cyrilzakka/clinical-trials huggingface dataset:
Impact of an Intervention with a Narrative Approach in Overusers: a Clinical Trial

The goal of this clinical trial is to compare an intervention with a narrative therapy-based approach with standard care in overusers in general practice . The main question it aims to answer are:

• An intervention with an approach based on narrative therapy can improve the perception of emotional support, and reduce the probability of suffering from anxiety and/or depression, the number of consultations, and the number of medications in primary care overusers.

Participants will 10 individual sessions carried out over five months. The interval between sessions will be two weeks with a specific duration of fifty minutes per session..

If there is a comparison group: Researchers will compare two groups of overusers to see if reduces the number of visits to the primary care doctor.

Background: The best treatment for the excessive use of the consultation is currently being discussed.

Hypothesis: An intervention with an approach based on narrative therapy, compared to standard care, leads to reducing psychosocial distress and reducing the number of consultations with the family doctor.

Objective: To evaluate the effectiveness of an intervention based on co-constructing a new narrative of symptoms of non-organic origin compared to usual clinical care, with respect to affective social support, the probability of suffering from anxiety and/or depression, and the use of the medical consultation.

Methodology: Pragmatic, controlled and randomized, non-masked clinical trial. Study subjects: 264 users (132 in each group, intervention and control) with excessive use of the consultation (95th percentile of the distribution of appointment-type and/or urgent visits to the medicine service). Intervention will be compared with narrative approach + standard care / standard care.

Determinations: Symptoms of anxiety and depression, social support, number of consultations, age, sex, marital status, educational level, income level, employment status.

Statistical analysis: In order to determine the discriminant capacity of the variables associated with the intervention, we will build a multiple regression model in which we will include those that were statistically significant in the bivariate analysis and those that are relevant according to the bibliography.

Expected results: The results will provide evidence on the effectiveness of said intervention.

Application and Relevance: This type of intervention would most likely reduce the pressure on medical-health professionals.

Eligibility Criteria:
Inclusion Criteria:

* Users in the 95th percentile in the distribution of consultations face-to-face, patient self-initiated consultations with PHC services within the period of 1 year.

Exclusion Criteria:

* Drug abuse or dependence, except for nicotine and tetrahydrocannabinol.
* Comorbidity with DSM-IV-TR (American Psychiatric Association, 2000) severe mental disorders.
* Comorbidity with ICD-10 (World Health Organization, 2008) severe cognitive disorders or sensory disabilities.
* Major locomotor mobility limitations or terminal illness
Generalized Anxiety and Seroquel

The 12 week clinical trial of Seroquel in Generalized Anxiety Disorder (GAD) patients will be combined with fMRI experiments.

Subjects will be recruited from clinic patients and known research subjects at McLean Hospital, as well as by advertisements in the media, flyers, and word of mouth. An initial telephone interview will be conducted to determine if potential subjects meet the basic study requirements. Subjects will be also screened for drug use. If no obvious health problems are present, subjects will be scheduled for an evaluation. Upon arrival at the research unit, each subject will first complete a standardized interview schedule designed to obtain personal and background data such as age, marital status, socio-economic status, education, employment, etc. The Research Assistant will give subjects both verbal and written descriptions of the study procedures. After briefing subjects on the reasons for the research, subjects will be given the opportunity to ask questions. When they are ready, subjects will be asked to sign the written informed consent form approved by the Mclean Institutional Review Board (IRB). Functional magnetic resonance imaging scans to examine brain functioning will be obtained from GAD patients (N=30) at baseline and after 12 weeks. Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.

Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Fluency in English
* A diagnosis of GAD
* No pregnancy
* Right-handedness
* Psychotropic medication-free at the start of the study

Exclusion Criteria:

* Pregnancy or lactation
* Any current DSM-IV-TR Axis I disorder
* Any mental retardation or cognitive impairment that precludes informed consent
* Known intolerance or lack of response to quetiapine fumarate
* Substance or alcohol dependence at enrollment
* Participation in another drug trial within 4 weeks prior enrollment
* History of allergic reaction or hypersensitivity to Seroquel or Seroquel XR
* History of prior Seroquel or other antipsychotic agents use
* Contraindications to magnetic resonance imaging
* Treatment with an effective medication for GAD
Preemptive Lung Impedance-guided Therapy of Evolving Acute Heart Failure in Acute Myocardial Infarction Patients

It is well known that 20-25% of patients hospitalized for acute myocardial infarction will develop acute heart failure during their hospitalization. Currently, the investigators have no reliable parameter for prediction of evolving acute heart failure in such a group of patients. As a result, the investigators have no way of preventing acute heart failure. Treatment of these patients only begins after appearance of clinical signs of acute heart failure. Lung impedance monitoring may be a good non-invasive parameter for prediction of evolving acute heart failure. This study will attempt to address whether preemptive lung impedence-guided therapy may prevent the development of overt acute heart failure and improve their clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized in the ICCU for acute myocardial infarction and developing acute heart failure during their hospitalization

