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NCT ID: NCT02705157 Recruiting - Bone Metastasis Clinical Trials

The OPTIMAL Study - A Prospective Cohort of Patients With Bone Metastases of the Long Bones

OPTIMAL
Start date: January 2016
Phase: N/A
Study type: Observational [Patient Registry]

Rationale: Bone metastases arise in 50% of all patients dying from carcinoma, increasing up to 70% in patients with breast and prostate cancer. The lesions can cause pain and fractures, leading to diminished quality of life and poorer survival. Current knowledge concerning adequate, personalized treatment of metastatic lesions of the long bones in patients with disseminated cancer is insufficient and inconclusive due to lack of large, prospective series with patient reported outcome measures. Objective: The OPTIMAL cohort aims to describe the quality of life and pain perception of patients after local treatment (radiotherapy and/or surgery) of metastases of the long bones, for both the entire cohort as well as for specific treatments separately. With this a more personalized treatment for metastases in the long bones based on expected survival and impending fracture risk can be provided in order to improve functioning and the quality of life for the remaining lifetime in patients with disseminated cancer. Study design: Observational, prospective, multicentre cohort study. Study population: All patients with metastases of the long bones visiting a radiation oncologist or orthopaedic surgeon. Main study parameters/endpoints: Primary endpoints are patient reported quality of life (including functioning) and pain levels. Complications and survival are secondary endpoints. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients in the OPTIMAL cohort will perhaps not directly benefit from their participation. Participation will contribute to deriving patient-specific treatment modalities for future patients with bone metastases of the long bones. Risks associated with participation in the prospective cohort are considered negligible due to the observational nature of the study. The burden for the patients lies in completion of questionnaires, which is considered to be in proportion with the potential value of this research.

NCT ID: NCT02704416 Recruiting - Brugada Syndrome Clinical Trials

Ablation in Brugada Syndrome for the Prevention of VF

BRAVE
Start date: July 2016
Phase: N/A
Study type: Interventional

This trial aims to develop evidence based curative treatment with optimal net benefit for patients with Brugada syndrome.

NCT ID: NCT02704403 Terminated - Clinical trials for Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)

RESOLVE-IT
Start date: March 2016
Phase: Phase 3
Study type: Interventional

The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.

NCT ID: NCT02704364 Completed - Clinical trials for Primary Sclerosing Cholangitis

Phase 2 Study of NGM282 in Patients With Primary Sclerosing Cholangitis

Start date: March 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.

NCT ID: NCT02703753 Terminated - Obesity Clinical Trials

TOP-mums, for a Healthy Start

Start date: July 27, 2016
Phase: N/A
Study type: Interventional

This study evaluates the effect of a lifestyle intervention for women with a pregnancy wish who have a high risk on perinatal morbidity because of overweight or obesity. Half of the patients will receive the lifestyle intervention while the other half will receive usual care. It is hypothesized that an effective lifestyle intervention directed towards healthy living, including reduction of overweight or obesity and, if applicable, smoking reduction, health problems in mothers and their offspring can be prevented.

NCT ID: NCT02703571 Terminated - Clinical trials for Pancreatic Cancer for Phase II

Study of Safety and Efficacy of Ribociclib and Trametinib in Patients With Metastatic or Advanced Solid Tumors

Start date: June 29, 2016
Phase: Phase 1
Study type: Interventional

Phase Ib dose escalation in advanced solid tumors to identify dose for Phase II dose expansion in advanced or metastatic pancreatic cancer and KRAS-mutant colorectal cancer. Open-label, nonrandomized.

NCT ID: NCT02703272 Terminated - Clinical trials for Lymphoma, Non-Hodgkin

A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma

Start date: July 1, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to confirm that the pharmacokinetics of ibrutinib in pediatric participants is consistent with that in adults (part 1) and to assess efficacy (event-free survival [EFS]) of ibrutinib in combination with rituximab, ifosfamide, carboplatin, and etoposide (RICE) or rituximab, vincristine, ifosfamide, carboplatin, and idarubicin (RVICI) background therapy compared to RICE or RVICI background therapy alone (part 2).

NCT ID: NCT02702583 Completed - Solid Tumors Clinical Trials

The Oral Cavity as a Source of Febrile Neutropenia

ORA-FEBRIS
Start date: December 2015
Phase:
Study type: Observational

Febrile neutropenia (FN) is a clinically important adverse effect of myelosuppressive chemotherapy. If patients present with FN, attention is focussed on well-recognized sites of origin of infection: the airways, urinary tracts, and skin. However, infections can be only documented clinically in about two-third of febrile episodes, whereas a causative microbial pathogen cannot be identified in the majority (>70%) of cases. Pre-treatment oral evaluation aimed to identify and eliminate oral/dental foci is only routinely used in patients at high risk for oral complications (i.e. head and neck cancer patients and stem cell transplantation recipients). However, any patient treated with myelosuppressive chemotherapy, be it for cure or palliation, is at risk of developing infection in and/or originating from the oral cavity. Nevertheless, in these patients dental screening is somewhat randomly employed at the oncologist's discretion. More insight into the pre-treatment oral condition and its potential role in FN is mandatory, particularly considering the growing numbers of older patients retaining their natural dentition and the increase of dental diseases and cancer incidence with age. In addition, oral diseases may aggravate chemotherapy-induced oral mucositis (OM). OM is associated with an inflammatory response, which together with ulcerations providing a portal of entry for bacteria, can result in FN and systemic inflammatory syndrome (SIRS) and/or sepsis. Evidence suggests that microorganisms are involved in the pathobiology of OM, but no longitudinal studies using open-end sequencing are available. Furthermore, comparing bacteria identified in blood cultures in febrile patients with those of the oral cavity will expand the knowledge on the role of the oral cavity as a potential source of bacteremia. The investigators expect that the results will provide a scientific base for subsequent intervention studies on the efficacy of dental screening and elimination of foci, and other interventions aimed at modifying the oral environment before and during chemotherapy.

NCT ID: NCT02702180 Completed - Clinical trials for Autoimmune Pulmonary Alveolar Proteinosis

Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis

IMPALA
Start date: March 21, 2016
Phase: Phase 2
Study type: Interventional

This study evaluates inhaled molgramostim (recombinant human granulocyte macrophage-colony stimulating factor [rhGM-CSF]) in the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) patients. A third of the patients will receive inhaled molgramostim once daily for 24 weeks, a third will receive inhaled molgramostim intermittently (7 days on, 7 days off) for 24 weeks and a third will receive inhaled matching placebo for 24 weeks.

NCT ID: NCT02702076 Recruiting - Parkinson's Disease Clinical Trials

Apomorphine in Parkinson's Disease Patients With Visual Hallucinations

Start date: May 2017
Phase: Phase 2
Study type: Interventional

This randomised, double-blind, placebo-controlled trial will evaluate the efficacy of continuous apomorphine infusion compared to placebo in PD patients with visual hallucinations, inadequately controlled with clozapine and cholinesterase inhibitors.