louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02528578: Modulation of Painful Perception
Official title: Modulation of Painful Perception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: healthy volunteers
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of the study is to evaluate in healthy volunteers, the influence of empathy on pain perception.

It is widely accepted in the clinical management that the feeling of listening to the patients' pain would have a favorable influence on the pain, and conversely, the lack of listening would be aggravating.

In this study, the volunteer will receive painful thermal stimuli in empathetic context (l, empathetic or non-empathetic) Two situations will oppose, one where the examiner neglect or minimize the suffering of the voluntary and the other or the contrary, the subject will receive empathy.

The first part of the project is to verify that the pain is influenced by the empathetic context. The second part will be conducted functional MRI, which should isolate the brain regions affected by other people's empathy for pain.


Eligibility criteria: Inclusion Criteria:

* Right handed

Exclusion Criteria:

* Pregnant or lactating women,
* Against-indications to MRI
* Drug intake of less than 12 hours,
* Neurological history or deficits, psychiatric, auditory or visual.
* Decline to participate

Primary outcomes:
measure: Intensity of the perceived pain assessed by the volunteer by a analog scale (VAS) at each thermal stimulation.
timeFrame: Day 0
Secondary outcomes:
measure: blood-oxygen-level dependent (MRI)
timeFrame: Day 0
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de LYON
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Roland PEYRON, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05677178: Response Prediction in EBV-HLH Using Metabonomics Analysis
Official title: Response Prediction in EBV-HLH Using Metabonomics Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemophagocytic Lymphohistiocytoses
EBV
Metabonomics
Keywords: Hemophagocytic Lymphohistiocytoses
EBV
matabonomics
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were diagnosed with EBV-HLH in China.

Brief summary: Hemophagocytic lymphohistiocytosis (HLH) is a rare, poorly recognized and underdiagnosed syndrome of excessive immune activation, which is rapidly fatal. Epstein-Barr virus (EBV) is a common trigger of HLH, particularly in Asian individuals. We aim to analyze metabolomics and cytokine profiles of patients before and after treatment to explore the metabolomic characteristics of EBV-HLH, and search for pathogenic mechanisms and therapeutic targets.

Detailed description: Hemophagocytic lymphohistiocytosis (HLH) is a rare, poorly recognized and underdiagnosed syndrome of excessive immune activation, which is rapidly fatal. Without early intervention, the median survival time is less than 2 months.Epstein-Barr virus (EBV) is a common trigger of HLH, particularly in Asian individuals. We aim to analyze metabolomics and cytokine profiles of patients before and after treatment to explore the metabolomic characteristics of EBV-HLH, and search for pathogenic mechanisms and therapeutic targets.

Eligibility criteria: Inclusion Criteria:

* Patients who meet HLH-04 diagnostic criteria
* EBV-DNA viral load in the peripheral blood \> 500 copies/mL
* Informed consent obtained.

Exclusion Criteria:

* refuse to participate.

Primary outcomes:
measure: Difference in metabonomics pattern between subgroups
timeFrame: 2 months
measure: Difference in cytokine pattern between subgroups
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Zhao Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02503878: Sedline 4 Channel Electroencephalogram (EEG) Monitoring During Suppression of Unilateral Hemispheric Function (Wada Test
Official title: Sedline 4 Channel Electroencephalogram (EEG) Monitoring During Suppression of Unilateral Hemispheric Function (Wada Test)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Seizure
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2015-07-21
Enrollment: 7
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: Participants will be 10 adult patients over 18 years old scheduled for Wada Testing at MUSC. One of the study team members will inform patients scheduled to undergo surgery about the opportunity to participate in the study prior to surgery. Patients will review and sign a written informed consent with a research study team member.

Brief summary: Masimo Sedline brain function monitors are sensors (stickers) placed on a the forehead to monitor levels of "sedation" based on a bilateral 4-channel electroencephalogram (EEG). The purpose of this study is to observe the effectiveness of the Sedline monitor to detect the unilateral hemispheric EEG changes seen in Wada testing


Eligibility criteria: Inclusion Criteria:

18 years of age or older

scheduled for Wada testing at MUSC

Exclusion Criteria:

No exclusions

Primary outcomes:
measure: Masimo Sedline brain function monitor- based on a bilateral 4-channel electroencephalogram (EEG). The purpose of this study is to observe the effectiveness of the Sedline monitor to detect the unilateral hemispheric EEG changes seen in Wada testing
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT03660878: A Methodology Development Environmental Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis
Official title: A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Methodology Development Environmental Clinical Trial With Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects With Seasonal Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Allergic Conjunctivitis
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-07
Enrollment: 52
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: A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Methodology Development Environmental Clinical Trial with Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects with Seasonal Allergic Conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* be at least 18 years of age of either gender and any race
* have a positive history of ocular allergies and a positive skin test reaction to ragweed pollen as confirmed by the allergic skin test given to the subject within 24 months of the subject's Visit 1
* have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart

Exclusion Criteria:

* have known contraindications or sensitivities to the use of any of the investigational product medication or components
* have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium, or a diagnosis of dry eye)
* have had ocular surgical intervention within three months prior to Visit 1, or during the trial, or a history of refractive surgery six months prior to Visit 1, or have systemic surgery planned during the clinical trial or within 30 days after;
* have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
* have an active ocular infection (bacterial, viral or fungal), active uveitis, or positive history of an ocular herpetic infection at any visit;
* be a female who is currently pregnant, planning a pregnancy, or lactating

Primary outcomes:
measure: Change From Baseline Ocular Itching Score on High Pollen Days
timeFrame: Efficacy was assessed on high-pollen days over 28 days of treatment; baseline was assessed approximately one week before dosing.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Slade & Baker Vision
state: Texas
Study officials:
References:
citation: Cavanagh B, Gomes PJ, Starr CE, Nichols KK, Brady TC. Reproxalap Activity and Estimation of Clinically Relevant Thresholds for Ocular Itching and Redness in a Randomized Allergic Conjunctivitis Field Trial. Ophthalmol Ther. 2022 Aug;11(4):1449-1461. doi: 10.1007/s40123-022-00520-z. Epub 2022 May 18.
Clinical trial NCT01615978: Safety and Tolerability of Liraglutide in Japanese Subjects With Type 2 Diabetes
Official title: A Randomised, Double-blind Within Dose Group, Single-centre, Placebo-controlled, Parallel 2-different Dose Group, 14-day Multiple s.c. Doses Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Liraglutide (NNC 90-1170) in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-06-11
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. The aim of this trial is to assess the safety after multiple s.c. (subcutaneously) doses of liraglutide in Japanese subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Duration of diabetes for more than 12 weeks
* Subjects currently on diet therapy (OHA-naïve) or treated with OHA (oral hypoglycaemic agent)
* monotherapy for more than 12 weeks
* HbA1c (Glycated haemoglobin A1c) between 6.0-9.0 %, both inclusive
* Body Mass Index (BMI): 18.5-30.0 kg/m\^2

Exclusion Criteria:

* Recurrent severe hypoglycaemia
* Proliferative retinopathy or maculopathy requiring acute treatment
* Impaired hepatic function
* Impaired renal function
* Cardiac problems
* Uncontrolled treated/untreated hypertension
* Current treatment with insulin preparations or TZDs (thiazolidinediones)
* Current treatment or expected at the screening to start treatment with systemic corticosteroids

Primary outcomes:
measure: 24-hour profiles of serum calcitonin
measure: 24-hour profiles of Ca2+ (ionised calcium)
measure: 24-hour profiles of PTH (Parathyroid Hormone)
measure: Adverse events
Secondary outcomes:
measure: Area under the plasma liraglutide curve
measure: Cmax, maximum plasma liraglutide concentration
measure: tmax, time to reach Cmax
measure: Terminal phase elimination rate-constant
measure: t½, terminal elimination half life
measure: 24-hour profiles of serum insulin
measure: 24-hour profiles of plasma glucose
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Kageyama S, Hirao K, Shimizu A, Matsumura Y, Zdravkovic M, Rasmussen MF, Irie S. Tolerability, pharmacokinetics, and pharmacodynamics of liraglutide, long-acting human GLP-1 analogue - Phase 1 studies in Japanese healthy subjects with type 2 diabetes. Endocrinology and Diabetology 2007; 24 (6): 95-104
Clinical trial NCT03025178: Optimal Insertion Depth of Left Internal Jugular Vein Catheter in Infants
Official title: External Validation of Predictive Formula for Optimal Insertion Depth of Left Internal Jugular Venous Catheter in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Venous Catheter
Infant
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-01-19
Enrollment: 46
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: We previously performed a study to create formula for the optimal insertion depth of left internal jugular vein catheter in infant, which was registered at cris.nih.go.kr. We found that two calculation methods using height and the distance between landmarks (0.11 × height (cm) + 0.19 and 1.02 × I-A-B (cm) + 1.55, where I was insertion point of needle, A was the most prominent point of the sternal head of the left clavicle, and B was the midpoint of the perpendicular line drawn between the sternal head of the right clavicle and an imaginary line between the nipples) were clinically feasible to determine the insertion depth of left internal jugular vein catheter. In this study, we will compare the actual insertion depth with the insertion depth determined from above two calculation methods in other 46 infants.

Detailed description: determine the optimal insertion depth of left internal jugular vein catheter in infants

Eligibility criteria: Inclusion Criteria:

* An infant requiring a central venous catheter during surgery

Exclusion Criteria:

* Extracardiac vascular anomaly
* Dextrocardia
* Anatomical abnormality in neck and thorax

Primary outcomes:
measure: The actual insertion depth of central venous catheter
timeFrame: About 5 minutes during central venous catheterization (10 minutes after anesthetic induction)
Secondary outcomes:
measure: The differences between the actual insertion depth and the predicted insertion depth derived from two calculation methods
timeFrame: About 5 minutes during central venous catheterization (10 minutes after anesthetic induction)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUH
state: Jongro Gu
Study officials:
affiliation: Seoul National University Hospital
name: Hee-Soo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04092478: '' Abdominal Crunch Positions With the Others in Terms of Interspinous Distance in Adult Patients ''
Official title: ''Compare Abdominal Crunch Positions With Conventional Sitting and Lateral Decubitus Positions in Terms of Interspinous Distance in Adult Patients''
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Spinal
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: One hundred of patients over the age of 18 who will undergo elective surgery will be included in the study.

Brief summary: The most important factor for ease of operation and safety during spinal anesthesia is the determination of the spinal space. Increasing lumbar flexion facilitates access to the spinal space. Traditionally, patients undergo spinal anesthesia with lateral or sitting lumbar flexion.

In a study by Martha L Walker et al., The maximum extension of the knees, adduction of the hip, and a modified sitting position with the back flexion, ie, the abdominal crunch position, were found to be effective in increasing the flexion of the lumbar spine.

In our study, we aimed to measure the interspinal distance with the abdominal crunch position with the help of ultrasonography (USG) and to compare the interspinal distance with the measurements obtained in traditional positions (sitting position and lateral decubitus).

Detailed description: Interspinal distance will be measured by ultrasonography by 3 different positions, respectively, for the patients who will undergo elective surgery and meet the study criteria and give voluntary consent.

This evaluation process is to record and compare the measurement results. Patients will not undergo any interventional procedures.

Patients who have difficulty in positioning due to hip, femur, knee and tibial fractures or arthrosis and who cannot be communicated will not be included in the study.

One hundred of patients over the age of 18 who will undergo elective surgery will be included in the study.

Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18
* Undergo elective surgery

Exclusion Criteria:

* Patients with vertebral anomaly
* Patient with not communicated

Primary outcomes:
measure: Inter spinal distance
timeFrame: Through study completion, an average of 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Yasin Tire
state: Meram
Study officials:
affiliation: Konya Meram State Hospital
name: Yasin Tire, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06346678: Accuracy of Accuhaler Tester, Ellipta Tester and Turbutester in Patients with Chronic Obstructive Pulmonary Disease
Official title: Accuracy of Accuhaler Tester, Ellipta Tester and Turbutester in Patients with Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease
COPD
Accuhaler tester
Ellipta tester
Turbutester
Peak inspiratory flow rate
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 82
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients aged 40 years or older who are confirmed diagnosis by spirometry (post-bronchodilator FEV1/FVC \<0.7) and smoking history 10 pack-years or more.

Brief summary: The goal of this observational study is to investigate the accuracy of Accuhaler tester, Ellipta tester and Turbutester in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:

• Do Accuhaler tester, Ellipta tester, and Turbutester demonstrate comparable accuracy to the In-check DIAL for assessing inspiratory inhalation force in COPD patients?

Detailed description: This study is a cross-sectional study. COPD patients aged 40 years or older will be included. Peak inspiratory flow rate (PIFR) will be assessed using In-check DIAL as the standard tool. PIFR will be tested in each patient using Accuhaler tester, Ellipta tester and Turbutester.

Eligibility criteria: Inclusion Criteria:

* COPD diagnosis with confirmed by post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) \<0.7
* Age 40 years or older
* Smoking history 10 pack-years or more

Exclusion Criteria:

* COPD exacerbation within 3 months
* Oral or intravenous corticosteroid treatment within 6 weeks
* Inability to perform assessment of peak inspiratory flow rate
* Asthma
* Tracheostomy, invasive or noninvasive mechanical ventilation

Primary outcomes:
measure: Accuracy of Accuhaler tester
timeFrame: At day 1 of the study
measure: Accuracy of Ellipta tester
timeFrame: At day 1 of the study
measure: Accuracy of Turbutester
timeFrame: At day 1 of the study
Secondary outcomes:
measure: Prevalence of suboptimal peak inspiratory flow rate
timeFrame: At day 1 of the study
measure: Prevalence of insufficient peak inspiratory flow rate
timeFrame: At day 1 of the study
Other outcomes:
Locations:
city: Klongluang
country: Thailand
facility: Narongkorn Saiphoklang
state: Pathumthani
Study officials:
affiliation: Thammasat University Faculty of Medicine
name: Narongkorn Saiphoklang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01743378: Ultrasound Guided Transversus Abdominis Plane Block With Ropivacaine vs Placebo for Abdominal Hysterectomy: a Double-blinded, Randomized Clinical Trial
Official title: Ultrasound Guided Transversus Abdominis Plane Block With Ropivacaine vs Placebo for Abdominal Hysterectomy: a Double-blinded, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain and Postoperative Morphine Consumption After Abdominal Hysterectomy
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Prospective double-blinded randomized clinical trial to test the effect of transversus abdominis plane block on postoperative pain and opoid consumption after abdominal hysterectomy.

Two groups of each 24 patients. All patients are given general anesthesia. The patients are randomized to have a ultrasound guided bilateral transversus abdominis plane block with either 2 x 20 ml 0,75 % ropivacaine or 2 x 20 ml of 0,9 saline. All patients are provided with a PCA for self administration of morphine.

Pain score on visual analog scale, nausea and vomiting are monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively as well as the total consumption of morphine after 24 hours.


Eligibility criteria: Inclusion Criteria:

* Assigned to elective abdominal hysterectomy
* Must be able to understand and speak danish
* Must be able to give verbal and written consent

Exclusion Criteria:

* Abuse of alcohol or medicin
* Daily treatment with opoids or glucocorticoids
* Allergy towards any kind of localanesthetic drug
* Intolerance toward morphine
* Psychiatric desease
* Age below 18

Primary outcomes:
measure: Total morphine consumption during first 24 hours postoperatively
timeFrame: At 24 hours postoperatively
Secondary outcomes:
measure: Postoperative pain by visual analog scale at
timeFrame: Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively
Other outcomes:
measure: Postoperative nausea and vomiting
timeFrame: Monitored at 1, 2, 4, 6, 8 and 24 hours postoperatively
measure: Length of stay
timeFrame: First 72 hours after surgery
measure: Time until mobilization
timeFrame: First 24 hours postoperatively
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
state: Hovedstaden
Study officials:
References: