louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05626296: Molecular Network Characteristics of Phlegm-heat Syndrome in Ischemic Stroke Based on Multi-omics Integrated Analysis
Official title: Molecular Network Characteristics of Phlegm-heat Syndrome in Ischemic Stroke Based on Multi-omics Integrated Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke, Acute
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
First posted: 2022-11-23
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 50 to 80 years with acute ischemic stroke within 72 hours of onset. Moreover, these patients fit the diagnosis of phlegm-heat syndrome or non-phlegm-heat syndrome.

Brief summary: The molecular characteristics of ischemic stroke with phlegm-heat syndrome and candidate biomarkers were identified based on multi-omics data. The main purpose of this study is to validate the molecular characteristics and biomarkers of phlegm-heat syndrome in ischemic stroke, and to demonstrate the association of biomarkers with clinical outcomes.

Detailed description: This is a cohort study in patients with ischemic stroke. The demographic characteristics, TCM syndromes, and other baseline information will be recorded. At the same time, baseline peripheral blood will be collected. These participants will be followed up to 90 days of onset, and 90-day modified Rankin scale (mRS) scores will be assessed. The collected blood samples will be tested by multi-factor detection technology for candidate biomarkers.

Eligibility criteria: Inclusion Criteria:

* Acute ischemic stroke, were confirmed by magnetic resonance imaging (MRI).
* Symptom onset within 72 hours.
* Diagnosis of phlegm-heat syndrome or non-phlegm-heat syndrome.
* Male or female ≥ 50 years and ≤ 80 years.
* With written informed consent.

Exclusion Criteria:

* Planned or already receiving intravenous thrombolysis or endovascular treatment.
* Acute infectious diseases or acute exacerbations of chronic diseases within one month before enrollment.
* Patients with previous stroke.
* Renal or hepatic insufficiency, tumors, immune diseases, severe underlying diseases.
* Other conditions that may affect the collection and evaluation of clinical information (e.g., severe aphasia, mental illness).

Primary outcomes:
measure: Omic biomarkers associated with phelm-heat syndrome in ischemic stroke
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02130596: An Acceptance-Based Behavioral Intervention vs. Nutritional Counselling for Weight Loss in Psychotic Illness
Official title: A Pilot Study of an Acceptance-Based Behavioral Intervention Versus Nutritional Counseling for Weight Loss in Psychotic Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychotic Illnesses
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2014-05-05
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity occurs at 2-3 times the general population rate in persons living with a psychotic illness. The risk of obesity-related serious medical conditions like diabetes and heart disease are also two to three times higher in this population. Traditional behavioral weight management approaches help more than half of these individuals to lose weight, but a significant proportion are not helped. This pilot study is intended to determine the feasibility, efficacy, acceptability, and potential clinical utility of an intervention that integrates mindfulness, acceptance, distress tolerance, and motivation and commitment combined with traditional behavioral strategies for weight loss. This is the first study to investigate such an acceptance-based behavioral intervention for weight loss in psychotic illness. The results from this study will help to determine whether future research in this area is warranted with a larger sample, over a longer period of time.

Primary hypothesis: Weight loss will be greater in individuals who receive the acceptance based behavioral intervention, relative to those who receive nutritional counseling.


Eligibility criteria: Inclusion Criteria:

* BMI \> 25.0
* Diagnosed psychotic illness (i.e., schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, major depressive disorder with psychotic features, substance-induced psychotic disorder, and psychotic disorder not otherwise specified).

Exclusion Criteria:

* Inability to provide informed consent
* Prediabetes or type 2 diabetes mellitus
* Current enrollment in another formal weight management program
* Brief Psychiatric Rating Scale (BPRS) ratings of 4 or more on any one of Grandiosity (Item #6), Suspiciousness (Item #7), Hallucinations (Item #8), Unusual Thought Content (Item #9), or Conceptual Disorganization (Item #10), or a BPRS total score of 80 or more.

Primary outcomes:
measure: Weight (kg)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Rohan Ganguli, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00038896: Study Evaluating Venlafaxine ER in Adults With Panic Disorder
Official title: A Double-blind, Placebo-controlled, Parallel-group, Flexible-dose Study of Venlafaxine Extended-release Capsules in Adult Outpatients With Panic Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Panic Disorder
Keywords: Panic
Disorder
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2002-06-07
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine the efficacy, safety, and tolerability of a flexible dose of venlafaxine extended-release (ER) capsules administered for 10 weeks in the treatment of adult outpatients with panic disorder (PD) in a placebo-controlled phase III study.


Eligibility criteria: Inclusion Criteria:

* A male or female outpatient
* Be at least 18 years of age and legal age of consent
* Meet DSM-IV criteria for PD (with or without agoraphobia) for at least 3 months before study day 1

Exclusion Criteria:

* Treatment with venlafaxine (IR or ER) within 6 months of study day 1
* Known hypersensitivity to venlafaxine (IR or ER) or related compounds
* History or presence of any clinically important hepatic, renal, or other medical disease that might compromise the study or be detrimental to the patient (eg, clinically important cardiac arrhythmia, unstable diabetes, carcinoma \[except basal cell epithelioma\], uncontrolled hypertension)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Liebowitz MR, Asnis G, Mangano R, Tzanis E. A double-blind, placebo-controlled, parallel-group, flexible-dose study of venlafaxine extended release capsules in adult outpatients with panic disorder. J Clin Psychiatry. 2009 Apr;70(4):550-61. doi: 10.4088/jcp.08m04238. Epub 2009 Apr 7.
Clinical trial NCT04581096: Mapping COVID-19 Spread in a Tertiary Hospital
Official title: Evaluation of the Response of COVID-19 Spread With a Spatiotemporal Analysis in a Tertiary Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Spatial Visualization
Neural Network
Respiratory Disease
Pandemic
Disease Spread
Lead sponsor: Hospital General Universitario de Valencia
Sponsor class: OTHER
Collaborators: name: University of Valencia
First posted: 2020-10-09
Enrollment: 2646
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a positive test (PCR or serology) for SARS-CoV-2 in an outpatient regime system

Brief summary: One of the major problems in suppressing the spreading of an epidemic resides in understanding and monitoring its propagation patterns, and in evaluating how these are modified by enforced policies. The standard solution requires detailed information at the microscopic scales, e.g. how infected people have moved and whom they came in contact with, which is hardly ever available. The researchers propose a novel approach to the study of the propagation of COVID-19, in which a proxy of this information is derived at macroscopic scales. This will be based on two ingredients: the spatiotemporal study in shiny with mathematical models with aggregated or non aggregated data and the reconstruction of functional networks of spreading patterns, and the development of a supporting software.


Eligibility criteria: Inclusion Criteria:

* positive test (PCR or serology) for SARS-CoV-2
* outpatient follow-up

Exclusion Criteria:

* hospitalisation in ward or ICU

Primary outcomes:
measure: spatiotemporal spread
timeFrame: February 1, 2020 to September 30, 2020
Secondary outcomes:
measure: classification score
timeFrame: February 1, 2020 to September 30, 2020
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: CHGUV
city: Valencia
country: Spain
facility: CHGUV
Study officials:
References:
citation: Romero Garcia C, Iftimi A, Briz-Redon A, Zanin M, Otero M, Ballester M, de Andres J, Landoni G, de Las Marinas D, Catala Bauset JC, Mandingorra J, Conca J, Correcher J, Ferrer C, Lozano M. Trends in Incidence and Transmission Patterns of COVID-19 in Valencia, Spain. JAMA Netw Open. 2021 Jun 1;4(6):e2113818. doi: 10.1001/jamanetworkopen.2021.13818.
citation: Briz-Redon A, Iftimi A, Correcher JF, De Andres J, Lozano M, Romero-Garcia C. A comparison of multiple neighborhood matrix specifications for spatio-temporal model fitting: a case study on COVID-19 data. Stoch Environ Res Risk Assess. 2022;36(1):271-282. doi: 10.1007/s00477-021-02077-y. Epub 2021 Aug 18.
Clinical trial NCT04460196: Healthcare Renunciation During the Confinement Period in Connection With the COVID-19 Epidemic in Adult Emergency Departments
Official title: Healthcare Renunciation During the Confinement Period in Connection With the COVID-19 Epidemic in Adult Emergency Departments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergency Medicine
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-07-07
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Person unable to give a non-opposition

Brief summary: Healthcare renunciation is defined as: "Individuals give up care when they do not seek services and health care professionals when they experience a disorder, experience a physical or mental disorder, or when they do not access all of the prescribed care." In 2008, 16.5% of the general French population reported having renounced care. The causes mentioned of the renunciation are mainly the financial difficulties, the deadlines of appointments considered too long, the geographical remoteness. In the department of Sarthe, the rate of cessation of care is estimated at 27.6% over the period from 2014 to 2017.

In the context of the COVID-19 epidemic, containment was applied in France counted from 17 March 2020. The widespread message was "save lives, stay at home". The Ministry of Solidarity and Health has provided health professionals with a circular to adapt the management of patients with chronic disease, requiring elective surgical care and pregnant women.

The decline in activity of general practitioners is estimated at 44% and that of other specialists at 71%. In Paris, visits to the emergency room fell by 45% for adults and 70% for children.

The main risk is the deterioration of the health status of some patients with the worsening of chronic diseases, the discovery of pathologies during episodes of decompensation and the absence of management of serious acute pathologies.

The study aims to assess the importance of giving up care during this period of COVID-19 and in comparison with a study conducted at the University Hospital of Angers and the hospital of Le Mans in 2017.


Eligibility criteria: Inclusion Criteria:

* All adults patients consulting in the emergency department and agreeing to answer the questionnaire

Exclusion Criteria:

* Patient admitted in the emergency department in serious condition (life distress)
* Person unable to consent

Primary outcomes:
measure: rate of patients who gave up consulting in the emergency department
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Le Mans
country: France
facility: CH Le Mans
Study officials:
References:
Clinical trial NCT06696196: Validation of Sleep Monitoring Algorithm Based on Smart Watches
Official title: Validation of Sleep Monitoring Algorithm Based on Smart Watches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: Polysomnography
sleep staging
sleep efficiency
wearable devices
smart watches
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-11-20
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In recent years, wearable devices are booming to enable not only the health monitoring but also the sleep efficiency assessment. To validate the algorithm of sleep staging and efficiency, this study will use a dedicated prototype to acquire photoplethysmogram (PPG), body movements, skin temperature, and galvanic skin response by recruiting 35 subjects. PSG will be used as gold standard for statistical analysi.

Detailed description: Sleep efficiency has a great impact on the performance of work and learning during the day. If persons lack of sleep for a long time, they might be prone to memory loss and emotional instability. Traditionally, polysomnography (PSG) has been proved as golden results to assess the sleep efficiency. However, to accomplish the assessment, subjects are asked to sleep in a certified sleep laboratory or a sleep centers for nights. Under the supervision of nurses, subjects are put many adhesive electrodes on the body and connect wires to PSG, which causes discomfort. In recent years, wearable devices are booming to enable not only the health monitoring but also the sleep efficiency assessment. To validate the algorithm of sleep staging and efficiency, this study will use a dedicated prototype to acquire photoplethysmogram (PPG), body movements, skin temperature, and galvanic skin response by recruiting 35 subjects. PSG will be used as gold standard for statistical analysi.

Eligibility criteria: Inclusion Criteria:

1. Forty male or female subjects are recruited from those visiting Department of Medicine for health check up
2. Subjects aged 20 to 65

Exclusion Criteria:

1. Refuse to participate
2. Arrhythmia
3. Active infection
4. Active neurologic event
5. Shift worker
6. Substance abuse
7. Fitted with implantable medical electronics, such as cardiac pacemakers and defibrillators

Primary outcomes:
measure: sleep stages derived from smartwatch
timeFrame: 12 months
Secondary outcomes:
measure: sleep efficiency derived from smartwatch
timeFrame: 12 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Internal Medicine
name: Pei-Lin Lee, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06421896: Motivational Enhancement Therapy's Impact on d COPD Outcomes in Geriatric Patient
Official title: Exploring the Motivational Enhancement Therapy's Impact on Motivation, Resilience, Anxiety Reduction, and COPD Outcomes in Geriatric Patient
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Motivational Enhancement Therapy (MET) is a systematic intervention that focuses on eliciting and strengthening a person's intrinsic motivation to change. MET is rooted in motivational interviewing principles, emphasizing empathy, autonomy, and the evocation of the patient's own motivations for change. The therapy typically involves several sessions where therapists help patients identify personal goals, explore ambivalence towards change, and develop actionable plans to achieve their desired outcomes.

Detailed description: Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of morbidity and mortality worldwide, particularly among the elderly. Managing COPD effectively in geriatric patients requires addressing not only the physiological aspects of the disease but also the psychological and motivational factors that can influence treatment adherence and overall well-being. Motivational Enhancement Therapy (MET) is a counseling approach designed to help individuals enhance their motivation to change and engage in healthier behaviors. This study explores the impact of MET on motivation, resilience, anxiety reduction, and COPD outcomes in geriatric patients.

Eligibility criteria: Inclusion Criteria:

* more than 60 years

Exclusion Criteria:

* more than 80 years

Primary outcomes:
measure: COPD geriatric patients who entered motivational Enhancement Therapy will demonstrate a higher score in resilience scale ( ( total score range from 15 to 75, a higher score of more than 50)than those who not entered
timeFrame: three months
Secondary outcomes:
measure: OPD geriatric patients who entered motivational Therapy will demonstrate a lower score in anxiety inventory ( total score range from 10 to 50, a lower score of more than 20)than those who not entered
timeFrame: three months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university
state: Al Iskandariyah
Study officials:
References:
Clinical trial NCT01009996: Efficacy Study of Kissing Drug-Eluting Balloons in Coronary Bifurcation Lesions
Official title: Kissing Drug-Eluting Balloons After Bare Metal Stenting of Coronary Bifurcation Lesions.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Coronary Artery Disease
Bifurcation Lesions
Keywords: Coronary bifurcation lesions
Lead sponsor: Ospedale Santa Maria Goretti
Sponsor class: OTHER
First posted: 2009-11-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All coming

Brief summary: KISSING DEBBIE's aim at assessing angiographic and clinical outcomes of provisional treatment of coronary bifurca6on lesions according to TAP sten6ng with BMS and final kissing DEB


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* De novo major bifurca6on lesion of the left coronary artery (LAD-D; LCX-OM)
* RVD 2.25-4.0 mm

Exclusion Criteria:

* LMCA
* AMI within 48 hours
* Limited compliance with 3-month dual antiplatelet therapy

Primary outcomes:
measure: Late lumen loss on both MV and SB
timeFrame: 9 months
Secondary outcomes:
measure: Procedural success (residual stenosis <20% on MV and <50% on SB with TIMI flow 3 for both)
timeFrame: immediate
measure: Binary restenosis rate
timeFrame: 9 months
measure: Major adverse cardiac events
timeFrame: 3 months
measure: Major adverse cardiac events
timeFrame: 6 months
measure: Major adverse cardiac events
timeFrame: 9 months
measure: Major adverse cardiac events
timeFrame: 12 months
Other outcomes:
Locations:
city: Latina
country: Italy
facility: UOC Emodinamica e Cardiologia Interventistica - Ospedale Santa Maria Goretti
Study officials:
References:
citation: Sgueglia GA, Todaro D, Bisciglia A, Conte M, Stipo A, Pucci E. Kissing inflation is feasible with all second-generation drug-eluting balloons. Cardiovasc Revasc Med. 2011 Sep-Oct;12(5):280-5. doi: 10.1016/j.carrev.2010.12.001. Epub 2011 Jan 26.
Clinical trial NCT02806596: Bispectral Index to Guide Intubation in Pediatric Anesthesia
Official title: Use of Bispectral Index to Guide Intubation During Sevoflurane Anesthesia in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This prospective study aimed to determine the minimal level of Bispectral index needed for quality laryngoscopy before ear, nose and throat surgery in children.

Detailed description: * Children will received intra-rectal premedication based on midazolam 0.4mg
* Children will be monitored according to standard guidelines
* One blinded anesthesiologist will be in charge of anesthesia induction and the other one will be in charge of data collection (end tidal sevoflurane concentration, sevoflurane minimal alveolar concentration, bispectral index) and guidance of induction according to the predetermined bispectral index (up and down allocation)

Eligibility criteria: Inclusion Criteria:

* American Society Anesthesiology physical status classification system :1 or 2
* scheduled ear, nose and throat surgery in a one day program
* oral intubation required

Exclusion Criteria:

* parents refusal
* recent respiratory infection
* epilepsy
* suspected difficult intubation

Primary outcomes:
measure: laryngeal conditions of intubation
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: