louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03485781: Propofol-induced EEG Changes in Hypoxic Brain Injury
Official title: Assessment of Hypoxic Brain Injury by Analyzing Propofol-induced EEG Changes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxic-Ischemic Encephalopathy
Cardiac Arrest
Keywords: EEG
Intensive Care
Propofol
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
name: Helsinki University Central Hospital
name: Cerenion Oy
First posted: 2018-04-02
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients admitted to intensive care in the study units.

Brief summary: PROPEA3 is a prospective observational study investigating the recovery of propofol-induced EEG slow-wave activity and its association with neurological outcome after cardiac arrest.

Detailed description: PROPEA3 is a prospective observational study investigating the recovery of propofol-induced EEG slow-wave activity and its association with neurological outcome after cardiac arrest. Comatose adult patients admitted to intensive care unit (ICU) after cardiac arrest are included. Patients with previous neurological disease expected to affect substantially EEG are excluded. The patients' relatives are asked for an informed written consent to participate. In the intensive care, the patients are sedated using continuous infusion of propofol while receiving temperature management/hypothermia treatment following the ICUs' common practice. EEG is recorded continuously from the admission to the ICU until 48 hours from the cardiac arrest. EEG slow-wave activity is determined offline by calculating the low-frequency (\<1 Hz) power from the signal. The neurological recovery of the patients is defined 6 months after cardiac arrest from patient documents and/or by phone call to the patient/relative using Cerebral Performance Category. After the follow-up period patient or the relative is also asked to fill a survey (SF-36) to estimate the health and quality of life.

Eligibility criteria: Inclusion Criteria:

* Comatose patients admitted to intensive care after cardiac arrest

Exclusion Criteria:

* Previous neurological disease expected to affect EEG substantially

Primary outcomes:
measure: EEG slow-wave activity
timeFrame: 0-48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: University of Oulu
name: Jukka Kortelainen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kortelainen J, Vayrynen E, Huuskonen U, Laurila J, Koskenkari J, Backman JT, Alahuhta S, Seppanen T, Ala-Kokko T. Pilot Study of Propofol-induced Slow Waves as a Pharmacologic Test for Brain Dysfunction after Brain Injury. Anesthesiology. 2017 Jan;126(1):94-103. doi: 10.1097/ALN.0000000000001385.
Clinical trial NCT04137081: Unwinding Physician Anxiety
Official title: Managing Risk at Its Source: Reducing Clinician Burnout Through Digital Therapeutic Delivery of Mindfulness Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Burnout, Professional
Keywords: Physicians
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test an app-based mindfulness training program to see if it can reduce anxiety and burnout in physicians.

Detailed description: In this study, 50 clinicians will be provided access to the Unwinding Anxiety program. The intervention period will last 3 months and changes in anxiety and burnout along with program engagement will be assessed at baseline, 1 month, and 3 months.

Eligibility criteria: Inclusion Criteria:

* Currently employed as a physician
* Direct patient interaction
* Owns a smartphone
* Endorsed anxiety based on answering yes to following questions:

  1. Do you feel nervous, anxious, or on edge?
  2. Do you feel you worry too much about different things?
* Endorsed willingness to use smartphone app for 10+ minutes/day for 30 days
* Endorsed willingness to complete online surveys

Exclusion Criteria:

* None

Primary outcomes:
measure: Changes in anxiety
timeFrame: 1 month
Secondary outcomes:
measure: Changes in burnout
timeFrame: 1 month
measure: Program engagement
timeFrame: 1 month
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: UMass Worcester
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roy A, Druker S, Hoge EA, Brewer JA. Physician Anxiety and Burnout: Symptom Correlates and a Prospective Pilot Study of App-Delivered Mindfulness Training. JMIR Mhealth Uhealth. 2020 Apr 1;8(4):e15608. doi: 10.2196/15608.
Clinical trial NCT02046681: Monitoring Side Effects Of Pain Medication Prescribing By Emergency Department In Patients Over 65
Official title: Monitoring Side Effects Of Pain Medication Prescribing By Emergency Department In Patients Over 65. The MOSE65 Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pain
Analgesics
Elderly
Keywords: Medication Adherence
Medication Compliance
Medication Therapy Management
Side effects
Analgesics
Emergency Medicine
Home care
Aged
Acetaminophen
codeine
ibuprofen
Oxycodone
Lead sponsor: Azienda Ospedaliera S. Maria della Misericordia
Sponsor class: OTHER
First posted: 2014-01-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: individuals age 65 years or older initiating analgesic treatment po following emergency department visits.

