louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02681380: Impact of a Relation Training on Empathy of Medical Student
Official title: Impact of a Relation Training, Balint-like, on Empathy of Medical Student in the 4th Year.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Empathy
Keywords: simulated patient
Balint
empathy
medical student
Lead sponsor: University of Paris 5 - Rene Descartes
Sponsor class: OTHER
Collaborators: name: University Paris 7 - Denis Diderot
name: University of Paris 13
First posted: 2016-02-12
Enrollment: 352
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Empathy is an important skill to learn for medical student. However, learning empathy remain difficult. The investigators aim was to assess the efficacy of a specific training, Balint like, on the empathy abilities of medical students in the 4th year. The investigators planned a randomized controlled trial in 3 universities.


Eligibility criteria: Inclusion Criteria:

* Medical student in the 4th year

Exclusion Criteria:

* None

Primary outcomes:
measure: Care
timeFrame: Two weeks after the last session
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Paris 5
name: Philippe Jaury
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buffel du Vaure C, Lemogne C, Bunge L, Catu-Pinault A, Hoertel N, Ghasarossian C, Vincens ME, Galam E, Jaury P. Promoting empathy among medical students: A two-site randomized controlled study. J Psychosom Res. 2017 Dec;103:102-107. doi: 10.1016/j.jpsychores.2017.10.008. Epub 2017 Oct 17.
Clinical trial NCT00688480: Do Xanthine Oxidase Inhibitors Reduce Both Left Ventricular Hypertrophy and Endothelial Dysfunction in Cardiovascular Patients With Renal Dysfunction?
Official title: Do Xanthine Oxidase Inhibitors Reduce Both Left Ventricular Hypertrophy and Endothelial Dysfunction in Cardiovascular Patients With Renal Dysfunction?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Disease
Left Ventricular Hypertrophy
Keywords: CKD
LVH
Echo LVH
Chronic Stage 3
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2008-06-03
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cardiovascular related disease is the main cause of death in patients with kidney disease, and "oxidative stress" is thought to be a major contributor by promoting thickening of the heart muscle and stiffening of the arteries. Allopurinol, a drug used safely in the treatment of gout for many years, has been found to dramatically reduce "oxidative stress". It is therefore hoped that it also reduce the thickened heart muscle and stiffened arteries. If it did, it is likely to reduce the appallingly high cardiac death rate in this group of kidney disease patients.


Eligibility criteria: Inclusion Criteria:

* CKD stage 3
* Echo LVH

Exclusion Criteria:

* Known heart failure
* Patients already on Allopurinol
* Patients with gout
* Patients with hepatic disease
* Contraindications to MRI, including severe claustrophobia
* Current immunosuppressive therapy, chlorpropamide, theophylline, 6- mercaptopurine
* Malignancy or other life threatening disease
* Pregnancy or lactating women
* Patients unable to provide written consent

Primary outcomes:
measure: Primary objective is to see if Allopurinol reduces left ventricular hypertrophy (LVH) in this group of CKD patients
timeFrame: 9 months
Secondary outcomes:
measure: Secondary objective is to see if Allopurinol reduces endothelial dysfunction in this group of CKD patients
timeFrame: 9 months
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Division of Medicine and Therapeutics, Ninewells Hospital & Medical School
Study officials:
affiliation: University of Dundee
name: Allan D Struthers, BSc, MD, FRCP, FESC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05140980: Sexuality Education: Knowledge of Women Aged 18 to 25
Official title: Sexuality Education: Knowledge of Women Aged 18 to 25
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sexual Behavior
Keywords: Sexuality
knowledge
young women
education
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women aged 18 to 25

Brief summary: Information, education and communication concerning sexual health are essential for enable to do informed and responsible decisions about it.

In France, education for sexuality in schools still remains unequal and is considered as unsuited to the realities of young people. This observation led to the development of a national sexual health strategy. One of the challenges is to promote and enhance the implementation of interdisciplinary sexuality education. Midwives are and should be involved in the issue of sexuality.

Detailed description: The aim of the study is to describe knowledge concerning sexuality of young women aged 18 to 25.

Eligibility criteria: Inclusion Criteria:

* female
* aged 18 to 25 years old
* with or without sexual activity
* agreeing to participate in the study

Exclusion Criteria:

- none

Primary outcomes:
measure: Knowledge about clitoris
timeFrame: Day 0
Secondary outcomes:
measure: Sexual health well-being
timeFrame: Day 0
Other outcomes:
Locations:
city: Reims
country: France
facility: Cabinet de Sage Femme Liberale
state: Grand-Est
Study officials:
References:
Clinical trial NCT00776880: Does American Society of Anesthesiologists (ASA) Physical Status Scale Enough in Patients Assessment
Official title: Reevaluating the American Society of Anesthesiologists (ASA) Physical Status System in Patients Assessment and Compared With a New Scale of Physical-psycho-social Gauge Raised by Our Institution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elective Surgery
Keywords: Surgical operation
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2008-10-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing surgical operations

Brief summary: American Society of Anesthesiologists (ASA) physical status scale has been used worldwide for assessing the status of patients before operation. However, merely the value of ASA scale did not give enough information of patients to determine their prognosis and improvement of outcomes. Since 1948, World Health Organization (WHO) defined health as the state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. Therefore, the investigators hypothesized that the ASA scale only was needed to be modified and should be replaced by a comprehensive gauge to evaluate the status of patients in depth. Based on this thought, the investigators used a new system, i.e., physical-psycho-social (PPS) scale, to assess the overall state before surgical procedures.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective surgical operation
* Age from 18-65 years

Exclusion Criteria:

* Age \< 18 years or \> 65 years
* Not willing to participate in this study
* Patients from emergency department

Primary outcomes:
measure: Time of recovery
timeFrame: Six months after operation.
Secondary outcomes:
measure: Intraoperative consumption of drugs
timeFrame: 1 day after operation
measure: Incidence of side events
timeFrame: 72 hours after operation
measure: Hospitalization days
timeFrame: From 0 min after operation to the time duration of discharge home, this measure would be varied in different patients
measure: Psychological state
timeFrame: Six months after operation
measure: Life quality
timeFrame: Six months after operation
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03432962: Brand Level Nutrient Information Compared to Generic Food Codes
Official title: Brand Level Nutrient Information Compared to Generic Food Codes: Impact on Results From Dietary Recalls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diet Records
Diet Surveys
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: British Medical Research Council
First posted: 2018-02-14
Enrollment: 61
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In order to reach a broad range of individuals, adult participants from both the University of Leeds and from a convenience sample of members of the public, were invited to participate in the study via email.

Brief summary: Measuring diet is difficult. This is the first time that brand level foods and nutrient values have been compared with generic food codes to explore the difference this might make to estimated nutrient intakes.

Detailed description: Background Traditional dietary assessment methods lack precision. myfood24 is an online 24-hour dietary assessment tool, aiming to reduce the burden of dietary assessment; providing data entry by participants using automated coding of food items. myfood24 includes a large branded food database.

Objective To assess the effect of using brand level nutrient information compared to generic food codes on estimated nutrient intakes.

Design A 24 hour recall was collected using myfood24, which contains a food and nutrient database of over 40,000 items with both branded and generic foods. Participants freely selected their foods generating the 'free choice recall'. After the online recall was completed, they provided further details of brands consumed. The free choice recalls were recoded forming an 'all branded' and an 'all generic' recall. Estimated nutrient intakes from the three different methods of food coding were compared to assess the impact of brand-level information.

Eligibility criteria: Inclusion Criteria:

* students University of Leeds
* convenience sample of general public
* adults

Exclusion Criteria:

* none defined

Primary outcomes:
measure: Nutrient intakes by food coding
timeFrame: 24hour recall
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Nutritional Epidemiology Group
state: West Yorkshire
Study officials:
References:
Clinical trial NCT04435262: Syncope and Implanted Loop Recorder: the Utility of Remote Monitoring and Patients Centered Setting Alarms
Official title: Syncope and Implanted Loop Recorder: the Utility of Remote Monitoring and Patients Centered Setting Alarms in Real World Setting.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Syncope
Loop Recorder
Remote Monitoring
Keywords: Syncope
Loop Recorder
Remote Monitoring
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population included all patients with unexplained syncope underwent ICM implantation according to current gudelines and followed by conventionally or RM according to the hospital's clinical practice.

Brief summary: Actually, there are few data about the effectiveness of remote monitoring (RM) and patient centered alarms setting in patients with unexplained syncope underwent implanted loop recorder (ILR) monitoring.

The aim of this study is to evaluate the time from onset of first physician's evaluation of asyntomatic ECG events lead to medical treatment in ordinary clinical practice for syncope patients with ILR patients and compare it between patients followed with RM or conventionally with annual in-hospital visits.


Eligibility criteria: Inclusion Criteria

* Patients with unexplained syncope underwent ICM implantation according to current gudelines.

Exclusion Criteria

* Patients do not provied signing Patient Informed Consent Form

Primary outcomes:
measure: Time to medical treatment
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Campania "Luigi Vanvitelli"
Study officials:
References:
Clinical trial NCT02062762: Internet-based Stress Reduction Training for Students
Official title: Internet-based Stress Reduction Training for Students - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Stress
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2014-02-14
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main objective of the current study is to evaluate whether a mindfulness based intervention delivered online can provide an effective resource for increasing psychological well-being among students. In addition, explore potential mechanisms through which the training lead to improvements by means of mediational analyses, with hypothesized variables like positive/negative affect and attention regulation.


Eligibility criteria: Inclusion Criteria:

* current student
* have an active e-mail account
* regular use of the internet

Exclusion Criteria:

* non-Swedish speaking

Primary outcomes:
measure: Psychological well-being
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Depression symptoms
timeFrame: Baseline, Week 8
Other outcomes:
measure: Health-related behaviors
timeFrame: Baseline, Week 8
Locations:
city: Stockholm
country: Sweden
facility: Karolinsk Institute
Study officials:
affiliation: Karolinska Institutet
name: Richard Branstrom, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kvillemo P, Brandberg Y, Branstrom R. Feasibility and Outcomes of an Internet-Based Mindfulness Training Program: A Pilot Randomized Controlled Trial. JMIR Ment Health. 2016 Jul 22;3(3):e33. doi: 10.2196/mental.5457.
Clinical trial NCT03725462: Evaluation of Electrophysiological Signal Measured by Smart Textile CE-marked
Official title: Evaluation of Electrophysiological Signal Measured by Smart Textile CE-marked
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: BioSerenity
Sponsor class: INDUSTRY
First posted: 2018-10-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The aim is to evaluate the performance of Cardioskin and Neuronaute, two connected medical devices CE-marked, manufactured by Bioserenity.

It's an open monocentric comparative clinical study, where subjects will test the Cardioskin device and/or the Neuronaute device.

Detailed description: With this study evulating the performance of two wireless, connected device of electrophysiological signal monitoring. The Cardioskin monitors electrocardiogram signal. The Neuronaute monitors electroencephalogram, electromyogram and electrocardiogram.

This study will permit to optimize the devices performance.

To the study, subjects of at least 18 years old will test Cardioskin and or Neuronaute device, without randomization.

Eligibility criteria: Inclusion Criteria:

• man or women of at least 18 years old

Exclusion Criteria:

* Injuries or wounds on the body and scalp
* Participant unable to follow the procedure of use, the judgment of the investigator
* Brain surgery that occurred less than a week ago
* Known allergy to silver, polyamide, silicone, synthetic materials
* Sensory disorders that make the subject insensitive to pain
* behavioral problems that make the subject excessively agitated or aggressive;
* Cardiorespiratory disorders that may be aggravated by mild compression of thorax
* Subject equipped with an electrical stimulation device;
* Inappropriate anthropometric parameters to textile sizes
* Clinically detectable or known pain of the subject;
* Current participation in a clinical trial or participation in a previous clinical study including a period of deficiency not yet completed at the time of this clinical trial
* Predisposition to tension headaches (the compression exerted by the cap may in some cases trigger a headache);
* Use of the Cardioskin device for resuscitation or intensive care.
* Participant with defibrillator, vagus nerve stimulator or other high frequency surgical device

Primary outcomes:
measure: Sensor quality validation
timeFrame: 2 month
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: ICM
Study officials:
References:
Clinical trial NCT00481962: Health Economic Assessment of Tygacil® in the Treatment of Secondary Peritonitis in Intensive Care Units (ICUs)
Official title: Health Economic Assessment of Tygacil® in the Treatment of Secondary Peritonitis in Intensive Care Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peritonitis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-04
Enrollment: 180
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: primary care clinical

Brief summary: The main goals of the study are: Assessment of Tygacil's cost-effectiveness; Process cost analysis from a hospital perspective (including length of stay, treatment costs, side effect management costs, costs of monitoring, costs of diagnostic procedures, cost of care (TISS 10 score etc.); Efficacy of Tygacil under usual care conditions (cure rate).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of secondary peritonitis
* Treatment in an ICU
* Patient age \>18 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Cities
country: Germany
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Germany, medinfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00567762: Phase III Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Patients With Vernal Keratoconjunctivitis
Official title: A Randomized, Placebo-controlled, Double-masked Study of 0.1% Tacrolimus(FK506) Ophthalmic Suspension in Vernal Keratoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Keratoconjunctivitis
Conjunctivitis
Keywords: Keratoconjunctivitis
vernal keratoconjunctivitis
FK506
Tacrolimus
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-12-05
Enrollment: 56
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and safety of FK506 ophthalmic suspension on eye symptoms in patients with vernal keratoconjunctivitis

Detailed description: 0.1% FK506 ophthalmic suspension were administered twice-a-day to patients with vernal keratoconjunctivitis in whom treatment with topical anti-allergic agents had been ineffective. The primary efficacy endpoint was the mean change from the baseline (before the treatment)in total score for objective clinical signs at the final observation. The safety of FK506 ophthalmic suspension was also investigated.

Eligibility criteria: Inclusion Criteria:

* Vernal keratoconjunctivitis patients diagnosed by "Guideline of diagnosis and treatment of allergic conjunctival disease"
* Patients with type I reactions defined by skin testing, antibody measurement, etc.
* Age over 6 years old

Exclusion Criteria:

* Subjects receiving systemic administration or subconjunctival injection of corticosteroid or immunosuppressants(ophthalmic and systemic medications) within 2-weeks of initiation of the study
* Subjects needed to wear contact lenses during treatment period on a testing eye
* Subjects complicating an eye infection

Primary outcomes:
measure: Mean change from the baseline (before the treatment) in total score for objective clinical signs at the final observation
timeFrame: 4 weeks
Secondary outcomes:
measure: Mean change from the baseline in score for objective clinical signs and the score for each objective clinical sign
timeFrame: Week 1, 2 and 4
measure: Subjective symptom score (Visual Analog Scale)
timeFrame: 4 weeks
measure: The improvement rate of subjective symptoms
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ehime
country: Japan
city: Hokkaido
country: Japan
city: Kagoshima
country: Japan
city: Kochi
country: Japan
city: Miyazaki
country: Japan
city: Osaka
country: Japan
city: Tochigi
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_CHAIR
References: