louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01424072: Auriculotherapy as a Coping Strategy in Professional Nursing
Official title: Applicability of Auriculotherapy as a Strategy for Stress and Coping in Nursing Professionals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stress, Psychological
Coping Behavior
Keywords: stress psychological
coping behavior
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-08-26
Enrollment: 75
Sex: ALL
Minimum age (years): 23
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial aimed at evaluating the auriculotherapy as coping strategies in 75 nursing professionals in a University Hospital.

Detailed description: There is consensus that psychological and social factors can lead to physical health problems of individuals and coping strategies in stressful situations may be crucial for the mental, physical and social development of people. Taking care of professionals who provide health services is a key strategy, since good results depend on the service, especially in work teams healthy and, therefore, able to promote the humanization of service.

Eligibility criteria: Inclusion Criteria:

* Average and high score by the List of Stress Symptoms
* Voluntary participation in the study
* Availability of time for submission to the sessions

Exclusion Criteria:

* Pregnancy
* Medical license or vacation during the period
* Low score of stress

Primary outcomes:
measure: Coping Strategy: Domain Social Support(After 60 Days)
timeFrame: after 60days
measure: Coping Strategy: Distancing Domain
timeFrame: after 75 days
measure: Coping Strategy: Social Support Domain
timeFrame: after 60 days
Secondary outcomes:
measure: Stress Scale
timeFrame: after 60 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Universitário de São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Leonice FS Kurebayashi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04381572: The Impact of High Fidelity Simulation on Stress Level in Medical Students.
Official title: The Impact of High Fidelity Simulation on Stress Level in Medical Students.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress, Physiological
High Fidelity Simulation Training
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2020-05-11
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Medical faculty students (fifth and sixth year) scheduled to undergo high fidelity medical simulation as a part of standard scholastic program.

Brief summary: High fidelity simulation (HFS) is an established method of training in various fields of medicine, especially emergency medicine, anesthesiology and intensive therapy. One of the benefits of HFS as an educational tool is the protective environment, where the risk of error do not bring harm to the patients.

It is proven that HFS is successful in acquisition of new knowledge and skills and may facilitate positive behavioral change in medical students. However, this education method may cause elevated stress levels as well as other physiological reactions. Other than sympathetic nervous system reactions such as heart rate and blood pressure, there are a few laboratory stress level markers such as cortisol, alpha-amylase, testosterone and secretory immunoglobulin A. Our aim was to evaluate the change of stress level induced by high-fidelity simulation in medical students.


Eligibility criteria: Inclusion Criteria:

* willingness to take part in the study

Exclusion Criteria:

* pregnancy,
* active infections
* diseases of immune system
* metabolic or endocrine disturbances
* current use of any medication (except for oral contraceptives)

Primary outcomes:
measure: Α-amylase activity in saliva [U/ml]
timeFrame: 120 minutes
measure: Secretory immunoglobulin class A concentration in saliva [ug/ml]
timeFrame: 120 minutes
measure: Cortisol concentration in saliva [ng/ml]
timeFrame: 120 minutes
measure: Testosterone concentration in saliva [pg/ml]
timeFrame: 120 minutes
measure: Total protein concentration [mg/ml]
timeFrame: 120 minutes
Secondary outcomes:
measure: Heart rate [bpm]
timeFrame: 120 minutes
measure: Blood pressure [mmHg]
timeFrame: 120 minutes
measure: Saturation [%]
timeFrame: 120 minutes
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1
state: Silesia
Study officials:
References:
Clinical trial NCT01316172: Consultation in the Emergency Department
Official title: A Prospective, Randomized Controlled Study Demonstrating a Novel, Effective Model of Communication Among Physicians: The 5 Cs of Consultation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Keywords: consultation
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2011-03-16
Enrollment: 43
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study intends to evaluate consultation in the Emergency Department. The purpose is to demonstrate that standardizing communication in the Emergency Department may lead to improved consultation.