Brief summary: Half of the people over the age of 65 are not functioning at their optimal level because of interference from pain. \> 50% of older adults had taken prescriptions of pain medication beyond a 6-month period. In Emergency Department 80% of visits involving conditions with painful component. The study aims to observe and check side effects of most frequently pain killers prescribing at home to patients over 65 years old after a visit in emergency department.

Detailed description: - observe side effects of pain medications prescribed in emergency department to patient over 65 yo

Eligibility criteria: Inclusion Criteria:

* 65 years or older
* new analgesic treatment po following emergency department visits
* easily reachable by phone

Exclusion Criteria:

* age under 65
* pt may not able to hear, or answer the phone
* pt with a history of dementia
* pt who already takes pain killer, or neuroleptics

Primary outcomes:
measure: To measure side effects of pain medication prescribed by emergency department to patients older 65 years
timeFrame: up to 1 week
Secondary outcomes:
measure: To ascertain the number of patients pain free
timeFrame: 1 month
measure: Measure the number of patients that follow the therapy prescribed
timeFrame: 1 month
Other outcomes:
Locations:
city: Castelfranco Veneto
country: Italy
facility: Castelfranco Veneto Emergency Department
city: Dolo
country: Italy
facility: Dolo Emergency Department
city: Mirano
country: Italy
facility: Mirano Emergency Department
city: Montebelluna
country: Italy
facility: Montebelluna Emergency Department
city: Udine
country: Italy
facility: Emergency Department AOU S.Maria della Midericordia Udine
Study officials:
affiliation: AOU S.Maria della Misericordia Udine
name: Ciro Paolillo, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT03194581: Normoxic Challenges Utility to Evaluate Blood Loss
Official title: Normoxic Challenges Utility to Evaluate Blood Loss Through Cerebral Oxygenation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hemorrhage
Lead sponsor: Centro Hospitalar do Tâmega e Sousa
Sponsor class: OTHER
First posted: 2017-06-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients submitted to surgery with high risk of blood loss

Brief summary: This study will evaluate the impact of repeated normoxic challenges on cerebral oxygenation as a measure of the effect of blood loss on DO2 during surgical procedures.


Eligibility criteria: Inclusion Criteria:

* Elective surgery
* High risk of intraoperative blood loss
* General anaesthesia

Exclusion Criteria:

* Respiratory insufficiency
* Ischemic heart disease
* Stroke
* ASA classification \> 3
* Laparoscopic surgery

Primary outcomes:
measure: Change in cerebral regional oxygen saturation
timeFrame: Before and 3 minutes after normoxic challenges
Secondary outcomes:
Other outcomes:
Locations:
city: Penafiel
country: Portugal
facility: Centro Hospitalar Tâmega e Sousa
state: Porto
Study officials:
References:
Clinical trial NCT03783481: Distress Reduction by Activity Tracking and Activity Enhancement by Mobile Support Group in Oncology
Official title: Distress Reduction by Activity Tracking and Activity Enhancement by Mobile Support Group in Oncology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Mobile Community
Keywords: Breast cancer survivors
mobile community
distress
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 202
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to investigate the effect of the formation of social networks using smartphones can help increase physical activity and reduce stress in survivors after breast cancer treatment surgery.


Eligibility criteria: Inclusion Criteria:

* Stage 0-III breast cancer
* ECOG Performance Status 0
* Patient who underwent surgery for breast cancer
* Patients with their own smartphones and who can use smartphone apps

Exclusion Criteria:

* Breast cancer recurrence or metastasis
* Severe medical illness
* need to Adjubant Chemotherapy

Primary outcomes:
measure: Rate of moderate to severe distress at 6 months
timeFrame: 6months
Secondary outcomes:
measure: total weekly steps at 6 months
timeFrame: 6months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Korea
Study officials:
affiliation: Asan Medical Center
name: Il Yong Chung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02881281: Development of Problem-solving Skills Among Female Adolescents by Application of Social Cognitive Theory in Parent-Child Relationship
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adolescent Girls
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 120
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Adolescence is the most important period of growth for humans. The conflict and disagreement which exists within family relationships will affect the children behaviors. Family relationships are the cause of many problems in adolescents, to develop a training program on problem-solving skills for adolescent girls to change their relationship with their parents.


Eligibility criteria: Inclusion Criteria:

* female secondary schools
* healthy body,
* not having a psychiatric disorder

Exclusion Criteria:

* psychiatric disorder
* not being volunteer to participate in the present study.

Primary outcomes:
measure: Child-Parent Relationship.
timeFrame: 4 month
measure: Constructs of social cognitive theory
timeFrame: 4 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Seyed Taghi Heydari
state: Fars
Study officials:
References:
Clinical trial NCT00170781: Efficacy and Safety of Lumiracoxib 400 mg Once Daily in Acute Flares of Gout
Official title: A 1-Week, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Parallel Trial Comparing Lumiracoxib (400 mg Once Daily) in Patients With Acute Flares of Gout, Using Indomethacin (50 mg Three Times a Day)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Gouty Arthritis
Keywords: Pain, acute gout, arthritis, cyclooxygenase-2 inhibitors, lumiracoxib, indomethacin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to develop our understanding of the efficacy and safety of using lumiracoxib in the treatment of patients with acute gout. This is a multi-center, double-blind, randomized, parallel group study comparing a single daily dose of 400 mg lumiracoxib with the established dose of indomethacin 50 mg taken three times a day in terms of efficacy


Eligibility criteria: Inclusion Criteria:

* Ambulatory cooperative male or female patients of at least 18 years of age
* With an acute attack of gout in 4 joints or less, diagnosed clinically according to the ACR 1977 classification criteria and with an onset within the last 48 hours prior to evaluation. Where more than one joint is involved, the most affected joint should be identified, as the study joint, at baseline and followed throughout the study
* Who present at Baseline with an acute pain intensity of at least moderate.

Exclusion Criteria:

* With an acute attack of gout before the last 48 hours prior to evaluation
* With polyarticular gout involving \> 4 joints
* With rheumatoid arthritis, infectious arthritis, pseudo-gout or other acute inflammatory arthritides.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Pain intensity in the study joint over days 2 to 5 approximately 4h after the first daily dose
Secondary outcomes:
measure: Safety and tolerability profile
measure: Pain intensity in the study joint over the entire treatment period
measure: Patient's and Physician's global assessment of response to therapy
measure: Physician's assessment of tenderness and swelling of study joint
measure: C-reactive protein level
measure: Proportion of patients who discontinued treatment because of a lack of efficacy
measure: Usage of rescue medication
measure: SF-36 and EQ-5D
measure: Physician's assessment of erythema of study joint
Other outcomes:
Locations:
city: Nuernberg
country: Germany
facility: Novartis
city: Basel
country: Switzerland
facility: For Site Information, contact Novartis Pharma AG
state: CH
Study officials:
affiliation: Sponsor GmbH
name: Novartis Pharma AG
role: STUDY_CHAIR
References:
Clinical trial NCT06358781: A Dose-response Study to Validate the Biomarkers for Whole Grain Dietary Intake
Official title: Screening Whole Grain Dietary Intake Biomarkers and Validating the Dose-response Relationship in a Randomized Controlled Study in China.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Disease Prevention
Keywords: Whole grain
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Dose-response validation of whole grain dietary intake biomarkers remains limited, and it is debatable whether these markers could be utilized as classifiers for different levels of whole grain consumption. Because there are significant disparities in genetic background and dietary patterns between Chinese and Western cultures, it is unclear if whole grain dietary intake biomarkers can characterize whole grain consumption in Chinese populations. To address these issues, the current study was designed to evaluate the sensitivity and specificity of potential whole grain markers in a randomized controlled trial, as well as to validate the markers' dose-response relationship, so that they can be used in nutritional epidemiological studies and dietary intake assessments of whole grains.

Detailed description: An acute randomized controlled trial was performed and the total study group is randomly divided into four groups: the amounts of WG wheat flour administered were 0 g, 25g, 50 g and 100 g. Experimental period with a total of 6 days was subdivided into two parts: -5 days to 0 h defined as the run-in period, 0-24 h (after the dose-related test meal), defined as the test day.

Eligibility criteria: Inclusion Criteria:

* Healthy men and women
* age 18-40 years
* BMI 18.5-23.9 kg/m2.

Exclusion Criteria:

* pregnancy or breastfeeding
* vegetarian;
* smokers;
* acute and chronic diseases;
* allergic to wheat;
* frequent nutrients supplement use;
* medication use of antibiotics within 1-month;
* more than 3 kg weight change within 3-month;
* unwillingness to follow dietary restrictions;

Primary outcomes:
measure: whole grain plasma and urine biomarkers discovery and identification
timeFrame: Baseline and 0~24 hours after intervention food intake
Secondary outcomes:
measure: Validate the performance of the potential WG biomarkers.
timeFrame: Baseline and 0~24 hours after intervention food intake
Other outcomes:
measure: Dose-response of WG wheat biomarkers.
timeFrame: Baseline and 0~24 hours after intervention food intake
Locations:
city: Beijing
country: China
facility: Department of Nutrition and Food Hygiene, School of Public Health, Peking University
Study officials:
affiliation: Peking University
name: Yajun Xu
role: STUDY_DIRECTOR
References:
Clinical trial NCT03697681: Protective Effect of Tranexamic Acid on Shedding of the Endothelial Glycocalyx in Patients Undergoing Spinal Fusion Surgery
Official title: Protective Effect of Tranexamic Acid on Shedding of the Endothelial Glycocalyx in Patients Undergoing Spinal Fusion Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Lumbar Spinal Fusion Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 128
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized, Double-Blinded, Placebo-Controlled Trial
Primary purpose: PREVENTION

Brief summary: The aim of this study was to determine whether the administration of tranexamic acid in patients undergoing lumbar spinal fusion surgery can inhibit damage in endothelial glycocalyx layer. As a prospective double blinded randomized placebo-controlled trial, the investigators detect and compare the changes in concentrations of serum syndecan-1 and heparan sulfate before and after surgery.


Eligibility criteria: Inclusion Criteria:

* Adult patients with between 30 and 80 years scheduled for posterior lumbar spinal fusion surgery.

Exclusion Criteria:

* emergency surgery
* patients unable to make their own decisions, illiterate, foreigners
* Allergy / hypersensitivity to Tranexamic acid
* Current or past history or thrombosis / thromboembolism
* patients who are taking oral contraceptives
* Patients with renal insufficiency (eGFR 60 ml / min / 1.73 m 2 or less)
* Patients receiving anticoagulants
* pregnant and lactating women

Primary outcomes:
measure: base blood concentration of syndecan-1, heparan sulfate
timeFrame: within 1 hour before surgery(base concentration)
measure: blood concentration of syndecan-1, heparan sulfate at the end of the surgery
timeFrame: within 5 minutes after the end of surgery (when thd surgical drape is removed)
measure: blood concentration of syndecan-1, heparan sulfate at 2 hours after surgery
timeFrame: 2 hours after the end of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT04417881: EVALUER L'IMPACT PREDICTIF DU SCORE MEESSI POUR LA STRATIFICATION DU RISQUE DES PATIENTS ADMIS POUR INSUFFISANCE CARDIAQUE AIGUE DANS LES STRUCTURES D'URGENCES
Official title: EVALUER L'IMPACT PREDICTIF DU SCORE MEESSI POUR LA STRATIFICATION DU RISQUE DES PATIENTS ADMIS POUR INSUFFISANCE CARDIAQUE AIGUE DANS LES STRUCTURES D'URGENCES (ICA-MEESSI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acurate Heart Failure
Keywords: caring
emergency
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 367
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: Patient admitted to emergencies with suspicion of ICA

Brief summary: Our primary purpose is to assess MEESSI score in predicting mortality and readmission of patients managed for acute heart failure (AHF) in Emergency Department.

European Society of Cardiology recommend risk stratification for patients with AHF. MEESSI score is not prospectively validated out of Spain.


Eligibility criteria: Inclusion Criteria:

* Major patient
* Patient admitted to emergencies with suspicion of ICA according to the clinical intuition of the emergency doctor after interrogation, clinical examination, biology and imaging
* Patient with health insurance
* Subject who accept to participate in the research

Exclusion Criteria:

* Patient who refuse to participate in the study
* Patient with coronary syndrome with ST segment elevation
* Other diagnosis of dyspnea
* Persons deprived of their freedom or under the protection of justice
* Persons under guardianship or curatorship
* Impossibility of giving the patient informed information
* Pregnant woman

Primary outcomes:
measure: MEESSI score
timeFrame: 30 days
Secondary outcomes:
measure: Re-admission rate
timeFrame: 30 days
measure: Mortality rate
timeFrame: 30 days
measure: Sensitivity
timeFrame: 30 days
Other outcomes:
Locations:
city: Besançon
country: France
facility: Hôpital Jean Minjoz
city: Cahors
country: France
facility: Centre Hospitalier Jean Rougié
city: Colmar
country: France
facility: Hôpitaux Civils de Colmar
city: Haguenau
country: France
facility: CH Haguenau
city: Montbrison
country: France
facility: Centre Hospitalier Forez
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nancy
country: France
facility: CHU de Nancy
city: Paris
country: France
facility: CHU Pitié Salpetrière
city: Reims
country: France
facility: CHU de Reims
city: Remiremont
country: France
facility: CH Remiremont
city: Sarreguemines
country: France
facility: Hôpital Robert Pax
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse
city: Trévenans
country: France
facility: Hôpital Nord Franche Comté
Study officials:
References: