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NCT ID: NCT03631784 Completed - Clinical trials for Non-small Cell Lung Cancer

A Trial of Pembrolizumab in Combination With Chemotherapy and Radiotherapy in Stage III NSCLC (KEYNOTE-799, MK-3475-799)

KEYNOTE-799
Start date: October 19, 2018
Phase: Phase 2
Study type: Interventional

This is a trial in adult participants with unresectable, locally advanced, Stage III non-small cell lung cancer (NSCLC) treated with pembrolizumab in combination with platinum doublet chemotherapy and standard thoracic radiotherapy followed by pembrolizumab monotherapy. The primary hypothesis of the trial is that within each platinum doublet chemotherapy cohort, the percentage of participants who develop Grade 3 or higher pneumonitis is ≤10% and objective response rate (ORR) by blinded independent central review (BICR).

NCT ID: NCT03630861 Completed - Brain Tumors Clinical Trials

Establishment of a Signature of Circulating microRNA as a Tool to Aid Diagnosis of Primary Brain Tumors in Adults

MIRNA
Start date: January 10, 2016
Phase:
Study type: Observational

MIRNA is a prospective multi-center observational study designed to explore 762 plasma microRNAs in patients with malignant CNS tumours: 60 primary glioblastoma (GBM), 20 primary CNS lymphomas and 40 brain metastases in an attempt to establish plasma microRNA signatures specific to GBM capable of distinguishing them from malignant non-glial brain tumours. 20 patients with cerebral stroke and 20 healthy volunteers will also participate in the study, and for each patient, a panel of 762 microRNAs will be screened in plasma.

NCT ID: NCT03630822 Completed - Schizophrenia Clinical Trials

Multicenter, Randomized, Comparative and Prospective Study Evaluating the Impact on the Care Path of an Editorial Program Accompanied by Advance Directives in Psychiatry (DAP) for People Suffering From Schizophrenia, Bipolar I Disorder or Schizoaffective Disorder

DAiP
Start date: January 2, 2019
Phase: N/A
Study type: Interventional

Severe mental illness is accompanied by cognitive fluctuations that can alter decision-making skills and lead to coerced care. Taking into account, on the one hand, the health, social and economic impact of forced hospitalization, on the other hand the importance of self-determination, the reinforcement of the power to act in the evolution of these disorders, new strategies to better reflect the views of people have been developed. Among these, the drafting of Advanced Directives in Psychiatric (ADP), allows people with mental disorders to write while their decision-making skills are restored care instructions in case of decompensation. It is a tool of "advanced therapeutic education" and early prevention of relapses. It is hypothesized that the implementation of drafting accompanied by advance directives to people with severe psychiatric disorders decreases in the short term the number of forced hospitalization care pathway of these people, compared to the subjects having not benefited from this device. This research will take the form of a randomized controlled trial on 3 sites. The "quantitative" evaluation component of results and processes will be completed with a qualitative anthropological and socio-political evaluation component documenting the trajectories of individuals and the implementation of the program, as well as a "participatory research" component aimed at a dialogue between users, researchers and professionals. The patient who is a beneficiary of the "Advanced Directives in Psychiatric" program will be encouraged to complete the " Advanced Directives in Psychiatric" document and will receive support in drafting them. The non-beneficiary patient of the program will follow up with his psychiatrist unchanged. The experimental design of the quantitative component is based on an experimental, randomized, prospective, controlled, parallel study, comparing two groups of subjects with severe psychiatric disorders. This research will assess the effectiveness, efficiency and impact of the " Advanced Directives in Psychiatric" program compared to conventional psychiatric care alone. Ultimately, the objective of describing the effects of the program on health organizations and on the representations and practices of professionals, caregivers and users is at the service of a better understanding of the conditions of possibility of the generalization of this experimentation.

NCT ID: NCT03630718 Completed - Clinical trials for Liver Cirrhosis, Biliary

Trial of Psychoeducational and Hypnosis Interventions on the Fatigue Associated With PBC in Women

CBP-HOPE
Start date: May 27, 2019
Phase: N/A
Study type: Interventional

Fatigue is a clinical symptom that has been described as the most disturbing by around 50% of patients with PBC. It has an important impact on patients' quality of life and is associated with an increased mortality risk. To treat fatigue in PBC, only medical treatments have been tested with limited efficacy or serious sides' effects. In other diseases, mostly cancer, psychological interventions showed efficacy on fatigue decrease. Most interventions consist in psychoeducation with: education about fatigue, development of self-care or coping techniques, activity management and learning to balance between activities and rest. Hypnosis, which consists in a body work for psycho-therapeutic use (e.g., through imagination), has also shown promising results. Moreover, psychological intervention efficacy seems to be influenced by patients' characteristics, such as personality. Therefore, the first aim of the present single-center randomized controlled phase 2 trial is to assess the efficacy of a psycho educational intervention and a hypnosis intervention on PBC patients' fatigue to demonstrate that both psychoeducational and hypnosis interventions decrease patient fatigue.

NCT ID: NCT03630562 Completed - Clinical trials for Age Related Macular Degeneration

Assay of Pro-angiogenic Cytokines in Exudative Age-Related Macular Degeneration

TARMAC-1
Start date: November 26, 2018
Phase: N/A
Study type: Interventional

Anti-VEGF intravitreal injections are the treatment of choice in age-related macular degeneration (AMD). However 37% of patients are unresponsive or poorly responsive to these therapies. It is still not possible to foresee the patient's response to anti-VEGF injections. A poor response may be related to an activation of alternative pro-angiogenic pathways with over expression of many other pro-angiogenic cytokines. The primary goal of this study is to measure the aqueous humor concentration of pro-angiogenic cytokines in AMD patients.

NCT ID: NCT03629834 Completed - Clinical trials for Obstructive Sleep Apnea Syndrome

Internal and Predictive Validity of Epworth Sleepiness Scale to Evaluate Vigilance of Patient Treated for Obstructive Sleep Apnea Syndrome.

SAHOS-TIME
Start date: January 25, 2018
Phase:
Study type: Observational

Presently, there isn't any international recommendation to evaluate vigilance in Obstructive Sleep Apnea Syndrome. The French Society of Sleep Research and Medicine (SFRMS) recommend evaluating professional driver with a MWT but no recommendation exists for other patients. After a minimal treatment of 4 weeks, the physician has to evaluate the drowsiness risk of these patients using either an objective test like the MWT or a subjective one. In the university hospital Amiens-Picardie, since the 01/01/2015, every patient with an Obstructive Sleep Apnea Syndrome diagnosed by a polysomnography or a ventilatory polygraphy had a MWT after 4 weeks of treatment. At each time of the evaluation, Epworth Sleepiness Scale, tiredness score of Pichot, and depressive score of Beck are performed.

NCT ID: NCT03629782 Completed - Severe Asthma Clinical Trials

Characterisation of Patients With Severe Asthma in Primary and Secondary Care Settings in Europe Reported to be Eligible for Biological Therapy

RECOGNISE
Start date: April 26, 2018
Phase:
Study type: Observational

This is a multi-country, multicentre, observational cross-sectional one-visit study of patients suffering from severe asthma in primary and secondary care settings in Europe

NCT ID: NCT03629080 Completed - Clinical trials for Kidney Transplantation

A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients

Start date: December 12, 2018
Phase: Phase 2
Study type: Interventional

HB-101 is a bivalent recombinant vaccine against human CMV infection. This is a randomized, placebo-controlled, phase 2 study to assess the safety, reactogenicity, immunogenicity, and efficacy of HB-101 in CMV-Seronegative patients receiving a kidney transplant from a CMV-Seropositive living donor and CMV-Seropositive patients.Patients enrolled should have a living donor kidney transplantation ideally planned between two to four months after the first injection of study drug (HB-101 or placebo).

NCT ID: NCT03628924 Completed - Clinical trials for Hidradenitis Suppurativa

A Study to Evaluate the Efficacy, Safety, and Tolerability of Guselkumab for the Treatment of Participants With Moderate to Severe Hidradenitis Suppurativa (HS)

NOVA
Start date: September 4, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab in adult participants with moderate to severe hidradenitis suppurativa (HS).

NCT ID: NCT03628651 Completed - Clinical trials for Hepatocellular Carcinoma

Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma

Start date: April 2, 2018
Phase:
Study type: Observational

The primary objective of this study is to obtain de-identified, clinically-characterized whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of hepatocellular carcinoma (HCC).