Eligibility criteria: Inclusion Criteria:

* Emergency medicine residents (PGY1-5)

Exclusion Criteria:

* Did not want to partake in the study

Primary outcomes:
measure: Consultation effectiveness as measured by global rating scale
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Consultation effectiveness as determined by a Checklist rating
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois-Chicago
state: Illinois
Study officials:
References:
citation: Kessler CS, Afshar Y, Sardar G, Yudkowsky R, Ankel F, Schwartz A. A prospective, randomized, controlled study demonstrating a novel, effective model of transfer of care between physicians: the 5 Cs of consultation. Acad Emerg Med. 2012 Aug;19(8):968-74. doi: 10.1111/j.1553-2712.2012.01412.x.
Clinical trial NCT06422572: Tissue Kallikrein Protect Against Ischemic Stroke
Official title: The Role of Tissue Kallikrein - Bradykinin System Targeting the Protection of Neurovascular Units in Ischemic Areas of Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Ischemic
Keywords: Stroke
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2024-05-21
Enrollment: 8602
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Control population in the previous stroke case-control study;
2. The CHD case-control population in the previous study;
3. The population in the community cross-sectional study of the previous study.

Brief summary: The results of previous studies were used to assess the causal association between TK levels and stroke occurrence at 5 and 12 years of follow-up, respectively.

Detailed description: Analyze the data of a 5-year follow-up on 2115 control individuals from the case-control study of the previous research. We completed the 5-year follow-up on this group in 2016 (whether they had a stroke, whether they are alive, and the cause of death).

Conduct a 12-year follow-up on 6487 community individuals from the previous study (whether they had a stroke within 12 years, whether they are alive, and the cause of death). We collaborated with the hospital platform's computer center to conduct follow-up through AI questionnaire surveys, followed by supplementing AI questionnaire data with telephone questionnaire surveys for those lost to follow-up.

Utilize R language R Studio 4.11 for statistical analysis and plotting. Evaluate the distribution of TK levels in the control group and its relationship with the 10-year predicted risk of stroke and the predictive role for stroke events within 5 years.

Evaluate the distribution of TK levels in the community group and its relationship with the 10-year predicted risk of stroke and the predictive role for stroke events within 12 years.

Eligibility criteria: Inclusion Criteria:

* 1) Control population in the previous stroke case-control study;
* 2) The CHD case-control population in the previous study;
* 3) The population in the community cross-sectional study of the previous study.

Exclusion Criteria:

* Stroke patient

Primary outcomes:
measure: Incidence of Stroke
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: QIN Zhang, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03102372: Preservation of Fat Free Mass During Weight Loss
Official title: Preservation of Fat Free Mass During Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Loss
Keywords: FFM
VLCD
exercise
Protein
Obesity
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Orkla Health
name: Toyota-Fonden
name: Tømmerhandler Vilhelm Bangs Fond
First posted: 2017-04-05
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized single blinded, controlled intervention trial
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, we aimed to examine the effect of whey protein supplementation given before night sleep on Fat Free Mass (FFM) preservation during a 4 wk period on Very Low Caloric Diet (VLCD).

Half of the participants underwent a 4 week VLCD and walking program, while the other half underwent a 4 week VLCD, walking program and had an additional protein supplement before each night sleep.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (kg/m\^2) \> 28
* Age between 18 and 55 years

Exclusion Criteria:

* Participation in regular resistance-, aerobic- or anaerobic training (\>1 h/wk within the last 3 month before intervention start)
* Diabetes Physical disabilities that would hinder completion of the walking program.

Primary outcomes:
measure: Fat Free Mass
timeFrame: Change from baseline to after the 4 week intervention period
Secondary outcomes:
measure: Nitrogen balance
timeFrame: Change in nitrogen content from baseline to day 7 and 28 of the intervention period
measure: Oral glucose tolerance test
timeFrame: Change from baseline to after the 4 week intervention period
measure: Fitness level
timeFrame: Change from baseline to after the 4 week intervention period
measure: Blood pressure
timeFrame: Change from baseline to after the 4 week intervention period
measure: Fat mass
timeFrame: Change from baseline to after the 4 week intervention period
measure: waist circumference
timeFrame: Change from baseline to after the 4 week intervention period
measure: Performance test
timeFrame: Change from baseline to after the 4 week intervention period
Other outcomes:
Locations:
Study officials:
affiliation: Aarhus University, Department for Public Health, Section for Sport Science
name: Mette Hansen, Lector
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00516672: Phase I Study of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors
Official title: A Phase I, Open-Label, Multiple Dose of Pazopanib Alone and In Combination With Lapatinib in Japanese Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoma, Renal Cell
Keywords: lapatinib,
cancer
pharmacokinetics,
safety,
pazopanib,
Japanese patients,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-08-15
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a two part phase I study in Japanese patients that will determine the safety, tolerability and pharmacokinetics of pazopanib monotherapy and of pazopanib in combination with lapatinib.


Eligibility criteria: Inclusion criteria:

* Signed informed consent.
* Histologically or cytologically confirmed diagnosis of advanced solid tumor.
* Women and men with potential to have children must be willing to practice acceptable methods of birth control during the study.
* ECOG performance status of 0 or 1.
* Adequate bone marrow reserve and hepato-renal function.
* Able to swallow and retain oral medication.
* For combo part, left ventricular ejection fraction within normal range or above 50%.

Exclusion criteria:

* Prior treatment with pazopanib, and with lapatinib for combo part.
* Clinically significant gastrointestinal abnormalities.
* Sevier diseases or conditions other than cancer.
* Poorly controlled hypertension.
* Use of warfarin for therapeutic anticoagulation.
* Use of other anti-angiogenesis agents, and other ErbB inhibitors for combo part.
* Unresolved and/or unstable toxicities
* Pregnant or lactating females

Primary outcomes:
measure: Safety and tolerability
timeFrame: before and after taking the study medications
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: over a 24 hour period
measure: Tumor response
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: GSK Investigational Site
city: Saitama
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Inada-Inoue M, Ando Y, Kawada K, Mitsuma A, Sawaki M, Yokoyama T, Sunakawa Y, Ishida H, Araki K, Yamashita K, Mizuno K, Nagashima F, Takekura A, Nagamatsu K, Sasaki Y. Phase 1 study of pazopanib alone or combined with lapatinib in Japanese patients with solid tumors. Cancer Chemother Pharmacol. 2014 Apr;73(4):673-83. doi: 10.1007/s00280-014-2374-3. Epub 2014 Jan 24.
Clinical trial NCT05269472: Trigeminal Neuralgia Electrophysiology
Official title: Trigeminal Evoked Responses to Improve Rhizotomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Trigeminal Neuralgia
Keywords: Trigeminal Neuralgia
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults of 18 years or older who are scheduled to undergo percutaneous rhizotomy for facial pain

Brief summary: The study intervention is to perform standard somatosensory evoked responses limited to the face during rhizotomy procedures of the gasserian ganglion (trigeminal ganglion) for the treatment of trigeminal neuralgia. The evoked responses will be measured at two locations before and after the clinical rhizotomy including: the standard contralateral scalp (EEG) and at the gasserian ganglion through an FDA-approved recording electrode.


Eligibility criteria: Inclusion Criteria (TGN):

* Adults of 18 years or older
* Scheduled to undergo percutaneous rhizotomy for facial pain

Exclusion Criteria (TGN):

* Facial pain of unclear origin (i.e. not clearly TGN pain)
* Rhizotomy procedure canceled

Inclusion Criteria (Healthy controls)

* Adults of 18 years or older

Exclusion Criteria (Healthy Controls)

* Diagnosis or history of facial pain such as TMD or TGN
* History of migraine
* History of any functional pain disorder: fibromyalgia, IBS, CRPS
* Recent chronic pain (within last month)
* Unwilling to participate for two hours in lab
* Current acute pain

Primary outcomes:
measure: Determine the feasibility of measuring trigeminal somatosensory evoked potentials to improve personalized mapping during percutaneous rhizotomy
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: David Darrow
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05366972: Measuring the Morphological Characteristics of Thoracolumbar Fascia in Low Back Pain
Official title: Evaluation of Morphological Features of Thoracolumbar Fascia by Ultrasonography in Patients With Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-05-10
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Recently, it has been reported that the thoracolumbar fascia may play a role in the pathophysiology of chronic low back pain.There is still no standard method for imaging and analyzing the thoracolumbar fascia.The aim of this study is to advance the understanding of the role of the thoracolumbar fascia in chronic low back pain as well as to advance the analysis methods.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* Patients with low back pain for more than 6 months
* Healthy volunteers

Exclusion Criteria:

* Previous low back or back surgery
* Uncontrolled Diabetes Mellitus
* Mental retardation
* Metabolic disorders

Primary outcomes:
measure: fascia thickness
timeFrame: 20 minutes
Secondary outcomes:
measure: CSA
timeFrame: 20 minute
measure: VAS
timeFrame: 20 minutes
measure: ODİ
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Training and Research Hospital
Study officials:
affiliation: Bursa Yuksek Ihtisas Training and Research Hospital
name: Burcu Metin Ökmen, Assoc. PhD.
role: STUDY_CHAIR
References:
citation: Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.
Clinical trial NCT03058172: Study of Olfaction / Vision Interactions in Expert and Novice Populations
Official title: Study of Olfaction / Vision Interactions in Expert and Novice Populations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this research project is to better understand the reciprocal influence of visual and olfactory systems on cerebral activity evoked by odors and visual stimuli. Given the importance of olfacto-visual learning in expert situations, the degree of expertise in olfaction will also be considered. In addition, the investigators will try to better understand the differences between expert and non-expert populations in olfaction through different levels of approach: sensory, genetic and cerebral. To achieve this, the investigators will use psychophysical tests, genetic analyzes and a non-invasive technique, functional magnetic resonance imaging (fMRI) to measure the brain activity of human subjects - novices or experts in olfaction - in response to different visual and olfactory stimuli.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* men and women, aged 18-85 years old
* subjects with social security cover
* expertise in olfaction for half of the subjects (60)

Exclusion Criteria:

* subjects younger than 18 and older than 85
* subjects with contraindications to fMRI, i.e. with pacemaker / insulin pump / metal prosthesis / intracerebral clip / neurosensory stimulator / implantable defibrillator / cochlear implants / ferromagnetic ocular or cerebral foreign body close to the nerve structures / ventriculoperitoneal neurosurgical bypass valves / braces and other non-removable metallic dental device / claustrophobic, non-cooperating or agitated subjects.
* pregnant or breastfeeding women
* subjects with known olfactory disorder
* subjects with known neurological disorder

Primary outcomes:
measure: Brain activity
timeFrame: During the 2-hour testing session (one session per participant)
Secondary outcomes:
measure: Genotyping
timeFrame: Sampling during the 2-hour testing session (one session per participant), analyses within 6 years after sampling
measure: Olfactory abilities
timeFrame: During the 2-hour testing session (one session per participant)
measure: Perception
timeFrame: During the 2-hour testing session (one session per participant)
measure: Response times
timeFrame: During the 2-hour testing session (one session per participant)
Other outcomes:
Locations:
city: Caluire et Cuire
country: France
facility: Infirmerie Protestante
Study officials:
affiliation: Infirmerie Protestante
name: Frédéric FAURE, MD
role: PRINCIPAL_INVESTIGATOR
References: