louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04209517: Behavioral Markers of Pre-operative Anxiety
Official title: Behavioral Markers of Pre-operative Anxiety : a Prospective Observational Study in Ambulatory Setting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Preoperative Anxiety
Keywords: Preoperative anxiety
ethology
behavioural markers
objective detection
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 120
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: Adult patients scheduled for elective ambulatory surgery

Brief summary: The purpose of this study is to identify the characteristics of patients' behavioural patterns related to declared anxiety levels in a day-care surgical unit using ethological analysis of video-recordings of the pre-operative interview with the nurse.

Detailed description: Guidelines in anaesthesia recommend systematic preoperative anxiety management to prevent negative perioperative impact, including impaired memory of important instructions and high incidence of post-operative acute and chronic pain. Self-administered questionnaires linked to scales to assess anxiety in the preoperative setting are usual practice. Yet, they are time consuming and rely on patient willingness to comply with instructions, which is not always reliable. The effects of acute anxiety on behaviour are poorly explored in the preoperative context. Quantifying and characterizing behavioural patterns in anxious patients using an applied ethological approach may provide useful information for reliable, accurate and objective assessment before surgery.

Eligibility criteria: Inclusion Criteria:

* adult patients scheduled for elective ambulatory surgery

Exclusion Criteria:

* communication difficulties

Primary outcomes:
measure: Correlation between behaviour and anxiety
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05447117: Subthreshold Micropulse Laser Treatment of Acute Central Serous Chorioretinopathy
Official title: Subthreshold Micropulse 532 nm Green Laser Treatment of Acute Central Serous Chorioretinopathy: 18-month Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Central Serous Retinopathy With Subretinal Fluid
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of 532 nm green subthreshold micropulse laser (GSML) as a treatment for acute central serous chorioretinopathy (CSCR).

Detailed description: This prospective study included 42 eyes of 42 patients with acute CSCR treated with IRIDEX™ IQ 532 nm GSML. The study was conducted at Minia University Hospital and Genaidy Ophthalmology Center, Minia, Egypt between October 2019 and May 2022. All patients were subjected to a complete ophthalmological examination, fluorescein angiography (FA) and optical coherence tomography (OCT) at baseline and each follow-up visit 1, 3 and 18 months after laser treatment

Eligibility criteria: Inclusion Criteria:

* acute CSCR

Exclusion Criteria:

* chronic CSCR Previously treated case of Acute CSCR

Primary outcomes:
measure: change in visual acuity
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia University Hospital
state: Minia
Study officials:
References:
Clinical trial NCT03267017: Correlation Between Respiratory Variability of R-R Intervals and Systolic Pressure Variability
Official title: Correlation Between Respiratory Variability of R-R Intervals and in Invasive Systolic Blood Pressure During Changes in Posture and Positive End Expiratory Pressure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Rate Determination
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study patients

Brief summary: This prospective study is designed to assess and quantify the correlation between respiratory changes in R-R interval and the respiratory changed in invasive systolic blood pressure in ventilated patients during changes in posture and peak end expiratory pressure (PEEP) and following a fluid bolus


Eligibility criteria: Inclusion Criteria:

* Age 18-80
* Scheduled for surgery under general anesthesia requiring invasive blood pressure monitoring

Exclusion Criteria:

* Heart Rate other than sinus
* Cardiac Pacemaker Status
* Transplanted Heart

Primary outcomes:
measure: Statistical Correlation between respiratory variability of R-R interval and systolic blood pressure
timeFrame: From immediately after induction of general anesthesia and mechanical ventilation to 20 minutes later
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04474717: Chronic Obstructive Pulmonary Disease in Combination With Atherosclerosis (Clinical and Biochemical Study)
Official title: Clinical and Biochemical Assessment of the Course of Chronic Obstructive Pulmonary Disease in Combination With Atherosclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Peripheral Artery Disease
Keywords: COPD
peripheral atherosclerosis
comorbidity
Lead sponsor: Ryazan State Medical University
Sponsor class: OTHER
First posted: 2020-07-17
Enrollment: 476
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: one-centered, open, non-randomized, controlled clinical trial will focus on a comprehensive study of the clinical, functional and molecular biochemical characteristics of the natural course of COPD in combination with peripheral atherosclerosis

Detailed description: Risk factors, chronic respiratory symptoms and respiratory function in the natural history of COPD will be monitored. In a group of patients with a comorbid course of COPD and atherosclerosis, systemic inflammation and its molecular mechanisms will be investigated. Also in this group, the role of non-coding miRNAs will be analyzed. The study also includes an analysis of the clinical and biochemical COPD phenotype with systemic inflammation and comorbidity.

Eligibility criteria: Inclusion Criteria:

1. A significant diagnosis of COPD, confirmed by spirometry criteria, typical clinical presentation.
2. A significant diagnosis of peripheral atherosclerosis
3. The high level of adherence to treatment
4. Signed informed agreement

Exclusion Criteria:

1. The presence of other chronic respiratory diseases in the patient, including bronchial asthma
2. Known oncological diseases of any localization
3. HIV infection and other immunodeficiency conditions
4. Inability to understand and comply with the requirements of the research protocol.

Primary outcomes:
measure: mortality
timeFrame: 12 months
measure: lung function
timeFrame: 12 months
measure: exacerbations
timeFrame: 12 months
measure: markers of inflammation
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical University
state: Please Select
Study officials:
References:
Clinical trial NCT04537117: Knowledge, Attitudes and Clinical Practices of Pediatric Dentists Regarding Covid-19
Official title: Knowledge, Attitudes and Clinical Practices of Pediatric Dentists Regarding Covid-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
Pediatric Dentists
Attitudes
Clinical Practices
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 202
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric dentists, practicing during the COVID-19 pandemic

Brief summary: This study aims to assess the level of knowledge, attitudes and clinical practices of pediatric dentists regarding COVID-19 pandemic outbreak and evaluate the psychological burden on the dentists and children

Detailed description: Aim: This cross sectional study aims to assess the level of knowledge, attitudes and clinical practices of pediatric dentists regarding COVID-19 pandemic outbreak and evaluate the psychological burden on the dentists and children.

The study population is pediatric dentists recruited through five pediatric dentists Facebook groups. Web-based questionnaire was created using Google forms, structured of multiple-choice questionnaire, and divided into: (demographic, knowledge, practices, and behavior management techniques) sections. Descriptive statistical analysis was used to describe items included in the survey. Numbers and percentages were used to describe categorical data.

Eligibility criteria: Inclusion Criteria:

Practicing pediatric dentists working in private practices or institutions

Exclusion Criteria Dentists specialized in other disciplins

Primary outcomes:
measure: Responses
timeFrame: 0 days
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University
Study officials:
affiliation: Fayoum University
name: Maha M Azab, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03077217: Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy
Official title: Low-dose Rifaximin in the Treatment of Covert Hepatic Encephalopathy: A Randomized Open Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Covert Hepatic Encephalopathy
Keywords: covert hepatic encephalopathy
low-dose rifaximin
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several studies have been showed that rifaximin can improve cognitive functions, driving simulator performance and health-related quality of life in patients with minimal hepatic encephalopathy. The aim of this prospective randomized open controlled study was to evaluate the efficacy and safety of rifaximin at different doses for the treatment of covert hepatic encephalopathy.


Eligibility criteria: Inclusion Criteria:

1. Patients agreed to sign the informed consents
2. Patients aged 18-70 years，males or females
3. Patients who were diagnosed with occult hepatic encephalopathy by PHES and Stroop tests

Exclusion Criteria:

1. Allergy to rifamycin/rifamutin/rifampin/rifapentine
2. Current or recent (\<3 month) use of alcohol or can't stop drinking during the study period
3. Use of antibiotics within last 6 weeks
4. Use of lactulose/lactitol, probiotics, L-ornithine-L-aspart，zinc，metronidazole, neomycin, or rifaximin within last 6 weeks
5. Infection or gastrointestinal hemorrhage within last 6 weeks
6. Use of psychoactive drugs within last 6 weeks
7. Occurred overt hepatic encephalopathy within last 3 months
8. history of portosystemic shunt surgery or transjugular intrahepatic portosystemic shunt
9. Poor vision, color blindness or motor defects that interfere with the performance of psychometric tests
10. Other non-controllable neurological or psychiatric problems which may affect cognitive function such as Alzheimer's disease, Parkinson's disease or schizophrenia
11. Conformed or highly suspicious diagnosis of liver malignant tumors
12. Human immunodeficiency virus (HIV) infection
13. Uncontrolled hypertension, diabetes or other serious cardiac and pulmonary diseases
14. White blood cell count\<1×10\^9/L
15. Pregnancy and breastfeeding
16. Participated in other drug clinical trials within 3 months
17. The researchers thought it was not suitable for this clinical trial

Primary outcomes:
measure: Percentage of patients showing covert hepatic encephalopathy reversal
timeFrame: up to 6 months
measure: health-related quality of life improvement
timeFrame: up to 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai changzheng Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT00737217: Executive, Activities of Daily Living, and Cholinergic Functions in Parkinson's Disease
Official title: Executive, Activities of Daily Living, and Cholinergic Functions in Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2008-08-18
Enrollment: 74
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease, either with or without memory or concentration difficulties, and normal control persons between the ages of 50-85 years are eligible to participate in this study. Participants should be willing and able to comply with study requirements. Normal control persons should not have a history of brain or mental disorders. Both males and females are eligible.

Brief summary: This research study will evaluate functions of memory, thinking, behavior, and daily life activities and how these relate to the measurement of certain chemicals (acetylcholine and dopamine) in the brain using an imaging procedure called positron emission tomography (PET). You may know that in Alzheimer's dementia (dementia is a disease where persons become forgetful and confused), a reduction in the amount of acetylcholine, a "neurotransmitter" substance (a chemical messenger that nerve cells need to communicate with each other), may be responsible for some of the memory and behavioral changes. At the present time, the investigators have no clear information on the levels of acetylcholine in the brain of patients with Parkinson's disease who also have memory or behavioral changes.


Eligibility criteria: Inclusion Criteria:

* PDD: Patients who meet the UK Parkinson's Disease Society Brain Bank Research Center (UKPDSBRC) clinical diagnostic criteria for PD with dementia (MMSE 18-25; n=28; age 50-85 years; M/F) are eligible for the study. Hoehn and Yahr stages I-III.
* PD. Patients with who meet the UKPDSBRC criteria for PD with a MMSE of \>25 (n=28; age 50-85 years; M/F). Hoehn and Yahr stages I-III.
* Normal control subjects (n=16) (age 50-85 years; M/F).
* No current or past history of neurologic or psychiatric illness.

Exclusion Criteria:

* Any subjects on cholinergic, anti-cholinergic drugs will be excluded from the study.
* Current or past history of neurologic or psychiatric illness.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Functional, Cognitive and Mobility Laboratory
state: Michigan
Study officials:
References:
Clinical trial NCT04268017: Validation Study : FeetMe® Monitor Insoles for the Evaluation of Gait Speed
Official title: Reliability and Competing Validity of the FeetMe Monitordevice® Measurement of the Spatial-temporal Parameters of the gaitRite System® in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Gait analysis
FeetMe®
GaitRite®
Healthy
Validation
Lead sponsor: FeetMe
Sponsor class: INDUSTRY
First posted: 2020-02-13
Enrollment: 30
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to validate a smart insoles system in comparison to the gold-standard GaitRite in a healthy population. The device evaluate gait parameters in real time thanks to an embedded algorithm based on the processing of inertial measurement unit and 19 sensors signals.

At D0 and D7, the volunteer is evaluated by both the GaitRite® system and the FeetMe Monitor® system simultaneously. Healthy volunteers have two measurements 7 days apart. The volunteer repeats 5 trials at a comfortable speed on the GaitRite® mat while wearing the FeetMe® insoles. Each measurement is repeated by 4 different operators. A total of 20 trials are made by the volunteer.


Eligibility criteria: Inclusion Criteria:

* Have more than 18 years old
* Don't be pregnant or breast feeding

Exclusion Criteria:

* Be part of another study
* Not be able to give consent
* Not have access to social security

Primary outcomes:
measure: Velocity measured through FeetMe Monitor device and GaitRit
timeFrame: 1 day
Secondary outcomes:
measure: Stride length measured through FeetMe Monitor device and GaitRite
timeFrame: 1 day
measure: Cadence measured through FeetMe Monitor device and GaitRite
timeFrame: 1 day
measure: Stance phase measured through FeetMe Monitor device and GaitRite
timeFrame: 1 day
measure: Swing phase measured through FeetMe Monitor device and GaitRite
timeFrame: 1 day
measure: Stride duration measured through FeetMe Monitor device and GaitRite
timeFrame: 1 day
Other outcomes:
Locations:
city: Créteil
country: France
facility: Fédération de Rééducation Neurolocomotrice, Laboratoire ARM - Hôpital Henri MONDOR, Assistance Publique - Hôpitaux de Paris
Study officials:
References:
Clinical trial NCT04190017: Comparison of Brain Volumes Measured by 2D USG and MRI
Official title: Comparison of Brain Volumes of Preterm Infants Measured by Two Dimensional Ultrasonography and Cranial Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Central Nervous System Vulnerabilities in Preterm Infants
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2019-12-09
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm infants under 32 weeks of GA and 800-1200 gram BW all admitted to Ankara Şehir Hospital MH5 NICU

Brief summary: Cranial USG is simple and easy method to assess preterm infant brain. Some studies showed that brain volumes of preterm infants could be calculated by measurement of 2D distances. Our aim in this study was to compare brain volume obtained by USG and MRI.

Detailed description: All preterm infants less than 32 weeks of gestational age undergo cranial USG examination routinely at least, in the first week of life, at the end of first month and corrected age 36 weeks and 40 weeks. We will performa all USG mesurements with measureing intracranial hegiht, anteroposterior diameter, biparietal diamater, ventriccular height, thalamo-occipital distance and ventricular index. We will calculate the brain volume as a spheric geometric shape than we will calculate two ventricles as conical shapes. Absolute brain volume will be calculating by substracting two ventricles from total brain volume. At 40 weeks of age we will perform a cranial MRI to show exact brain volume and we will ccompare two different methods.

Eligibility criteria: Inclusion Criteria:

* All preterm infants under 32 weeks of gestational age and birth weight between 800-1200 grams
* Born in our hospital
* Alive during discharge

Exclusion Criteria:

* congenital anomalies
* cranial bleeding
* early death

Primary outcomes:
measure: Results of two different brain volumes
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Mustafa Şenol Akın, MD
role: STUDY_CHAIR
References:
citation: Benavente-Fernandez I, Lubian-Gutierrez M, Jimenez-Gomez G, Lechuga-Sancho AM, Lubian-Lopez SP; Neonatal Neurology Foundation (Fundacion Nene). Ultrasound lineal measurements predict ventricular volume in posthaemorrhagic ventricular dilatation in preterm infants. Acta Paediatr. 2017 Feb;106(2):211-217. doi: 10.1111/apa.13645. Epub 2016 Nov 21.
citation: Cheong JL, Thompson DK, Spittle AJ, Potter CR, Walsh JM, Burnett AC, Lee KJ, Chen J, Beare R, Matthews LG, Hunt RW, Anderson PJ, Doyle LW. Brain Volumes at Term-Equivalent Age Are Associated with 2-Year Neurodevelopment in Moderate and Late Preterm Children. J Pediatr. 2016 Jul;174:91-97.e1. doi: 10.1016/j.jpeds.2016.04.002. Epub 2016 May 9.
Clinical trial NCT02412917: A Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia and Treatment of Acute Herpes Zoster Associated Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Shingles
Herpes Zoster
Postherpetic Neuralgia
Lead sponsor: ContraVir
Sponsor class: UNKNOWN
First posted: 2015-04-09
Enrollment: 237
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a multicenter, randomized, double-blind, parallel-group, active controlled comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes zoster).

Detailed description: This is a multicenter, randomized, double-blind, parallel-group, active controlled comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes zoster). Subjects diagnosed with uncomplicated AHZ within 72 hours of lesion appearance and worst pain of 4 or greater at day 1, will be randomized (1:1:1) to one of three treatment groups and will begin study treatment at the Day 1 visit(within 72 hours of AHZ lesion appearance) to either: 1. FV-100 400mg QD, 2. FV-100 400mg BID(total daily dose of 800mg), or 3. Valacyclovir 1000mg 3 times a day for a total daily dose of 3000mg. Subjects will be monitored for adverse events through day 21. Efficacy assessments for lesion status and AHZ pain are captured til day 120.

Eligibility criteria: Inclusion Criteria:

* Receive a clinical diagnosis of uncomplicated AHZ as evidenced by a unilateral dermatomal rash
* Have zoster-related pain
* Are able to be randomized and receive their first dose within approximately 120 hours from appearance of rash

Exclusion Criteria:

* Have multidermal or disseminated AHZ
* Have facial, ophthalmologic or oral manifestations
* Have received Zostavax

Primary outcomes:
measure: The incidence of post-herpetic neuralgia(PHN) following treatment with 2 dose regimens of FV-100 compared to valacyclovir.
timeFrame: Day 1 to Day 120
Secondary outcomes:
measure: Acute herpes zoster associated pain, as measured by Zoster Brief Pain Inventory(ZBPI)
timeFrame: Day 1 to Day 120
measure: The effect on lesion formation and healing of 2 dose regimens of FV-100 compared to valacyclovir
timeFrame: Day 1 to Day 120
measure: The number and classification of adverse events in 2 dosing regimens of FV-100
timeFrame: Day 1 to Day 120
measure: The pharmacokinetic profile of the active metabolite of FV-100 after 7 days of dosing at 400mg QD versus compared with 400mg BID
timeFrame: Day 1 to Day 120
Other outcomes:
Locations:
city: Webster
country: United States
facility: TX
state: Texas
Study officials:
affiliation: CMO
name: John Sullivan-Bolyai
role: STUDY_DIRECTOR
References: