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NCT ID: NCT02721056 Terminated - Liver Cancer Clinical Trials

NBTXR3 Crystalline Nanoparticles and Stereotactic Body Radiation Therapy in the Treatment of Liver Cancers

Start date: January 28, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this Phase I / II study is to evaluate the safety and preliminary efficacy of NBTXR3 nanoparticles given by intralesional (IL) or intraarterial (IA) injection and activated by Stereotactic Body Radiation Therapy in the treatment of liver cancers.

NCT ID: NCT02717247 Terminated - Clinical trials for Overweight, Obesity and Other Hyperalimentation (E65-E68)

Transcranial Random Noise Stimulation in Food Addiction Treatment

tRNS-FA
Start date: February 2016
Phase: N/A
Study type: Interventional

Obesity is worldwide a public health problem. According to World Health Organization (WHO), overweight and obesity are the fifth death risk factor worldwide. At least 2.8 million adults die each year. Food addiction is one of the causes of obesity that may benefit from new therapeutic options.

NCT ID: NCT02716740 Terminated - Obesity Clinical Trials

Study of Amino Acid Supplementation for Patients With an Excessive Loss of Muscular Body Mass After Obesity Surgery.

MUSCAADE
Start date: February 8, 2017
Phase: N/A
Study type: Interventional

Despite the demonstrable health and quality of life benefits, there are unknowns within consequences of obesity surgery. Weight loss composition is poorly understood. The objective is to have a significant loss of body fat and a limited loss of muscular weight. A cohort study in the nutrition unit at Toulouse University Hospital shows that 3 months and 1 year after surgery, there are 2 phenotypes of patients. The first one is called 'little loss' and is defined by a contribution of muscular weight lower than 15% of the total weight loss. The other one is called 'big loss' and is defined by a contribution of muscular weight higher than 15% of the total weight loss. Causes of these different phenotypes are unknown for the moment. Some amino acids have an anabolic potential. Leucine induces a muscular protein synthesis in clinical situations like hepatic cirrhosis, and some populations like new born and older people. Assuming that, a leucine-enriched essential amino acid supplementation will have a benefit effect on the muscular mass. That is testing the influence of the quality of protein consumed, more than the quantity. An anabolic substance (amino acid here) can lead to gain of muscle only if it is associated to regular physical training, all patients will follow a physical training.

NCT ID: NCT02715804 Terminated - Clinical trials for Pancreatic Ductal Carcinoma

A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

Start date: March 14, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA).

NCT ID: NCT02715466 Terminated - Hypovolemia Clinical Trials

Gelatin in ICU and Sepsis

GENIUS
Start date: April 2016
Phase: Phase 4
Study type: Interventional

This prospective, double-blind randomized controlled trial evaluates the differences in terms of efficacy and safety of gelatin based resuscitation as compared to crystalloid based resuscitation in two parallel groups of patients with severe sepsis / septic shock.

NCT ID: NCT02711137 Terminated - Solid Tumors Clinical Trials

Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies

Start date: May 18, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of the Study is to select a dose and assess the safety and tolerability of INCB057643 as a monotherapy (Part 1 and Part 2) and in combination with standard-of-care (SOC) agents (Part 3 and Part 4) for subjects with advanced malignancies. Part 1 will determine the maximum tolerated dose of INCB057643 and/or a tolerated dose that demonstrates sufficient pharmacologic activity. Part 2 will further evaluate the safety, preliminary efficacy, PK, and PD of the dose(s) selected in Part 1 in select tumor types including solid tumors, lymphomas and other hematologic malignancies. Part 3 will determine the tolerated dose of INCB057643 in combination with select SOC agents; and assess the safety and tolerability of the combination therapy in select advanced solid tumors and hematologic malignancies. Part 4 will further evaluate the safety, preliminary efficacy, PK, and PD of the selected dose combination from Part 3 in 4 specific advanced solid tumor and hematologic malignancies.

NCT ID: NCT02710279 Terminated - Unipolar Depression Clinical Trials

Response to Social Rejection in Suicidal Behavior

SADS-CS
Start date: February 19, 2016
Phase: N/A
Study type: Interventional

Suicide is a major health problem that causes annually a million death worldwild. In the stress-vulnerability model, suicidal behavior (SB) results from the interaction between an individual's predisposition and stressful condition. We hypothesized that the sensitivity to social exclusion may represent a core component of the suicidal vulnerability Recent evidence also suggest that inflammatory mediators plays a critical role in SB. Furthermore, social stressors are particulary strong and specific triggers of inflammatory response. To sum up, patients carrying a suicidal vulnerability are expected to present greater responses to social rejection in terms of inflammatory activity and psychological pain. The aim of the study is to evaluate the psychological and inflammatory responses to a social stressor validated, the Trier Social Stress Test (TSST) . We will also investigate the moderating effect of childhood abuse, attachment, trait rejection sensitivity and social isolation. In the second part of the study, we will also investigate the prospective association between inflammatory responses induces by laboratory paradigms of social rejection and the occurrence of social distress, suicidal ideation and psychological pain in response to social exclusion events in real life (using ecological momentary assessment).

NCT ID: NCT02705924 Terminated - Clinical trials for Hereditary Breast and Ovarian Cancer Syndrome

Impact of a Psychoeducational Intervention on Expectations and Coping in Young Women Exposed to a High HBOC Risk

Start date: April 2016
Phase: N/A
Study type: Interventional

Young female counselees (18-40 years) belonging to HBOC families with a known mutation on BRCA-genes or not, receive a lot of information regarding their cancer risk. Information sources are numerous and sometimes contradictory. Unfortunately, these women face these issues at a key moment of there identity construction (self, relationship, sexuality) while they are not yet concerned by health prevention measures. A special psychoeducational intervention was designed to help these women to better cope with these difficulties. Intervention consists in a week-end session in a thermal center (SPA) during which they will attend short conferences given by specialists (prevention measures, prophylactic surgery, assisted procreation, epidemiology...) and participate to role games and group sharing. Intervention will be evaluated using self-questionnaires completed before intervention and during the following year.

NCT ID: NCT02704910 Terminated - Parkinson Disease Clinical Trials

Lateral Postural Inclination in Parkinson's Disease : Involvement of the Basal Ganglia ?

IPOLAP
Start date: January 2012
Phase: N/A
Study type: Interventional

The objective of this study is to assess the origins of lateral postural inclination presented by some Parkinson disease's patients. Several mechanisms could cause lateral postural inclination. Available data allow to suggest three hypothesis: (troubles of tonus, perception of vertical perturbation, trouble of perception of corporal axis

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.