louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06907823: Comparison of Sevoflurane and Propofol on ANI
Official title: Comparison of Sevoflurane and Propofol on ANI in Patients Undergoing General Anesthesia: a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Propofol
Sevoflurane
Analgesia Nociception Index
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to compare the effect of sevoflurane and propofol on analgesia nociception index(ANI) in patients undergoing general anesthesia. The main question it aims to answer is whether propofol anesthesia results in lesser ANI change to a nociceptive stimulation compared to sevoflurane.

Detailed description: Patients will be allocated to either propofol or sevoflurane group. Nociceptive event will be defined as long-lasting tetanic stimulation, square-wave, duration of 30 seconds , amplitude of 50mA, frequency of 50 Hz. analgesia nociception index value and hemodynamic parameters will be recorded 1-minute before and after nociceptive event.

Eligibility criteria: Inclusion Criteria:

* American society of anesthesiologists physical status class I or II

Exclusion Criteria:

* history of drugs that can affect the central nervous system and autonomic nervous system, such as anticholinergics, betablockers, antidepressants..etc.
* history of allergic reaction to sevoflurane and/or propofol
* history of and/or family history of malignant hyperthermia
* neurodegenerative disorder
* psychiatric disorder
* arrhythmia
* diabetes mellitus
* drug abuse history

Primary outcomes:
measure: analgesia nociception index change
timeFrame: During anesthesia period
Secondary outcomes:
measure: Hemodynamic change
timeFrame: During anesthesia period
measure: Hemodynamic change
timeFrame: During anesthesia period
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02143323: A Clinical Study to Explore Biomarkers for Drug-induced Liver Injury (DILI)
Official title: A Clinical Study to Evaluate the Effect of Glutathion S-transferase Polymorphism on Pharmacokinetics/Pharmacodynamics After Multiple Administration of Amoxicillin/Clavulanate and Explore Biomarkers for Drug-induced Liver Injury (DILI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: GST, DILI, biomarker
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-05-21
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study has an open-label, one-sequence, multiple drug administration design. The purpose of this study is as follows;

* To evaluate the change of liver function according to glutathione s-transferase (GST) genotype after the multiple administration of amoxicillin/clavulanate.
* To evaluate the intrinsic metabolite, human leukocyte antigen (HLA) genotype, and microRNA (miRNA) based on liver function change as the candidate biomarker for DILI.


Eligibility criteria: Inclusion Criteria:

1. Subject with sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully informed about the study procedures
2. Healthy male of female subjects aged 20 - 45 years
3. Subjects whose body mass index (BMI) in the range 18.5 kg/m2 (inclusive) - 27 kg/m2 (exclusive)

Exclusion Criteria:

1. Subject with clinically significant disease in liver, kidney, nerve system, respiratory system, endocrine system, blood, tumor, urinary system, cardiovascular system, mental disease or with medical history
2. Subject who has taken any prescribed drugs, herbal agents or crude drugs within 2 weeks before study drug administration
3. Subject who did blood donation during 1 months before the study or Blood donation during 2 months before the study
4. Subject with presence or history of severe adverse reaction to study drug
5. Subject who cannot prevent pregnancy during the study period.
6. Female subject who are pregnant.
7. Subject who drank over 21 units/week of alcohol or subjects who would not be able to stop drinking alcohol during the hospitalization
8. Subject who are Heavy smoker more than 10 cigarettes/day within 3 months prior to screening or subjects who would not be able to stop smoking during the hospitalization.
9. Subject judged not eligible for study participation by investigator.

