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NCT ID: NCT03131453 Terminated - Alzheimers Disease Clinical Trials

A Study of CNP520 Versus Placebo in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease

GS2
Start date: August 3, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine the effects of CNP520 on cognition, global clinical status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid.

NCT ID: NCT03110263 Terminated - Insomnia Clinical Trials

i-Sleep: Internet-based Treatment for Insomnia

i-Sleep
Start date: June 10, 2016
Phase: N/A
Study type: Interventional

In this study, people who suffer from insomnia will be randomized to one of three study conditions. The first group receives a multicomponent internet-based cognitive behavioral self-help intervention. The second group has access to an internet-based self-help sleep restriction intervention. The third group is a waiting control group. In both active conditions additional care or treatment is allowed. The aim of the study is to investigate the effectiveness of a multicomponent internet-based cognitive behavioral self-help intervention as well as a stand-alone internet-based self-help sleep restriction intervention for insomnia symptoms compared to a waiting list. Assessments take place at baseline, and 8-weeks and 6-months post-randomization. After 8 weeks, participants in the waiting control group get access to the internet-based cognitive behavioural self-help intervention and also fill out questionnaires at 6-months post-randomization.

NCT ID: NCT03110107 Terminated - Advanced Cancer Clinical Trials

First-In-Human Study of Monoclonal Antibody BMS-986218 by Itself and in Combination With Nivolumab in Participants With Advanced Solid Tumors

Start date: May 4, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether BMS-986218 both by itself and in combination with Nivolumab is safe and tolerable in the treatment of advanced solid tumors.

NCT ID: NCT03094715 Terminated - Stroke, Acute Clinical Trials

Efficacy and Safety of Thrombectomy in Stroke With Extended Lesion and Extended Time Window

Tension
Start date: June 20, 2018
Phase: N/A
Study type: Interventional

TENSION (Efficacy and safety of ThrombEctomy iN Stroke with extended leSION and extended time window) is a prospective, open label, blinded endpoint (PROBE), European two-arm, randomized, controlled, post-market study to compare the safety and effectiveness of endovascular thrombectomy as compared to best medical care alone in the treatment of acute ischemic stroke patients with extended stroke lesions defined by an Alberta Stroke Program Early CT Score (ASPECTS) score of 3-5 and in an extended time window (up to 12 hours or unknown time of symptom onset). Up to 665 subjects will be randomized. Primary endpoint will be functional outcome assessed by the modified Rankin scale at 90 days post-stroke ("mRS shift analysis"). By this, TENSION will provide evidence of efficacy and safety of thrombectomy in an acute stroke population with uncertain benefit of endovascular stroke treatment.

NCT ID: NCT03069599 Terminated - Pancreatic Cancer Clinical Trials

Immune Response After Pancreatic Cancer Treatment

IRE Immuno
Start date: February 15, 2017
Phase:
Study type: Observational

The aim of this project is to describe the differential immunologic responses of patients who undergo in situ IRE, margin accentuation IRE with surgical resection of the primary tumor, and surgical resection of the primary tumor only. The primary hypothesis is that IRE induces a long and sustained activation of the cell-mediated immune system, which is distinct from the immune response after surgical resection only. The primary endpoint of this study is the comparison of the CD4+/CD8+ ratio as an indicator of antitumor immunity both longitudinally within a group after the intervention and over time between the three groups. CD4+/CD8+ ratio will be measured preoperatively and at postoperative days 1, 7, 42, and 180. As a secondary outcome, additional measurements will be taken to more specifically characterize the immune response based on peripheral blood samples. Flow cytometry will be used to quantify cell subsets, and ELISA will be used to measure cytokine levels , at the same time-points as for the primary outcome. Each group of patients as described above will consist of 10 consecutive pancreatic cancer patients. Patients aged 18 or older with resectable, borderline resectable, or locally advanced pancreatic cancer will be included. Patients with locally advanced disease will undergo 3 months of preoperative chemotherapy with monitoring to exclude metastatic disease. Main exclusion criteria are cardiac conduction abnormalities and signs of distant metastasis.

