louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06098092: Experimental Validation of the Long-term Accuracy of Blood Pressure Measurement Using a Smartwatch
Official title: Experimental Validation of the Long-term Accuracy of Blood Pressure Measurement Using a Smartwatch
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hypertension
Blood Pressure
Keywords: Smartwatch
Blood pressure
Heart rate
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional prospective single-arm study
Primary purpose: OTHER

Brief summary: The aim of the study is to perform an experimental validation of the long-term accuracy of blood pressure measurement using the Samsung Galaxy Smartwatch

Detailed description: Blood pressure is one of the basic vital signs monitored and is one of the most important indicators of a patient's health status. Cardiovascular disease is one of the leading causes of death worldwide. One of the major risk factors for cardiovascular disease is hypertension, which is globally attributed to one third of deaths in the world population. To improve the prevention of hypertension, self-monitoring of blood pressure is increasingly recommended. This project involves an experimental validation of the long-term accuracy of blood pressure measurement using the Samsung Galaxy Smartwatch compared to a medical grade digital tonometer with a cuff placed on the arm.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteer

Exclusion Criteria:

* post-traumatic conditions of the upper limbs
* tattoos, birthmarks, injuries or diseases of the skin on the wrists of hands
* cardiac arrhythmias
* circulatory or peripheral varcular disease
* aortic valve disease
* myocardiopathy
* other cardiovascular diseases
* pregnancy
* kidney disease
* diabetes
* neurotic disorder
* haemostatic disorders
* use of blood-thinning drugs

Primary outcomes:
measure: Blood pressure agreement between smartwatch and digital tonometer
timeFrame: 20-40 days
Secondary outcomes:
measure: Heart rate agreement between smartwatch and digital tonometer
timeFrame: 20-40 days
Other outcomes:
Locations:
city: Kladno
country: Czechia
facility: Czech Technical University in Prague
Study officials:
affiliation: Czech Technical University
name: Jakub Rafl
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01726192: Comparison of Two Techniques for Placement of Perineural Femoral Catheters.
Official title: Comparison of Ultrasound Hydrolocalization Technique Versus Neurostimulation for Placement of Continuous Femoral Catheters.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Anterior Cruciate Ligament Reconstruction
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2012-11-14
Enrollment: 50
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: The purpose of this study is to assess the efficacy of the hydrolocalization technique for placement of femoral perineural catheters in comparison with stimulating catheters. A non inferiority trial.

Detailed description: The investigators will randomize patients that will undergo anterior cruciate ligament reconstruction.

Each patient will receive a subgluteal single shot nerve block and a continuous femoral nerve block with placement of a catheter either with the hydrolocalization technique (group HLOC) or a neurostimulating catheter (group NS).

Eligibility criteria: Inclusion Criteria:

* adults
* BMI less than 30

Exclusion Criteria:

* known allergies to local anesthetics or other drugs used
* patient refusal
* any local or systemic contraindication to the use of popliteal block

Primary outcomes:
measure: local anesthetic consumption
timeFrame: 36 hours postoperatively
Secondary outcomes:
measure: Pain scores with a VAS scale
timeFrame: 36 hours postoperatively
Other outcomes:
measure: incidence of side effects, consumption of iv analgesics
timeFrame: 36 hours postoperatively
Locations:
city: Athens
country: Greece
facility: Attikon Hospital
city: Rome
country: Italy
facility: Policlinico Tor Vergata
Study officials:
affiliation: Attikon Hospital
name: Tatiana F Sidiropoulou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Attikon Hospital
name: Theodosios Saranteas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinico Tor Vergata
name: Mario Dauri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saranteas T, Adoni A, Sidiropoulou T, Paraskeuopoulos T, Kostopanagiotou G. Combined ultrasound imaging and hydrolocalization technique for accurate placement of perineural catheters. Br J Anaesth. 2011 Dec;107(6):1008-9. doi: 10.1093/bja/aer375. No abstract available.
Clinical trial NCT03210792: Comparison Manufactured Rib Splint With Hand-made Rib Splint
Official title: Comparison of the Effectiveness in Pain Reduction Between a Rib Splint Produced in the ER and a Manufactured Rib Splint: Preliminary Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Acute
Lead sponsor: Hanyang University
Sponsor class: OTHER
First posted: 2017-07-07
Enrollment: 12
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: A pilot study for a prospective randomized clinical trial was conducted to compare subjects using the CCO (Group-A) with those using the ER-splint (Group-B) before and after the intervention.

The primary outcome was difference in the level of pain based on the visual analogue scale (VAS) between before and after intervention in each group during forceful and resting respiration.

VAS : Visual analogue scale CCO : Chrisofix® Chest Orthosis

Detailed description: Investigators performed VAS assessments to determine the level of pain in the subjects with RFs during resting and forceful respiration. Investigators applied either the CCO rib splint or the ER splint to the RF subjects in a randomized order. At 30 minutes after splint application, investigators repeated the VAS assessments during resting and forceful respiration. Subsequently, additional pain control was provided via intravascular drug injection.

RF : Rib fractures VAS : Visual analogue scale CCO : Chrisofix® Chest Orthosis

Eligibility criteria: Inclusion Criteria:

* Subjects who have rib fractures and age was over 18 years old

Exclusion Criteria:

* Investigators excluded subjects with cardiopulmonary dysfunction, poly-trauma, flail chest, damage to an internal organ, or alcoholism and subjects who did not consent to participate.

Primary outcomes:
measure: The effectiveness of each intervention based on the VAS scores in each group during resting and forceful respiration
timeFrame: We check a pain scale at 30 minutes after splint application
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00833092: Magnesium Nutrition and Sleep Behavior in Older Adults
Official title: Magnesium Nutrition and Sleep Behavior in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Deficiency
Insomnia
Keywords: magnesium
Nutritional Requirements
Sleep
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2009-01-30
Enrollment: 111
Sex: ALL
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Insomnia is not a natural part of aging but is higher in older adults because of a variety of factors common in later life. One of these factors may be a deficient magnesium status. This study will look at whether or not magnesium supplementation will improve sleep.

Detailed description: Insomnia affects approximately one-third of older Americans. More than half of all people aged 65 and older experience sleep problems. The prevalence of insomnia and other sleep disorders is not a natural part of aging but is high in older adults because of a variety of factors common in late life. One of those factors may be a deficient magnesium status. There is a close association between sleep architecture, especially slow wave sleep, and activity in the glutamatergic and gamma-aminobutyric acid (GABA) system. Because magnesium is a natural N-methyl-D-aspartate (NMDA)antagonist and GABA agonist, magnesium apparently plays a key role in the regulation of sleep. Such a role is supported by supplementation, correlation, and animal studies showing that magnesium intake or status affects sleep organization.

Eligibility criteria: Inclusion Criteria:

* have sleep complaints
* Score greater than 5 on Pittsburgh Global Sleep Quality Index

Exclusion Criteria:

* taking medications that affect sleep
* taking 100 milligrams or more of magnesium
* body mass index of 40 or higher
* abnormal breathing conditions

Primary outcomes:
measure: Global Pittsburgh Sleep Quality Index
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Forrest H Nielsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foley DJ, Monjan AA, Brown SL, Simonsick EM, Wallace RB, Blazer DG. Sleep complaints among elderly persons: an epidemiologic study of three communities. Sleep. 1995 Jul;18(6):425-32. doi: 10.1093/sleep/18.6.425.
citation: Hunt CD, Johnson LK. Magnesium requirements: new estimations for men and women by cross-sectional statistical analyses of metabolic magnesium balance data. Am J Clin Nutr. 2006 Oct;84(4):843-52. doi: 10.1093/ajcn/84.4.843.
citation: Ford ES, Mokdad AH. Dietary magnesium intake in a national sample of US adults. J Nutr. 2003 Sep;133(9):2879-82. doi: 10.1093/jn/133.9.2879.
Clinical trial NCT05371392: Polymorphism of ITGA4 Gene in Chronic Lymphocytic Leukemia
Official title: Polymorphism of the ITGA4 Gene (Integrin Subunit Alpha 4) in Chronic Lymphocytic Leukemia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: newly diagnosed patients with Chronic lymphocytic leukemia

Brief summary: Chronic lymphocytic leukemia (CLL) is a clonal lymphoproliferative disorder that is characterized by heterogeneous presentation at the clinical and molecular levels. ITGA4 protein has been found to be deregulated in CLL with adverse clinical outcome. ITGA4 gene (CD49d) encodes a member of the integrin alpha chain family of proteins and is considered a negative prognosticator in CLL with aggressive course and short time to treatment.

The aim of the study:

is to investigate ITGA4 gene expression pattern in CLL.


Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed CLL.

Exclusion Criteria:

* ▪ Patients previously diagnosed as CLL and received treatment before.

  * Patients with other solid tumors.

Primary outcomes:
measure: ITGA4 gene expression pattern in chronic lymphocytic leukemia
timeFrame: 1 year following the startpoint of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university
Study officials:
affiliation: Sohag University
name: Amer Ahmed Youssif
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01389492: The Effect of Meat and Food Drived Polyphenols on Oxidize LDL Level
Official title: Nutritional Study:The Effect of Meat and Food Drived Polyphenols on Oxidize LDL Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: meat
LDL
MDA
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-07-08
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The postprandial increase in MDA level following meat meal could cause modification to LDL particles in healthy volunteers. Co-consumption of food drived polyphenols with the meat will result in a significant decrease in LDL modification.


Eligibility criteria: Inclusion Criteria:

* Healthy adults, normal BMI

Exclusion Criteria:

* Metabolic disorders
* Smokers
* Drinkers
* Taking nutritional supplement

Primary outcomes:
measure: Change in plasma MDA levels following meat meal
timeFrame: Fasting before meal and 3, and 6 h postprandial, and fasting levels
measure: Changes in MDA concentration on LDL fraction following meat meals
timeFrame: Fasting, before meal was eaten, 3 h following meal, at day 4, 3 h following meal consumption, and day 5 following over nigth fast
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: The Hebrew University of Jerusalem
Study officials:
affiliation: Hebrew University of Jerusalem
name: Shlomit Gorelik, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01330992: Human Circadian Sensitivity to Very Short Light Pulses
Official title: Human Circadian Sensitivity to Very Short Light Pulses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circadian Rhythm Disorders
Keywords: Circadian rhythms
Melatonin
Ocular light exposure
Darkness Exposure
Performance
Alertness
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2011-04-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The mammalian eye serves both visual and non-image-forming functions. New information about the non-image-forming anatomy and physiology of the eye has revealed effects of ocular light stimuli on human circadian rhythms, melatonin suppression, heart rate, pupillary reflexes, cognitive performance, alertness and sleep. The results of the proposed work can be used to make predictions about the effects of light, to make recommendations involving exposure to or avoidance of light, and to design environmental lighting, resulting in improved health and alertness and decreased errors and accidents.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* No medications
* No eye disease
* No sleep disorders
* No psychiatric disorders

Primary outcomes:
measure: Circadian Phase (hours)
timeFrame: Before and after intervention (day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT06761092: Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children
Official title: Nebulized Dexmedetomidine to Reduce Post-Anesthesia Delirium of Sevoflurane in Preschool Children Undergoing Elective Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Emergence Delirium
Delirium - Postoperative
Keywords: nebulized
dexmedetomidine
post anesthesia delirium
sevoflurane
preschool
Lead sponsor: Udayana University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 72
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pediatric preschool, age 2-6 years old, undergoing elective general surgery
Primary purpose: TREATMENT

Brief summary: Analyzing the effectiveness of nebulized dexmedetomidine 2 mcg/kg in reducing the incidence of post-anesthesia delirium in preschool children undergoing elective surgery with sevoflurane inhalation general anesthesia.

Researchers will compare nebulized Dexmedetomidine to a placebo (a look-alike substance that contains no drug) to see if the drug can reduce post anesthesia delirium incidence.

Detailed description: participant will : Nebulized with the anesthetic drug dexmedetomidine at a dose of 2 mcg/kg body weight, diluted to 3 ml with 0.9% normal saline, is administered before the induction of anesthesia in the reception area.

After the anesthesia, primary data collection is conducted by recovery room staff who are blinded to the treatment and control groups. Data includes scores or levels of post-anesthesia delirium or agitation assessed using the pediatric anesthesia emergence delirium score (PAED score) in the recovery room.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients aged 2 to 6 years old.
* Planned general anesthesia using inhalation sevoflurane with endotracheal tube techniques
* Parents agree to participate in the study

Exclusion Criteria:

* Pediatric patients with \> ASA II.
* Difficult airway management.
* Emergency surgery.
* Congenital abnormalities of vital organs.
* Malnutrition
* history or diagnosed with mental or cognitive disorders.
* History of upper respiratory infection within 2 weeks before the procedure.
* History of allergy to dexmedetomidine.
* Surgery duration estimation exceeding 180 minutes.
* Parents refuse to participate in the study

Primary outcomes:
measure: reduce post anesthesia delirium incidence
timeFrame: 120 minutes (after extubation till discharge from recovery room)
Secondary outcomes:
Other outcomes:
Locations:
city: Denpasar
country: Indonesia
facility: Anesthesiology and Intensive Therapy Udayana University
state: Bali
Study officials:
References:
Clinical trial NCT00497692: Topic Compatibility Lactoserum (Dermacyd Delicata - New Fragrance)
Official title: Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability and Dermical Sensitivity) for Dermacyd Femina Delicata
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-07-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Femina Delicata.


Eligibility criteria: Inclusion Criteria:

* Phototypes: I, II, III and IV
* Integral skin test in the region

Exclusion Criteria:

* Pregnancy or breastfeeding women
* Use of antinflammatory or immune-suppression drugs
* Personal history of atopy
* History of sensibilization or irritation for topic products
* Active cutaneous disease
* Use of new drugs and/or cosmetics during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Score evaluation of the cutaneous reaction, preconized by International Contact Dermatitis Research Group (ICDRG)
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Sanofi-aventis
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT03924492: Expanded Access Protocol of ZULRESSO™ (Brexanolone) Injection for Adult Patients With Postpartum Depression
Official title: Expanded Access Protocol of ZULRESSO for Adult Patients With Postpartum Depression
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Postpartum Depression
Keywords: Expanded Access
Lead sponsor: Sage Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-04-23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an expanded access program intended to provide access to ZULRESSO™ (brexanolone) injection for the treatment of a limited number of eligible women with postpartum depression during the period prior to commercial availability. Requests for access must be made by a healthcare provider for a specific patient based on a determination with patient that the benefits of treatment outweigh the risks and an assessment of eligibility based on program criteria. Sites with eligible patients must apply and meet requirements for participation in the expanded access program.


Eligibility criteria: Inclusion Criteria:

1. Subject has signed an informed consent form prior to any study-specific procedures being performed
2. Subject is an ambulatory female at least 18 years of age
3. Subject agrees to adhere to the study requirements
4. Subject agrees not to be the primary caregiver of any dependents during the infusion
5. Subject must have a negative pregnancy test on Day 1 prior to the start of the ZULRESSO infusion
6. Subject has a current diagnosis of PPD, as assessed by the Investigator

Exclusion Criteria:

1. Subject has end stage renal disease
2. Subject has a known allergy to progesterone or allopregnanolone

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06441292: Multi-Modal Image Fusion for Precision Prostate Biopsy Navigation
Official title: Study on Prostate Targeted Biopsy Precision Navigation Method Based on Multi-Modal Image Fusion Deep Learning Using Multi-Parameter Ultrasound and MRI
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
targeted biopsy
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 602
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is a prospective randomized controlled clinical trial aimed at comparing the detection rates of clinically significant prostate cancer between conventional biopsy methods and AI-assisted biopsy methods in patients undergoing initial prostate biopsy who meet the indications for prostate biopsy.

Detailed description: This study is a prospective randomized controlled clinical trial designed to investigate the efficacy of AI-assisted biopsy methods compared to conventional biopsy methods in detecting clinically significant prostate cancer. The target population includes patients undergoing their initial prostate biopsy who meet established indications for prostate biopsy.

Eligibility criteria: Inclusion Criteria:

1. Age \> 18
2. PSA \> 4 ng/ml and/or abnormal DRE
3. Sign the informed consent

Exclusion Criteria:

1. Have acute or chronic prostatitis
2. Contraindications to prostate biopsy
3. Contraindications to MRI
4. Other reasons that not suitable for this trial

Primary outcomes:
measure: The detection rate of clinically significant prostate cancer by targeted biopsy alone
timeFrame: 2-3 weeks post-biopsy
Secondary outcomes:
measure: The detection rate of clinically significant prostate cancer by targeted biopsy combined with template biopsy
timeFrame: 2-3 weeks post-biopsy
measure: The detection rate of any prostate cancer by targeted biopsy alone
timeFrame: 2-3 weeks post-biopsy
measure: The detection rate of any prostate cancer by targeted biopsy combined with template biopsy
timeFrame: 2-3 weeks post-biopsy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital, Tongji University School of Medicine
Study officials:
References: