely curable after metastasis, and the therapeutic options are limited. Interestingly, the host immune response is strongly predictive for the effect of chemotherapy in subgroups of patients with breast cancer. The aim is to release the brake on the immune response by use of ipilimumab, which blocks CTLA-4 and may deplete regulatory T cells, combined with nivolumab (anti PD1). Importantly, it is possible that non-responders to nivolumab/ipilimumab (nivo/ipi) can be turned responders by use of immunogenic chemotherapy.

NCT ID: NCT03408730 Completed - Clinical trials for Hepatitis B Vaccines

Lot-to-lot Consistency of Sci-B-Vacâ„¢ in Adults

Start date: December 14, 2017
Phase: Phase 3
Study type: Interventional

A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vacâ„¢ in Adults

NCT ID: NCT03408691 Completed - Clinical trials for Permeability; Increased

PRObiotic and Stress-related PERmeability

ProSPer
Start date: January 23, 2018
Phase: N/A
Study type: Interventional

This is a single-site exploratory study aiming to demonstrate the effect of a fresh fermented dairy drink containing a probiotic strain on stress-related intestinal hyperpermeability in students defending a bachelor's or master's thesis in front of a jury at the University of Leuven (Belgium).

NCT ID: NCT03408041 Completed - Alzheimer Disease Clinical Trials

Reported Time Between Onset and Diagnosis of Alzheimer's Disease: Correlation With Objective Parameters

Start date: May 1, 2016
Phase: N/A
Study type: Observational

The early diagnosis of Alzheimer's disease is essential to enable patients to have access to the available treatments. However, there is a delay between the diagnosis and the onset of symptoms, which can range from 1 year to more than 5 years. In clinical practice, the hippocampal volume, measured by the Scheltens index, is currently used as a marker of the progression of the disease. The purpose of this study is to determine whether the patient's sex, age and ethnicity can influence the delay in the expression of cognitive troubles reported by the family at the first medical consultation, as well as to determine if there is a correlation between the delay reported by the family and the Scheltens index.

NCT ID: NCT03408028 Completed - Clinical trials for Cognitive Impairment

Therapeutic Intervention Code in a Cognitive Geriatric Unit

Start date: April 1, 2017
Phase: N/A
Study type: Observational

The diagnostic and therapeutic progresses, associated with modifications in lifestyle and socio-cultural level of populations, have led to a remarkable increase in life expectancy. At the same time, the increasing medicalization of the individual has eroded the traditional boundaries between health and illness, normal and pathological state. This leads to the patient losing his sense of ownership of his own death. If most patients died at home before the Second World War, 75% of the population dies in hospital or institution at the present date. Most hospitals and care institutions have developed codes, in multidisciplinary internal consultation, to address the interruption or lack of implementation of treatments that make no sense from a medical point of vue. This avoids therapeutic relentlessness.The code in place within the CHU Brugmann is: - code A: no therapeutic restriction - code B: not to be resuscitated - code C: not to be intensively treated (no escalation in therapeutic treatments) - code D: best palliative care (progressive de-escalation in therapeutic treatments). These codes are established in consultation with the patient or his legal representative and are re-evaluated in a multidisciplinary way every week. Planning a care path and therefore establishing a therapeutic code is particularly important for people with cognitive impairment and dementia because the progressive loss of cognitive abilities complicates the process of decision making. A large part of the admissions are made via the emergency department. For these patients, no therapeutic plan has been established beforehand. However, the perception of the functional and cognitive status of the patient directly influences the intensity of care provided. Cognitive disorders are a risk factor for the exclusion of access to palliative care for the elderly patient. The objectives of this study are: - To establish a record of the therapeutic limitation codes in an acute cognitive geriatric unit - To correlate the therapeutic limitation code with the comorbidities of the patients

NCT ID: NCT03407378 Completed - Parkinson Disease Clinical Trials

A Study to Investigate a New Treatment in Patients With Parkinson's Disease

Start date: June 26, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this clinical trial conducted in patients with Parkinson's Disease is to study the relationship between patient individual profile and their response to IPT803 Adjunct Treatment (treatment response being characterized by movements improvement).