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NCT ID: NCT03525548 Completed - Cystic Fibrosis Clinical Trials

A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F)

Start date: August 3, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F)

NCT ID: NCT03525444 Completed - Cystic Fibrosis Clinical Trials

A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)

Start date: June 15, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).

NCT ID: NCT03525210 Completed - Hiv Clinical Trials

Study of Safety, Tolerability and Immunogenicity of Gardasil®9 in Immunocompromised Patients

Start date: April 4, 2018
Phase: Phase 3
Study type: Interventional

Patients with immunodeficiencies are at increased risk of developing persistent HPV infection and as such HPV-related disease (genital warts and cancer). In this study HIV-patients and SOT-patients will receive 3 doses of Gardasil®9. Safety, tolerability and immunogenicity will be evaluated up to one month following the 3rd and last dose of Gardasil®9.

NCT ID: NCT03521206 Completed - Clinical trials for Advance Care Planning

Advance Care Planning in Nursing Homes in Flanders

ACP+
Start date: March 1, 2018
Phase: N/A
Study type: Interventional

Advance care planning (ACP) is a process that supports adults at any age or stage of health in understanding and sharing their personal values, life goals, and preferences regarding future (medical) care. ACP is of particular relevance for frail older adults, particularly in the nursing home setting where an important proportion of older people die. However, the actual implementation of ACP in nursing home practice seems to be a challenge in many countries worldwide, and people often do not get the opportunity to discuss their preferences in advance. This study evaluates the effectiveness of a theory-based advance care planning training programme (ACP+ programme) for nursing homes in Flanders, Belgium, using a cluster randomised controlled trial (cRCT) design. The ACP+ programme aims to integrate ACP in routine nursing home care by training the nursing home staff and management. Residents and their family will receive in-depth information on ACP and participate in one or several ACP conversations, if they wish so. Who can participate? Nursing homes that conform to the eligibility criteria: at least 100 beds, situated in Flanders and did not participate in a similar research or implementation project over the last 4 years. What does the study involve? The researchers will perform a cluster randomized controlled trial (cRCT) to evaluate the effects of an ACP training programme in nursing homes in Flanders (Belgium), accompanied by a process evaluation. Fourteen nursing homes will be randomized to either the intervention group, which will receive the intervention (ACP+ programme), or the control group, in which no additional training regarding ACP (other than that which is part of routine practice) will be provided. The nursing homes in the control group will receive a short training on ACP, as well as all training materials used in the intervention after the last follow-up measurements. At month 0 the researchers will perform a baseline measurement in the intervention and control groups using structured questionnaires to be filled in by all care staff in the nursing home. At the end of month 8, the same questionnaires will be administered again in all nursing homes (follow-up). The process evaluation will employ structured diaries for ACP trainers, attendance lists for training sessions, audiotaping of a sample of ACP conversations and individual and group interviews with staff and management of the intervention homes. Hypotheses The primary hypothesis is that the introduction of the ACP+ programme in nursing homes will improve the knowledge and self-efficacy of nursing home care staff regarding advance care planning.

NCT ID: NCT03519373 Completed - Pregnancy Clinical Trials

Pertussis Immunization During Pregnancy & HIV Infection

Start date: March 1, 2017
Phase:
Study type: Observational

The impact of chronic HIV infection and pregnancy on different aspects of the humoral response to pertussis immunization with the TDaP vaccine will be studied. The parameters will be measured in 3 groups (HIV-infected pregnant, HIV-uninfected pregnant and HIV-uninfected non pregnant) at different time points before and after immunization (7-10 days, 30 days and at delivery). The transfer ratio and the quality of maternal antibodies will be studied in cord blood.

NCT ID: NCT03517956 Completed - Clinical trials for Advanced or Metastatic Solid Tumor

Phase 1 Study of the Combination of Rogaratinib With Copanlisib in Patients With Fibroblast Growth Factor Receptor (FGFR)-Positive, Locally Advanced or Metastatic Solid Tumors

ROCOCO
Start date: July 25, 2018
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to determine the safety, tolerability, maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) and efficacy of rogaratinib in combination with copanlisib in patients with locally advanced or metastatic solid tumors that are mRNA-positive for at least one FGFR1-4 subtype. The secondary objectives of this study are to characterize the pharmacokinetics (PK) of rogaratinib and copanlisib alone and in combination, and to assess the anti-tumor efficacy of rogaratinib in combination with copanlisib for locally advanced or metastatic solid tumors that are mRNA-positive for at least one FGFR1-4 subtype.

NCT ID: NCT03517540 Completed - Clinical trials for Non-alcoholic Steatohepatitis (NASH)

Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis

TANDEM
Start date: September 11, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study was to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.

NCT ID: NCT03516838 Completed - Clinical trials for Dental Caries in Children

Comparison of ACTIVA BioACTIVE Versus Compomer in Restoring Dental Decay in Primary Molar Teeth

Start date: January 2017
Phase: Phase 4
Study type: Interventional

A clinical trial to evaluate a filling material (ACTIVA) and compare it to a traditional filling material (compomer) to restore decayed deciduous teeth in children

NCT ID: NCT03516721 Completed - Obesity Clinical Trials

Chronotropic Incompetence During Exercise in Obese Adolescents: Clinical Implications and Pathophysiology

CICO
Start date: November 1, 2016
Phase: N/A
Study type: Interventional

A reduction in peak heart rate (HR) and suppressed HR response during exercise is highly prevalent in obese populations. This phenomenon is also known as chronotropic incompetence (CI). In adult obese individuals, CI is independently related to elevated risk for major adverse cardiovascular events and premature death. Despite the established association between CI and prognosis in adult populations, the prognostic relevance of CI in adolescents with obesity has however deserved no attention, but is important. CI during exercise testing may indicate various, yet undetected anomalies, such as altered blood catecholamine and/or potassium concentrations during exercise, structural myocardial abnormalities or ventricular stiffness, impaired baroreflex sensitivity and cardiovascular autonomic dysfunction, atherosclerosis, or cardiac electrophysiological anomalies, which all have been detected in obese children and adolescents. However, whether CI during exercise testing may be a sensitive and specific indicator for these anomalies in obese adolescents has not been studied yet. In addition, the exact physiology behind obesity and development of heart disease remains to be studied in greater detail in obese adolescents. In this project, we examine the prevalence of CI (during maximal cardiopulmonary exercise testing, CPET) in 60 obese adolescents (aged 12-16 years) vs. 60 lean adolescents, and study the association between CI and changes in CPET parameters, lactate, catecholamine and potassium concentrations during CPET, biochemical variables, and cardiac electrophysiology (by ECG recording). In addition, the relation between CI and cardiac function (echocardiography) will be examined in a subgroup (29 lean and 29 obese) of these adolescents. In this regard, the diagnostic value of HR (responses) during maximal exercise testing will be clarified in obese adolescents, and the physiology behind the elevated risk for heart disease in obese adolescents can be explored.

NCT ID: NCT03515694 Completed - Clinical trials for Time of a TOF Ratio >0,9

Minimal Optimal Dose of Sugammadex in Elective Surgery

Start date: April 3, 2018
Phase: Phase 4
Study type: Interventional

Time of appearance of TOF Ratio >0,9 with different doses of Sugammadex