NCT ID: NCT03065348 Terminated - Clinical trials for Frail Elderly Syndrome

Perioperative Multimodal Care for Cystectomy Frail Patient

Start date: April 6, 2017
Phase: N/A
Study type: Interventional

Major surgery in the elderly and frail patient is a challenge. Optimal perioperative management is essential for outcome and survival. There is a need for improved multidisciplinary approach to improve postoperative outcome in this patient population at high risk for postoperative morbidity and mortality. Here the investigators will evaluate the implementation of a multimodal prehabilitation program including optimization of nutrition (protein and carbohydrate loading), optimization of preoperative hydration and the use of regional anesthesia during cystectomy and urinary diversion in a series old frail patients and compared/matched them to a historical series of similar patients in terms of early return of quality of life using the Convalescence and Recovery Evaluation (CARE) instrument, cognition, and postoperative morbidity. The importance of patient-reported health status is well recognized and is a facet of healthcare quality. In addition it is a valuable means for quantitatively measuring the implication of technology adoption for the patient, who typically judges the efficacy of a surgical procedure by whether it improves quality of life. The objective of this study is to evaluate the implementation of a multimodal prehabilitation program in a series old frail patients and compared them to a historical series of similar frail patients in terms of early return of quality of life, cognition, and postoperative morbidity. The importance of patient-reported health status is well recognized and is a facet of healthcare quality. In addition it is a valuable means for quantitatively measuring the implication of technology adoption for the patient, who typically judges the efficacy of a surgical procedure by whether it improves quality of life.

NCT ID: NCT03059511 Terminated - Pharmacokinetic Clinical Trials

Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants

Start date: March 3, 2017
Phase: Phase 1
Study type: Interventional

To assess pharmacokinetics parameters for nalbuphine after intravenous and intranasal administration in infants. Also effect on pain score: Neonatal Infant Pain Score (NIPS) and safety will be evaluated with summary of Adverse Events. Inclusion criteria are: Infants 29 days-3 months, minimum Body weight 3.0 kg, Indications: septical work up. Exclusion criteria are: Infants who were born prematurely (before 37 weeks gestation), known kidney or liver disease, known chronic illness.

NCT ID: NCT03054207 Terminated - Hiv Clinical Trials

Impact of Antiretroviral Treatment on Pharmacokinetics and Pharmacodynamics of Thienopyridines in Healthy Volunteers and HIV Patients

IMPACT/R
Start date: June 2015
Phase: Phase 1
Study type: Interventional

HIV patients are at particular risk to develop cardiovascular disease (CVD) as they exhibit multiple risk factors by the nature of their pathology. In addition, the long term exposition to antiretroviral drugs has been associated to an increased risk for CVD. HIV patients can thus potentially receive antiplatelet therapy concomitantly with their antiretroviral treatment. Clopidogrel and prasugrel are thienopyridine antiplatelet agents indicated to prevent the recurrence of ischemic events after coronary arteries stenting. These pro-drugs are mainly bioactivated by cytochromes P450 (CYP) 3A and 2B6 for prasugrel and CYP2C19, CYP3A and CYP2B6 for clopidogrel. Ritonavir is commonly used to "boost" the bioavailability of other HIV drugs through inhibition of CYP3A4 as well as CYP2B6 and CYP2C9. This interaction could therefore reduce clopidogrel and prasugrel efficacy by reducing the formation of their active metabolites. The aim of the present study is to assess the potential drug-drug interaction between clopidogrel/prasugrel and ritonavir. Two groups of 12 male subjects will be constituted (12 HIV patients under ritonavir boosted therapy and 12 healthy volunteers) in a randomized cross-over clinical trial. All subjects will also be genotyped for the CYP2C19. The pharmacokinetics of clopidogrel active metabolite and prasugrel active metabolite will be assessed. Furthermore, the pharmacodynamic response will be evaluated by two gold standard platelet inhibition tests, namely VAsodilator-Stimulated Phosphoprotein Assay (VASP) and VerifyNow® assays. The primary endpoint of this study is to compare the pharmacodynamic response to clopidogrel and prasugrel in HIV patients to that of healthy volunteers.

NCT ID: NCT03053063 Terminated - Clinical trials for Nonalcoholic Steatohepatitis

Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

STELLAR-4
Start date: January 30, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.

NCT ID: NCT03053050 Terminated - Clinical trials for Nonalcoholic Steatohepatitis

Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

STELLAR-3
Start date: February 13, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.