Exclusion Criteria:

* Patients with acute myocardial infarction with clinical and radiological signs of acute heart failure at admission
Prevalence and Risk Factors of Epiretinal Membrane in Diabetic and Non-diabetic Patients

Numerous terms have been used to describe epiretinal membrane (ERM): macular pucker, epimacular membrane, surface-wrinkling retinopathy, cellophane maculopathy and preretinal macular fibrosis. It is, by definition, a fibrocellular tissue found on the inner surface of the retina. It is semi-translucent and proliferates on or above the surface of the internal limiting membrane. It causes blurring and metamorphopsia, while mild cases are often asymptomatic.

ERM presence can degrade the acuity and the quality of vision, thus affecting the quality of life. There is evidence that it also has an adverse impact to the treatment options for patients suffering from macular disorders. More specifically, regarding to diabetic retinopathy, ERM seems to have a bidirectional etiopathogenetic relationship with its course and complications.

The aim of this study is to know the prevalence of ERM in the Brussel's population, the risk factors predisposing to ERM formation and if diabetic patients have a significantly higher prevalence of ERM in comparison to general population.


Eligibility Criteria:
Inclusion Criteria:

-Subjects examined in the general or diabetes screening consultations of the Ophthalmology Department of the CHU Brugmann Hospital

Exclusion Criteria:

* Women pregnant or breast-feeding
* Hypersensitivity to tropicamide
* Any macular pathology other than diabetic maculopathy
* Prior retinal photocoagulation
* Prior intravitreal injection
* Prior retinal surgery
Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth

Minimal flow anesthesia has economic and environmental advantages in addition to providing earlier recovery following general anesthesia. There is a paucity of data concerning the effect of minimal flow anesthesia (fresh gas flow \<0,5 l/min) on recovery parameters. The primary objective of this study is to compare the recovery parameters of desflurane and sevoflurane in minimal flow anesthesia while the secondary objective is to compare the effect of these agents on anesthetic depth using bispectral index.


Eligibility Criteria:
Inclusion Criteria:

* Ages between 18 and 65
* Patients undergoing elective surgery under general anesthesia
* Patients with an American Society of Anesthesiologists Classification I or II

Exclusion Criteria:

* Patient refusal
* Emergency surgery
* Patients with a contraindication for minimal flow anesthesia
* Uncontrolled diabetes mellitus
* History of serious systemic disease (cardiac, pulmonary, hepatic)
* Utilization of another analgesic technique such as central or peripheral nerve blocks
The "Motoric Cognitive Risk" Syndrome in the Quebec Population

The overall objective of the proposal is to examine the epidemiology of the newly reported "motoric cognitive risk" (MCR) syndrome, which is a pre-dementia syndrome combining subjective cognitive complaint (i.e.; memory complaint) with objective slow gait speed, in the Quebec elderly population.

Cognition and locomotion are two human abilities controlled by the brain. Their decline is highly prevalent with physiological and pathological aging, and is greater than the simple sum of their respective prevalence, suggesting a complex age-related interplay between cognition and locomotion. Both declines in cognition and locomotion are associated, furthermore the temporal nature of their association has been unclear for a long time. Recently, a systematic review and meta-analysis has provided evidence that poor gait performance predicts dementia and, in particular, has demonstrated that MCR syndrome is a pre-dementia syndrome, suggesting that low gait performance is the first symptom of dementia. The uniqueness of MCR syndrome is that it does not rely on a complex evaluation or laboratory investigations. Indeed, this syndrome combined subjective cognitive complaint and objective slow gait speed, and is easy to apply in population-based settings.

Prevalence and incidence of MCR syndrome, as well as its association with incidence of cognitive decline and impairment, have never been reported in Canada. Nutrition as a determinant of successful aging: The Quebec longitudinal Study (the NuAge study) is a Quebec population-based observational cohort study performed in healthy older community-dwellers adults which provides a unique opportunity to: 1) obtain reliable estimates of MCR syndrome prevalence and incidence, 2) determine the distribution of clinical characteristics associated with MCR syndrome, 3) examine the association of MCR syndrome with cognitive decline and incidence of cognitive impairment in the Quebec elderly population.


Eligibility Criteria:
Inclusion Criteria:

Individuals eligible for this study will be participants of the NuAge study

Exclusion Criteria:

Individuals not eligible for the NuAge study, No information about cognitive complaint, No measure of walking speed, No follow-up completed
Fluid Balance and Body Weight Changes in Critically Ill Adult Patients

Positive fluid status has been consistently associated with worse prognosis in critically ill adult patients.However, observational studies showed poor agreement between fluid balance and body weight changes. The objective of the study is to compare the measurements of FB and BW over time and to assess correlation with ICU mortality.

Positive fluid status has been consistently associated with worse prognosis in critically ill adult patients. Daily and cumulative fluid balance (FB) is a routine nursing activity in intensive care unit (ICU). In view of the potential for errors in the calculation of FB totals and the problem of accounting for insensible fluid losses, measurement of body weight (BW) changes is an alternative non-invasive method commonly used for estimating body fluid status. Its accuracy over FB assumes a one kilogram change in BW equates to a one liter gain or loss in body fluid volume. However, observational studies showed poor agreement between those measurements, particularly among individuals staying more than a week in ICU possibly due to muscle and fat loss as well as bone demineralization. The objective of the study is to compare the measurements of FB and BW over time and to assess correlation with ICU mortality.

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged \>18 years-old admitted to ICU;
* Expected length of ICU stay superior to 24 hours.

Exclusion Criteria:

* Individuals receiving oral diet;
* Actual body weight superior to 227kgs or 501lb.
QCT in ALS Diagnosis, Mechanistic Understanding and Follow-up

Multidisciplinary management of amyotrophic lateral sclerosis (ALS) can significantly increase survival but also improve the quality of life of patients. The evaluation of cortical-spinal motor neuron damage is currently based only on the assessment of clinical data. However, the alteration of the central motor pathway and conduction can be identified and quantified by different techniques using motor-evoked potentials (MEP). The combined quadriceps test (QCT) has been developed to assess central and peripheral motor pathway conduction. This test allows to quantify central and peripheral part of a mixed disorder, and to detect physiological hyporeflexia or hyperreflexia which, in the case of suspected ALS, can lead to interpretation problems.

The evolution of the QCT parameters during the course of pathology will lead to determine the preponderance of an initial central involvement, but also its extension throughout the pathology. The study of these parameters as well as the clinical course of the disease could reveal a correlation between peripheral and central involvement. This link would provide arguments in favor of pathophysiological hypotheses of disease onset and progression. From a prognostic point of view and depending on the quantification of central and peripheral involvement, the QCT would make it possible to characterize the different ALS phenotypes. This phenotypic characterization would help identify prognostic factors at diagnosis.

The investigators propose a cohort study with the exploration of central motor neuron damage by QCT during the course of ALS in order to provide arguments for a better mechanistic understanding and follow-up of this disease with a poor prognosis.


Eligibility Criteria:
Inclusion Criteria:

* A male or female patient of legal age with suspected ALS (bulbar or spinal) who meets the criteria for "possible", "probable" or "definite" ALS according to the Awaji criteria
* Able to give informed consent to participate in the research
* Enrolled in a Social Security plan

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Severe progressive pathology other than ALS.
* Comorbidities with another neurological disease altering motor skills.
* Contraindication to trans-cranial magnetic stimulation: epilepsy, pacemaker, intracranial ferromagnetic foreign body (clip, aneurysm, implants)...
* Chronic alcoholism
* Cognitive disorders or major incapacity making it impossible to understand the study and sign an informed consent (fronto-temporal dementia, psychiatric conditions of psychotic type, language disorders)
* Refusal to participate.
* Patients under legal protection (guardianship, curators, safeguard of justice)
The Development and Evaluation of a Web-based Childbirth and Parenting Intervention Program

Background: The transition to parenthood is stressful for first-time mothers and fathers and links to adverse health outcomes. Despite Internet use's popularity, an effective web-based, individually-tailored intervention to enhance parental self-efficacy and infant health for first-time parents remains lacking.

Objectives: This study aims to develop and evaluate the effectiveness of a web-based, individually-tailored childbirth and parenting intervention program on parenting self-efficacy and infant health outcomes. The feasibility and acceptability of a theory-driven intervention will be examined in first-time mothers and fathers.

Methods: A two-arm, single-blind randomized controlled trial will be conducted to investigate the effects of web-based intervention in the first-time mother and father. Participants will be randomly allocated to a web-based intervention or a control condition. A repeated measurement will be performed.

Anticipatory results: The efficacy of a theory-driven web-based, individually tailored intervention program will provide a valuable contribution to perinatal health care for first-time mothers and fathers.

The primary outcome of parenting self-efficacy and breastfeeding self-efficacy. The secondary outcomes of anxiety, depression, sleep quality, social support, infant health outcomes will be assessed. Data will be analyzed with the intention-to-treat analysis using linear mixed-effects modeling.

Eligibility Criteria:
Inclusion Criteria: for this study are first-time mothers and fathers who are

1. 20 years old and above;
2. primipara with a singleton pregnancy at second and third-trimester gestation;
3. able to read and write in Mandarin;
4. the husband or support partner will be willing to attend the intervention program;
5. able to access and use the Internet by computer and/or smartphone daily.

Exclusion Criteria: are the first-time mothers and fathers who have

1. chronic diseases;
2. obstetric complications;
3. an abnormal fetal screening;
4. unable or unwilling to comply with the requirements of the research protocol;
5. women and their partners did not have time for the web-based intervention program;
6. participation on any other interventional study.
Lung MORphological Modifications Evaluated by Electrical Impedance Tomography During Preoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation (MORPHEIT Study, an Ancillary Study of PREONIV Trial)

Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the intubation of hypoxemic patients.

Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation

Preoxygenation before endotracheal intubation in the ICU is a prerequisite to limit complications, ranging from desaturation, severe hypoxemia and bradycardia with potential cardiac arrest and death. International recommendations suggest the use of non-invasive ventilation (NIV) technique whenever possible. High flow nasal cannula (HFNC) has recently gained growing interest in the ICU as a treatment of acute respiratory failure, to improve extubation success and as a preoxygenation device before endotracheal intubation. Conflicting results have been published.

The PREONIV study was designed to compare NIV, HFNC and conventional preoxygenation with valve bag mask for the preoxygenation before endotracheal intubation.

Investigator propose to add a lung morphology analysis during preoxygenation. Electrical impedance tomography (EIT) is a non invasive tool which analyse lung aeration variations via the evolution of local thoracic impedances with electrical loop circulating around a thoracic belt with electrodes.

The hypothesis is that the technique of preoxygenation might correlate with oxygen desaturation and potential intubation related complications (PREONIV study). Moreover lung morphology modifications evaluated by EIT might be associated with the preoxygenation technique (MORPHEIT study).

Investigator wish to asses lung morphological modifications evaluated by EIT during preoxygenation in a prospective non blinded randomized fashion.

Eligibility Criteria:
Inclusion Criteria:

* • adults patients

  * requiring intubation and hypoxemia (defined by PaO2/FiO2 below 200)
  * patient covered by french health care system
  * patient included in Hopital Estaing, Clermont-Ferrand

Exclusion Criteria:

* • patient refusal

  * intubation for other causes (excluding hypoxemia)
  * impossibility to measure pulse oxymetry value
  * contraindication for NIV : vomiting
  * NIV intolerance
  * cardiac arrest during intubation
Texting for Relapse Prevention

The purpose of this study is to examine whether Texting for Relapse Prevention (T4RP), a text messaging-based early warming for relapse prevention in people who have schizophrenia/SAD, is associated with fewer relapse symptoms compared to a treatment-as-usual control group.

Schizophrenia is among the 20 most debilitating illnesses worldwide, responsible for 1% of the global burden of disease. Schizoaffective disorder (SAD) affects an additional 0.2% to 1.1% of adults. As many as four out of five people who have schizophrenia or SAD relapse within 5 years of recovery from their initial episode. Interventions aimed at early intervention to prevent relapse would impact public health.

The Texting for Relapse Prevention (T4RP) is an innovative service delivery program delivered via text messaging designed for people who have schizophrenia/SAD. The intervention will be tested in a randomized controlled trial against a treatment-as-usual control group which, for most, involved meeting with their therapist every 2 to 4 weeks and meeting with their psychiatrist at least once every 90 days or more frequently as clinically indicated. A total of 40 people with schizophrenia and 5-15 provider participants (depending on the patient distribution across the providers) in the pilot RTC. The study is being conducted by researchers at the Center for Innovative Public Health Research and Johns Hopkins Community Psychiatry Program (JHCPP).

The investigators posit that T4RP will reduce psychiatric morbidity and institutionalization rates and promote recovery by facilitating improved patient-provider communication, promoting medication adherence, helping people self-monitor their early warning signs, and promoting self-management of symptoms.

If T4RP is effective, this cost-effective and easily scalable intervention will make a significant public health impact and reduction in relapse-related costs for people with schizophrenia/SAD.

Eligibility Criteria:
Inclusion Criteria:

* be English-speaking;
* have a chart diagnosis of schizophrenia or SAD
* be able to provide consent (i.e., pass the Capacity to Consent screen)
* own a cell phone and report using the text messaging function
* be currently at their personal baseline with regard to symptoms and functioning as assessed by their provider (i.e., not in relapse and compliant with treatment)
* be actively under the care of a mental health provider enrolled in the program
* agree to continue attending the clinic for the duration of the study
* plan to keep the same cell phone number for the duration of the study
* have at least one of their providers consent to take part in the study

Exclusion Criteria:

* have at least one of their providers consent to take part in the study