Symptoms and General Pathology

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Nervous System Diseases

Behaviors and Mental Disorders

Syndrome

Apnea

Sleep Apnea Syndromes

Death

Respiration Disorders

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness" and contacted by phone for the collection of cardiovascular and metabolic events, incident cancers and deaths, through a structured questionnaire.

Structured questionnaire to collect cardiovascular and metabolic events, incident cancers and deaths that have occured, as weel as information on CPAP, through telephone interview.

Questionnaire

Marie JOYEUX-FAURE, PharmD

Jean-Louis PEPIN, MD

Marie Joyeux-Faure, PharmD, PhD

Jean-Louis Pépin, MD, PhD

Renaud Tamisier, MD, PhD

The meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the EFCR Department of the CHUGA between 2006 and 2015, presenting a sleep apnea syndrome (SAS) with exploration of their arterial stiffness via the measurement of pulse wave velocity (PWV).

Currently, we do not have long-term follow-up data for these patients.

The first objective of the "PWV Follow-up" project is to collect cardiovascular events in these patients through telephone interviews and a structured questionnaire to determine the prevalence of these events. The prevalence of metabolic events, incident cancers and deaths will be also determined as secondary objectives through the same questionnaire.

Others secondary objectives are to evaluate the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

The meta-analysis "sleep apnea syndrome and arterial stiffness" includes data from 893 patients initially included in 9 studies conducted by the EFCR Department of the CHUGA between 2006 and 2015, presenting a sleep apnea syndrome (SAS) with exploration of their arterial stiffness via the measurement of pulse wave velocity (PWV).

The 9 studies were referred as : ADISAS (NCT011968), AGIRSASADOM (NCT010902), BPCO (NCT004044), BPCO-SAS (NCT01195064), DIAMETASAS, Aortic Dissection (NCT01068691), INFRASAS (NCT010892), VALSAS (NCT004094), NIV-OHS (NCT006030).

The objective of this meta-analysis on individual data was to understand the relationship between the severity of the sleep apnea syndrome (measured by the apnea + hypopnea index) and arterial rigidity at the time of diagnosis of SAS.

Currently, we do not have long-term follow-up data for these patients.

The first objective of the "PWV Follow-up" project is to collect cardiovascular events in these patients through telephone interviews and a structured questionnaire to determine the prevalence of these events. The prevalence of metabolic events, incident cancers and deaths will be also determined as secondary objectives through the same questionnaire.

Others secondary objectives are to evaluate the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

Long-Term Follow-up in Patients Included in the Meta-analysis "Sleep Apnea Syndrome and Arterial Stiffness"

Collection of Long-Term Follow-up Medical Events in Patients Included in the Meta-analysis "Sleep Apnea Syndrome and Arterial Stiffness"

Prevalence of cardiovascular events during the follow-up of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness", through a structured questionnaire.

Prevalence of metabolic events during the follow-up of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness", through a structured questionnaire.

Prevalence of incident cancers during the follow-up of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness", through a structured questionnaire..

Prevalence of deaths during the follow-up of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness", through a structured questionnaire.

Mean CPAP observance (h/night) of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness" to determine its impact on the cardiovascular events occurrence.

Mean CPAP observance (h/night) of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness" to determine its impact on the metabolic events occurrence.

Mean CPAP observance (h/night) of patients included in the meta-analysis "sleep apnea syndrome and arterial stiffness" to determine its impact on the incident cancers occurrence.

University Hospital, Grenoble

Heart and Blood Diseases

Vomiting

Thromboembolism

Signs and Symptoms, Digestive

Thrombosis

Embolism

Embolism and Thrombosis

Vascular Diseases

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Emetics

Aprepitant

HEC or MEC

Describe cardiovascular events in a cancer population receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC).

Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymised and used to develop a patient cohort. All diagnoses and treatment are recorded in the course of routine medical practice.

CV Events in Emetogenic Chemotherapy

Cardiovascular Events in Cancer Patients Receiving Highly Emetogenic or Moderately Emetogenic Chemotherapy

GlaxoSmithKline

Patients included in the ESADA European database and contacted by phone for the collection of cardiovascular and metabolic events, incident cancers and deaths, through a structured questionnaire.

Marie Joyeux-Faure, PharmD, PhDm

The European database ESADA, containing data from more than 30,000 patients with very different severities of obstructive sleep apnea (OSA) syndrome, prospectively collects data from patients referred to academic sleep laboratories in many European countries (https://esada.med.gu.se/). Since 2007, Grenoble is one of the two French centers with Paris and is a very active participant in this European database for patient inclusion and data exploitation.

The first objective of the "ESADA Follow-up and outcomes" project is to collect cardiovascular events during the follow-up of patients in the European database through telephone interviews and a structured questionnaire. Other objectives are to collect metabolic events, incident cancers and deaths in the same population using the same mean.

An additional objective is to assess the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

The European database ESADA prospectively collects data from patients referred to academic sleep laboratories in many European countries (https://esada.med.gu.se/). Since 2007, Grenoble is one of the two French centers with Paris and is a very active participant in this European database for patient inclusion and data exploitation. A partnership agreement exists between University Hospital Grenoble (CHUGA) and ESADA for the reuse of CHUGA data. The data collected at CHUGA as part of the ESADA-Follow-up and outcomes questionnaire are also collected in the other European centers and will be centralized at the level of the coordinating center.

ESADA currently contains data from more than 30,000 patients with very different severities of obstructive sleep apnea (OSA) syndrome. One of the main limitations of this cohort is the relatively limited amount of information concerning the long-term follow-up of the patients included in the registry.

The first objective of the "ESADA Follow-up and outcomes" project is to collect cardiovascular events during the follow-up of patients in the European database through telephone interviews and a structured questionnaire. Other objectives are to collect metabolic events, incident cancers and deaths in the same population using the same mean.

An additional objective at the end of this data collection is to aggregate the follow-up data of more than 10,000 patients from all participating European centers to assess the impact of continuous positive airway pressure (CPAP, the reference treatment for OSA) on the occurrence of cardiovascular and metabolic events and incident cancers, as this is still discussed in the literature.

Long-term Follow-up in Patients Included in the European Sleep Apnea Data Base (ESADA)

Collection of Medical Events Occurring During Long-term Follow-up in Patients Included in the European Sleep Apnea Data Base (ESADA)

Prevalence of cardiovascular events during the follow-up of patients included in the ESADA European database, through a structured questionnaire.

Prevalence of metabolic events during the follow-up of patients included in the ESADA European database, through a structured questionnaire.

Prevalence of incident cancers during the follow-up of patients included in the ESADA European database, through a structured questionnaire.

Prevalence of deaths during the follow-up of patients included in the ESADA European database, through a structured questionnaire.

Mean CPAP observance (h/night) of patients included in the ESADA European database to determine its impact on the cardiovascular events occurrence.

Mean CPAP observance (h/night) of patients included in the ESADA European database to determine its impact on the metabolic events occurrence.

Mean CPAP observance (h/night) of patients included in the ESADA European database to determine its impact on the incident cancers occurrence.

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Hypokinesia

Sexual Dysfunctions, Psychological

Dyskinesias

Neurologic Manifestations

Mental Disorders

Psychotic Disorders

Menopause

Antineoplastic Agents

Methyltestosterone

Testosterone

Testosterone undecanoate

Testosterone enanthate

Testosterone 17 beta-cypionate

Androgens

Hormones

Hormone Antagonists

once daily transdermal testosterone gel, 300 mcg

testosterone gel

placebo gel

Michael C Snabes, MD, PhD

This study is a randomized, double-blind, placebo-controlled, adaptive design, multi-center study of the long-term cardiovascular and breast safety of LibiGel in the treatment of HSDD in postmenopausal women with at least two points of cardiovascular risk and clinical diagnosis of Hypoactive Sexual Desire Disorder (HSDD).

Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Long-Term Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Long-Term Follow-up in Patients Included in the Meta-analysis "Sleep Apnea Syndrome and Arterial Stiffness"	NCT04704401	Sleep Apnea	Questionnaire	18 Years -	University Hospital, Grenoble
Long-Term Follow-up in Patients Included in the Meta-analysis "Sleep Apnea Syndrome and Arterial Stiffness"	NCT04704401	Sleep Apnea	Questionnaire	18 Years -	University Hospital, Grenoble
CV Events in Emetogenic Chemotherapy	NCT01366599	Vomiting Cardiovascular ... Arterial Thromb...	HEC or MEC	-	GlaxoSmithKline
Long-Term Follow-up in Patients Included in the Meta-analysis "Sleep Apnea Syndrome and Arterial Stiffness"	NCT04704401	Sleep Apnea	Questionnaire	18 Years -	University Hospital, Grenoble
Long-term Follow-up in Patients Included in the European Sleep Apnea Data Base (ESADA)	NCT04800341	Sleep Apnea	Questionnaire	18 Years - 80 Years	University Hospital, Grenoble
Long-term Follow-up in Patients Included in the European Sleep Apnea Data Base (ESADA)	NCT04800341	Sleep Apnea	Questionnaire	18 Years - 80 Years	University Hospital, Grenoble
Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women	NCT00612742	Hypoactive Sexu...	testosterone ge... placebo gel	50 Years -	BioSante Pharmaceuticals

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