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NCT ID: NCT04108728 Active, not recruiting - HIV Infections Clinical Trials

Neuropsychological Development and Executive Functioning of Children Born to HIV- Infected Mothers ( NEUROPSY-HEU )

NEUROPSY-HEU
Start date: November 19, 2019
Phase: N/A
Study type: Interventional

Main objective: to evaluate the executive functioning of the HIV exposed uninfected children (HEU) versus children from the same socio-economic and cultural environment, not infected or affected by HIV. Secondary objective (s): to evaluate Intellectual Quotient, Child development, Behavior, Language and investigate link between executive functioning disorders, exposure to ARVs, HIV and family environment.

NCT ID: NCT04108026 Active, not recruiting - Clinical trials for Non-small Cell Lung Cancer Stage IV

Immunotherapy in Patient With Poor General Condition

SAVIMMUNE
Start date: October 14, 2020
Phase: Phase 2
Study type: Interventional

Immunotherapeutic approaches targeting immune checkpoint proteins PD-1/PD-L1 have recently demonstrated clinical efficacy in several cancer types, and have changed the therapeutic landscape in metastatic melanoma or non-small cell lung cancer (NSCLC). The monoclonal anti-PD-1 antibody nivolumab has been registered by both FDA (Food and Drug Administration) and EMA (European Medicine Agency), for metastatic NSCLC patients, after failure of a prior platinum-based chemotherapy. The approval was based on the results of phase III clinical trials in metastatic NSCLC. But all the trials only enrolled patients with good general condition, PS (Performance Status) 0 or 1. However, the prevalence of poor PS patients at time of diagnosis is high in lung cancer patients. For patients with metastatic NSCLC and PS 3, there is no standard treatment except best supportive care, since all trials that accrued unselected PS 3 patients fail to prove any survival advantage, and most PS >3 patients die within 2 to 4 months from diagnosis. Indeed, these patients are currently excluded from clinical trials. Specific dedicated clinical trials and treatment guidelines for this patient population are urgently needed, taking into account for the high prevalence of such patients.

NCT ID: NCT04107337 Active, not recruiting - Dysodia Clinical Trials

Effect of Vocal Exercises With Straw on Aerodynamic Parameters of Voice (Pressure, Flow) in Dysodic Singers With Nodules

DYSODIE
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

Singers are over-represented in phoniatric consultations; they present increased risk of developing voice disorders. The most common lesion found in singers is nodule. It comes from vocal straining characterized by the use of a pressed phonation mode, resulting in an increase subglottal pressure and a decrease flow rate. Voice therapy aims to restore a more relaxed phonation. There is a growing interest in semi-occluded vocal tract exercises with a straw in therapy; they have positive effects, particularly in terms of aerodynamic parameters such as subglottal pressure and oral airflow. After these exercises, subglottal pressure decreases and oral airflow increases. In other words, patient adopts a more relaxed phonation mode. Several studies have investigated the effect of these straw exercises on dysphonic patients i.e. on speaking voice; no study to date has explored the effect of these exercises on dysodic subjects i.e. on singing voice. The aim of this study is to evaluate the impact of straw exercises compared to open-mouth exercises on aerodynamic parameters in dysodic women singers with nodules.

NCT ID: NCT04106219 Active, not recruiting - Neuroblastoma Clinical Trials

A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma

Start date: June 11, 2020
Phase: Phase 1
Study type: Interventional

The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.

NCT ID: NCT04102098 Active, not recruiting - Clinical trials for Carcinoma, Hepatocellular

A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation

IMbrave050
Start date: December 31, 2019
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus bevacizumab compared with active surveillance in participants with completely resected or ablated hepatocellular carcinoma (HCC) who are at high risk for disease recurrence.

NCT ID: NCT04102020 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia (AML)

A Study of Oral Venetoclax Tablets and Oral Azacitidine Versus Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy

VIALE-M
Start date: March 26, 2020
Phase: Phase 3
Study type: Interventional

This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with AZA. Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with CC-486. Part 2 and Part 3 Randomization of the study were removed.

NCT ID: NCT04101084 Active, not recruiting - Dementia Clinical Trials

Rocking Chair Therapy in Elderly With Dementia: Its Effects on Agitation

Rocking
Start date: October 25, 2019
Phase: N/A
Study type: Interventional

Patients with dementia exhibit a wide range of behavioral symptoms which include mood disturbances (e.g depression, anxiety), behavior and activity disturbances (e.g agitation, aggression, wandering) and psychotic symptoms (e.g hallucinations and delusions). Behavioral disturbances are a major source of caregiver burden and an important contributor to the decision to admit AD patients to institutionalized long-term care. Among the innovative approaches, rocking chair therapy has been introduced as a potential means for reducing agitation in elderly with dementia. Only few studies evaluated the effect of this therapy on the behavioral symptoms in elderly with cognitive impairment. The results were promising, but not sufficiently significant. We propose to perform this study having as a main goal to evaluate the effect of the rocking chair therapy in agitation for home care residents with dementia. The secondary aim of the study will be the evaluation of psychoactive drugs use as well as pain killers. Cohen Mansfield agitation inventory will be employed for the pre- and post-therapy evaluation. Included subjects will be installed in groups of five, rocking chairs will be placed away from other residents in a semicircle in a corner of the dayroom. The therapy sessions will be held every afternoon, for two hours, under the supervision of the unit psychologist and a master's degree psychology student. During the daily session, each resident should be encouraged to actively rock to reach the goal of 60 minutes of rocking accumulated per day. The total duration of the therapy period will be 6 weeks. The use of pharmacological restraint (neuroleptics, anxiolytics) and pain killers will be evaluated before, during and after the six weeks therapy. The expected outcome is a reduction of agitation among elderly with dementia, as well as a reduction in the use of pharmacological restraint and pain killers.

NCT ID: NCT04100954 Active, not recruiting - Laryngectomy Clinical Trials

Cost-effectiveness Analysis of Vocal Rehabilitation With Strengthened Tracheoesophageal Voice Implant Prosthesis Versus Standard Voice Prosthesis in Case of Repeated Intra-prosthetic Leakage After Total Laryngectomy

PHRASAL
Start date: January 21, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the cost-effectiveness of vocal rehabilitation with reinforced inter-tracheoesophageal voice prosthesis versus standard voice prosthesis in case of repeated intra-prosthetic leakage in total laryngectomy patients. This is a one year medico-economic study involving patients carrying a standard voice prosthesis implant and having undergone 2 successive prosthesis replacements within 3 months of interval and/or requiring at least 4 changes in the last 12 months, for intraprosthetic leakage. Eligible subjects will be randomized in 2 groups: reinforced prosthesis with silver coating and double valve (Dual Valve) or standard prosthesis (single unreinforced valve), of the same model as the prosthesis previously implanted in the patient.

NCT ID: NCT04100148 Active, not recruiting - Clinical trials for Congestive Heart Failure

SyncAV Post-Market Trial

SyncAV
Start date: October 3, 2019
Phase: N/A
Study type: Interventional

The SyncAV Post-Market Trial is a prospective, randomized, multi-center trial performed to determine if cardiac resynchronization therapy (CRT) devices programmed with SyncAV ON improve long-term CRT response compared to devices programmed with conventional CRT through evaluation of changes in left ventricular (LV) reverse remodeling.

NCT ID: NCT04100018 Active, not recruiting - Prostate Cancer Clinical Trials

A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer

CheckMate 7DX
Start date: February 6, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and effectiveness of nivolumab with docetaxel in men with advanced castration resistant prostate cancer who have progressed after second-generation hormonal manipulation.