Primary outcomes:
measure: Aspartate Aminotransferase (AST)
timeFrame: 22 days
measure: Alanine Aminotransferase (ALT)
timeFrame: 22 days
measure: Alkaline phosphatase (ALP)
timeFrame: 22 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jieon Lee
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: In-Jin Jang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06146023: Performance of Robotic Microsurgery Systems
Official title: Preclinical Performance of The Combined Application of Two Robotic Systems in Microsurgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Robotic Surgery
Microsurgery
Anastomosis
Keywords: Learning curve
Robotics
Surgical ergonomics
Surgical training
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2023-11-24
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of conventional manual microsurgery versus robot-assisted microsurgery
Primary purpose: TREATMENT

Brief summary: The goal of this preclinical trial is to learn about the benefits and limitations of novel robotic devices for microsurgery, based on different levels of microsurgical experience. The main questions it aims to answer are:

Is robot-assisted microsurgery faster, better and more ergonomic than conventional microsurgery in a preclinical standardized setting?

Participants will perform microvascular anastomoses on 1.0-mm-diameter artificial silicone vessels using a conventional manual approach versus a novel robot-assisted approach. Researchers will compare the performance of novices, advanced participants and experts to evaluate the role of microsurgical experience when learning the new technique.

Detailed description: Recent advancements in the development of robotic devices increasingly draw the attention towards the concept of robotic microsurgery, as several systems tailored to open microsurgery are being introduced. This study describes the combined application of a novel microsurgical robot, the Symani, with a novel robotic microscope, the RoboticScope, for the performance of microvascular anastomoses in a two-center preclinical trial.

Eligibility criteria: Inclusion Criteria:

* Novices: no prior experience in microsurgery
* Residents: 2-4 years of experience in microsurgery
* Experts: at least 5 years of experience in microsurgery

Exclusion Criteria:

* previous training with the robotic devices applied in this study
* contraindications for usage of robotic devices (magnetic field)

Primary outcomes:
measure: Surgical time
timeFrame: Duration of anastomosis
measure: Anastomosis quality
timeFrame: Evaluated right after completion of each anastomosis
measure: Microsurgical skills
timeFrame: Duration of anastomosis
Secondary outcomes:
measure: Subjective Satisfaction
timeFrame: Evaluated right after completion of each anastomosis
measure: Surgical ergonomics
timeFrame: Evaluated right after completion of each anastomosis
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Münster
country: Germany
facility: University Hospital Muenster
Study officials:
affiliation: University Hospital Muenster
name: Maximilian Kückelhaus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Haripriya S Ayyala, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00700323: PS-Omega3 Supplementation to Attention Deficit Hyperactivity Disorder (ADHD) Children
Official title: Phase 2b Study of PS-Omega3 Conjugate Supplementation to ADHD Diagnosed Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: ADHD
Keywords: ADHD
ADHD diagnosed children
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Enzymotec
First posted: 2008-06-18
Enrollment: 45
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effect of phosphatidylserine-omega-3 consumption on the immune system parameters in children suffering from attention and concentration deficits.


Eligibility criteria: Inclusion Criteria:

1. Parental written informed consent.
2. Age: 13≥ years ≥8 (including).
3. Gender: both male and female.
4. TOVA computerized test score ≤-1.8 at baseline.
5. Language: Subjects, parents, and teachers must be able to read, write and speak Hebrew.
6. Normal weight and height according to Israeli standards.
7. 21 days without any treatment for ADHD symptoms, whether medication or food supplement.

Exclusion Criteria:

1. History or current diagnosis of any serious systemic (e.g., diabetes, hyper/hypothyroidism, etc.) or neurological condition (e.g., epilepsy, brain tumors, etc.)
2. Pervasive developmental disorder or Non-Verbal Learning Disability
3. Any evidence of psychotic disorders, suicidal risk, any current psychiatric co-morbidity that required psychiatric pharmacotherapy.
4. History of allergic reactions or sensitivity to marine products (seafood), soy or corn as well as any illness, which may jeopardize the participants health or limit their successful trial completion.
5. Having a sibling already included in the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Nachum Vaisman, Prof'
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05749523: The Influence of Exercise and Hydration to the Pharmacological Response to Inhaled Terbutalin and Salbutamol in Men
Official title: The Influence of Exercise and Hydration to the Pharmacological Response to Inhaled Terbutalin and Salbutamol in Men
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Healthy
Keywords: exercise
dehydration
Salbutamol
Terbutalin
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To investigate the effects of dehydration and exercise for the urine secretion of beta2-agonists.

Detailed description: No studies have examined the influence of factors such as exercise and dehydration on the pharmacokinetic profile of asthmatic drugs (beta2-agonists). Exercise may modify the metabolism and excretion of drugs, and sweat loss during exercise can result in dehydration, both affecting the urine concentration of the drug.

Eligibility criteria: Inclusion Criteria:

* men
* aerobic capacity more than 50ml / min / kg
* more than 5h training pr week

Exclusion Criteria:

* smokers
* allergy for the medicine
* chronic diseases

Primary outcomes:
measure: Urine concentration of salbutamol and terbutalin
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Respiratory Medicine, L, Bispebjerg Hospital,
state: NV
Study officials:
affiliation: Dept of Respiratory Medicine, Bispebjerg University Hospital
name: Vibeke Backer, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02907138: Medical Yoga for Patients With Stress-related Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress-related Illness/Anxiety
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2016-09-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of Medical Yoga as a group treatment, to conventional treatment provided by a physical therapist, for people with perceived stress-related symptoms.

Forty people are to be randomized to either:

1. Intervention Group - Medical Yoga, group treatment for eight weeks, 60 minutes per week, with the guidance of a physical therapist.

   or
2. Control - treatment as usual (TAU) in physical therapy.


Eligibility criteria: Inclusion Criteria:

* Perceived stress and anxiety, which could be expressed as for example as tension in the neck and shoulders, insomnia, anxiety and headaches.

Exclusion Criteria:

* Do not understand Swedish (as group instructions need to be understood),
* Pregnancy,
* Psychotic symptoms,
* Ongoing or physical therapy treatment the last three months,
* Previously participated in Medical Yoga group.

Primary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
measure: Health-related quality of Life; EQ5D
timeFrame: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
measure: Thorax excursion: Measured in centimeters with tape measure, chest size at the level of processus xiphoideus, the difference between the maximum inhalation and exhalation is registered
timeFrame: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
measure: Health-related quality of Life; EQ-VAS
timeFrame: baseline, follow-up at approx 8 weeks after first treatment session, follow-up at approx 20 weeks after first treatment session
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Narhalsan Gibraltar rehabmottagning
Study officials:
References:
Clinical trial NCT01455038: Heart Rate Variability of Patients With Bipolar Disorder in Subsyndromal Depressive Phase
Official title: Heart Rate Variability of Patients With Bipolar Disorder in Subsyndromal Depressive Phase
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Subsyndromal Depressive Phase
Heart Rate Variability
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Korean Health Technology R&D Project, Ministry of Health & Welfare
First posted: 2011-10-19
Enrollment: 92
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirty three (10 males, 23 females) patients in clinically remitted state diagnosed with bipolar disorder based on DSM-IV criteria were enrolled at one outpatient psychiatric clinic and 59 healthy controls (23 males, 36 females) from health promotion center in a university-affiliated general hospital. We defined an individual patient as being in subsyndromal depressive phase when the patient had a Montgomery-Åsberg depression rating scale (MADRS) score of 10 or less and Clinical Global Impression severity (CGI-S) of 3 or less for last one month. Healthy controls had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist.

Brief summary: The purposes of this study were: (1) to compare heart rate variability between bipolar patients in subsyndromal depressive phase and healthy controls (2) to evaluate the relation between the severity of subsyndromal depressive symptoms and reduced heart rate variability.


Eligibility criteria: Inclusion Criteria:

1. Bipolar group:

   * DSM-IV bipolar disorder
   * Montgomery-Åsberg depression rating scale (MADRS) score for last one month : ≤ 10
   * Clinical Global Impression severity (CGI-S) for last one month : ≤ 3
2. Healthy controls group: Subjects had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist.

Exclusion Criteria:

* Psychiatric disorder except bipolar disorder
* Neurological symptoms or signs
* History of head trauma
* History of cardiovascular diseases
* Any medication except psychiatric medication.

Primary outcomes:
measure: Heart rate variability (HRV)
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
Study officials:
References:
Clinical trial NCT04689438: GCF Levels of IL-1β and IL-6 in Gingivitis and Stage III-Grade C Periodontitis
Official title: Usak University Faculty of Dentistry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Keywords: periodontal disease
periodontitis
gingivitis
cytokines
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: individuals who have periodontal disease will be selected

Brief summary: Periodontal diseases are chronic diseases that occur as a result of a violation of the balance between microbial dental plaque and the host response. Gingivitis is a disease characterized by inflammation of the gingiva that occurs in one or more areas without loss of attachments.1 in periodontitis, an inflammatory event that begins in the gingiva along with gingivitis spreads to the periodontal ligament, alveolar bone and soft tissues that support the tooth, causing the destruction of these structures.2 Cytokines are low molecular weight proteins that participate in the initial and active stages of inflammation and immunity. In periodontal disease pathogenesis, cytokine response has been reported to play a very critical role in determining disease progression.3 IL-1beta and IL-6 are key cytokines in chronic inflammatory diseases and have the potential to initiate bone loss and tissue destruction seen in periodontal disease.4the purpose of this study; it is to determine the degree of inflammation and periodontal destruction by determining the levels of IL-1beta and IL-6 cytokines in the gingival crevicular fluid of periodontal healthy and diseased individuals.

Detailed description: Periodontal measurement were done at 6 sites per tooth After clinical evaluation, individuals were divided into 3 groups

1. Healthy control groups:

   clinically healthy gingiva
2. Gingivitis groups:

   BOP score of 10% or greater and PD≤3mm
3. Periodontitis groups:

AL ≥5 mm, PD≥6 mm and tooth loss due to periodontitis of ≤4. GCF samples were collected using strips.

Eligibility criteria: Inclusion Criteria:

* have periodontitis
* have 16 permanent teeth

Exclusion Criteria:

* Systemic disease
* using drugs

Primary outcomes:
measure: Measurement of IL-1Beta level
timeFrame: GCF was taken within 1 week after clinical examination
measure: Measurement of IL-6 level in GCF
timeFrame: GCF was taken within 1 week after clinical examination
Secondary outcomes:
Other outcomes:
Locations:
city: Uşak
country: Turkey
facility: University of Usak
Study officials:
affiliation: University of Usak
name: ahu dikilitaş
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Usak
name: fatih karaaslan
role: STUDY_CHAIR
affiliation: University of IZMIR KATİP CELEBİ
name: abdullah seçkin ertuğrul
role: STUDY_CHAIR
References:
Clinical trial NCT04208438: Non-Invasive Jugular Venous Blood Volume Assessment (BVI)
Official title: Non-Invasive Jugular Venous Blood Volume Assessment (BVI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasound Evaluation
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: Mespere Lifesciences Inc.
First posted: 2019-12-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: The purpose of this study is to evaluate the ability of the Mespere Blood Volume Index (BVI) device to calculate the blood volume in the jugular veins by comparing the measurements from the device to volumetric measurements obtained with ultrasound.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or greater
2. English-speaking
3. No known medical conditions requiring treatment by a physician

Exclusion Criteria:

1. Substantial amount of neck hair preventing adhesion of the neck patch of the BVI
2. History of congenital heart disease
3. History of thoracic, neck or brain surgery
4. Inability to lay supine at 30 degrees incline or 60 degrees incline for the duration of the study measurements
5. Pregnancy

Primary outcomes:
measure: Comparison of jugular vein blood volume
timeFrame: One Hour
Secondary outcomes:
measure: Comparison of changes in measurement of jugular venous blood volume
timeFrame: One Hour
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Integrative Biosciences Center - Clinical Research Service Center
state: Michigan
Study officials:
References: