louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05394389: The Complementary Contributions of Sensory Stimulation and Social Support During Snoezelen Room Therapy on the General Physical and Emotional Health of the Elderly Population: Optimization of the Nursing Home Resources.
Official title: The Complementary Contributions of Sensory Stimulation and Social Support During Snoezelen Room Therapy on the General Physical and Emotional Health of the Elderly Population: Optimization of the Nursing Home Resources.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Loneliness
Aging
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Over time, lifespan is extending, the population is aging, and accordingly there is a great demand for hospital beds in nursing homes, increasing attention to this population and the services they receive. Mostly, elderly population living in nursing homes suffers from dementia, Alzheimer, depression, agitation, and other diseases that require multidisciplinary treatment.

In addition to the medical and pharmacological treatments that patients receive to maintain functional medical status, there is a great need for non-pharmacological treatments, that may improve quality of life, mental well-being, and life satisfaction.

There are several treatment approaches of multisensory stimulation environment (MSSE). MSSE in the Snoezelen room therapy recognized as benefiting the patients' physical, mental, and emotional health status. In addition, there is great importance of intervention by social interaction, support, and encouragement.

However, the effect of combined intervention of MSSE in Snoezelen room therapy and social support, has not yet been sufficiently studied in elderly patients in nursing homes. These two interventions - together - are supposed to have an increased effect on physical and mental wellbeing of elderly.


Eligibility criteria: Inclusion Criteria:

* Patients living in the Ahuzat Moriah nursing home\\ geriatric nursing hospital in Shefar'am.

Exclusion Criteria:

* Patients with epilepsy and aggressive patients. \*We do not limit the participation of patients whose cognitive level is very low.

Primary outcomes:
measure: pain, patient- reported outcome, measured by a ruler from zero to 10, on the Likert scale
timeFrame: four weeks
measure: grip strength
timeFrame: eighteen minutes
measure: life satisfaction, patient-reported outcome.
timeFrame: four weeks
measure: general anxiety disorder, patient- reported outcome
timeFrame: four weeks
measure: blood pressure
timeFrame: eighteen minutes
Secondary outcomes:
measure: pulse(heart rate index)
timeFrame: eighteen minutes
measure: oxygen saturation
timeFrame: eighteen minutes
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Ahuzat Moriah Shfraam
state: North
Study officials:
References:
Clinical trial NCT05841589: Evaluation of Antimicrobial Efficacy of Green Tea, Garlic With Lime, Pomegranate Extract and Chlorhexidine Mouth Rinses in a Group of Egyptian Children (In-Vivo Study)
Official title: Evaluation of Antimicrobial Efficacy of Green Tea, Garlic With Lime, Pomegranate Extract and Chlorhexidine Mouth Rinses in a Group of Egyptian Children (In-Vivo Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: herbal mouth rinses
Pomegranate
Caries prevention
Garlic extract
Green tea extract
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 84
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the four groups of the mouth rinses were done in parallel with each other
Primary purpose: PREVENTION

Brief summary: the aim of the clinical trial is to evaluate the antimicrobial efficacy of the herbal mouth rinses against chlorhexidine mouth rinse.

Detailed description: The present study was carried out on 84 children. Children were recruited based on certain inclusion criteria after signing a written informed consent by their parents. They were divided into 4 groups. Group (I) the children rinsed with Chlorhexidine mouth rinse, the child rinsed for 1 minute and plaque samples were collected from the child before and after rinsing. Group (II) children rinsed with green tea extract, while group (III) children rinsed with garlic with lime extract and group (IV) the children rinsed with pomegranate extract mouth rinse with the same procedures. .child satisfaction was measured using 5-point pictorial likert scale which is graded from 1 to 5 (1.Excellent.2.Good.3 Average 4.Poor. 5. Very poor).

All the plaque samples were collected and put in sterile test tubes containing thioglycolate as a transport media. They transferred to the microbiology laboratory within half an hour after rinsing for detection of bacterial counts. These samples were incubated 48-96 hours at 37°C. Number of bacterial colonies were counted by hand-held digital colony counter.

Eligibility criteria: Inclusion Criteria:• Age 5-8 years.

* No history of systemic disease.
* Patients didn't received antibiotics for at least 3 months before and during the study

Exclusion Criteria:• Children who can't expectorate completely or brush their teeth on their own.

* Fixed or removable orthodontic appliances.
* Children with intra oral abscess, oral lesions or gingival diseases.
* Parental consent was not acquired

Primary outcomes:
measure: patient satisfaction
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
measure: bacterial count
timeFrame: 1 day after rinsing
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shmas University
Study officials:
References:
Clinical trial NCT01465789: Noninvasive Biomarkers for Monitoring Cardiometabolic Risk in Children
Official title: Noninvasive Biomarkers for Monitoring Cardiometabolic Risk in Children
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obesity
Metabolic Syndrome
Lead sponsor: West Virginia School of Osteopathic Medicine
Sponsor class: OTHER
First posted: 2011-11-06
Enrollment: 33
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children participating in the CARDIAC Boot Camp program at the Robert C. Byrd Clinic in Lewisburg WV

Brief summary: The purpose of this study is to identify salivary biomarkers for monitoring cardiometabolic risk in children. The study hypothesis is that a combination of salivary biomarkers will predict the presence of risk factors including impaired fasting glucose, hypertension and dyslipidemia and will reflect changes in these risk factors over time.


Eligibility criteria: Inclusion Criteria:

* Participating in the CARDIAC Boot Camp Program
* Between the ages of 4 and 17
* Parental permission
* Ability to provide assent

Exclusion Criteria:

* Inability to comply with saliva collection procedures
* Renal insufficiency or juvenile gout

Primary outcomes:
measure: Correlation (R values) of salivary biomarkers with blood pressure percentile and serum glucose, HDL, total cholesterol, triglyceride and insulin levels in children
timeFrame: Baseline
measure: Predictive utility (C-statistic) of salivary biomarkers for development of metabolic syndrome during childhood and adolescence
timeFrame: final assessment at age 18 (up to 14 years depending on age of enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: Lewisburg
country: United States
facility: West Virginia School of Osteopathic Medicine
state: West Virginia
Study officials:
affiliation: West Virginia School of Osteopathic Medicine
name: Kristie G Bridges, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: West Virginia School of Osteopathic Medicine
name: Jill Cochran, PhD, MSN, RN-C FNP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02001389: Study of EVP-6308 to Assess the Dose- and Concentration-dependent Displacement of [18F]MNI-659 by EVP-6308
Official title: A Phase 1, Open-Label, Multiple Ascending Dose, [18F]MNI-659 PET-Imaging Study to Evaluate PDE10A Occupancy After Dosing With EVP-6308 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Enzyme occupancy
Positron emission tomography (PET)
Phosphodiesterase 10 inhibitor
Lead sponsor: FORUM Pharmaceuticals Inc
Sponsor class: INDUSTRY
First posted: 2013-12-04
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is an open-label, single-arm, multiple ascending dose Phase I study to assess the dose- and concentration-dependent displacement of \[18F\]MNI-659 \[a PET tracer targeting phosphodiesterase 10 (PDE10)\] by EVP-6308.


Eligibility criteria: Inclusion Criteria:

• Healthy male or female volunteers, 18 to 50 years of age

Exclusion Criteria:

* Clinically significant abnormalities on physical examination, medical history, ECG , vital signs, laboratory values, or unstable medical or psychiatric illness
* Any disorder that may interfere with drug absorption.
* Clinically significant allergy or sensitivity to medications Positive test for human immunodeficiency virus (HIV) antibodies, Hepatitis B surface antigen, or Hepatitis C antibody.
* Pregnant or breast feeding.
* History of exposure to any radiation \>15 mSv/year (e.g., occupational or radiation therapy) over the past year.

Primary outcomes:
measure: Target occupancy of [18F]MNI-659.
timeFrame: Baseline and Day 3
Secondary outcomes:
measure: Safety of EVP-6308 as assessed by adverse events, vital signs, clinical laboratory tests, C-SSRS, and electrocardiogram (ECG).
timeFrame: Baseline to Day 4 or Early Termination
measure: Pharmacokinetics of EVP-6308 and EVP-6308 N-oxide.
timeFrame: Day 3
Other outcomes:
Locations:
city: New Haven
country: United States
state: Connecticut
Study officials:
References:
Clinical trial NCT01469689: Raising Awareness of Online Therapies for Depression: Pilot Study
Official title: Raising Awareness of Online Therapies for Depression: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Keywords: People
living
community
Lead sponsor: University of Plymouth
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2011-11-10
Enrollment: 8231
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Web based cognitive behavioural therapy (webCBT) for depression is recommended by NICE but analysis of the geographic distribution of one webCBT site showed 15-fold variation in use across Britain. Such variation is unlikely to be from differences in prevalence. Raising awareness of webCBT could benefit many people with depression but it is not clear how direct-to-patient promotion online or via the media, compares with GP centred methods. This pilot cluster randomised controlled trial will explore the use of online methods to raise awareness in preparation for subsequent study comparing different approaches.

In a pilot cluster randomised trial the investigators will explore the feasibility and likely impact of online methods of raising awareness of webCBT, assessing how many people with depression respond to geographically restricted Google and local website advertisements. The investigators will explore costs of recruitment and define and document the best online methods that might subsequently be used in a definitive trial comparing online with mass media and GP centred methods for raising awareness. The investigators will compare intervention with control areas to estimate impact on registration levels and compare rate of completion of webCBT of these 'additional' registrants with other registrants. Recommendations will be made for a subsequent trial comparing online with other methods.


Eligibility criteria: Inclusion Criteria:

* people living in Britain searching for online help for depression

Exclusion Criteria:

Primary outcomes:
measure: Registration on Living Life To The Full website
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: Online
Study officials:
References:
citation: Jones RB, Goldsmith L, Hewson P, Williams CJ. Recruitment to online therapies for depression: pilot cluster randomized controlled trial. J Med Internet Res. 2013 Mar 5;15(3):e45. doi: 10.2196/jmir.2367.
citation: Jones RB, Goldsmith L, Williams CJ, Kamel Boulos MN. Accuracy of geographically targeted internet advertisements on Google AdWords for recruitment in a randomized trial. J Med Internet Res. 2012 Jun 20;14(3):e84. doi: 10.2196/jmir.1991.
citation: Jones RB, Goldsmith L, Hewson P, Kamel Boulos MN, Williams CJ. Do adverts increase the probability of finding online cognitive behavioural therapy for depression? Cross-sectional study. BMJ Open. 2012 Apr 16;2(2):e000800. doi: 10.1136/bmjopen-2011-000800. Print 2012.
Clinical trial NCT05274789: Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Robot-assisted Pancreaticoduodenectomy: a Randomized Controlled Study
Official title: Effect of Intraoperative Dexmedetomidine on Postoperative Delirium in Elderly Patients Undergoing Robot-assisted Pancreaticoduodenectomy: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delirium in Old Age
Keywords: dexmedetomidine
robot-assisted pancreaticoduodenectomy
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tiantan Hospital
First posted: 2022-03-10
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To observe the effect of intraoperative dexmedetomidine on the incidence of postoperative delirium, postoperative analgesic drug requirements and pain scores in elderly patients undergoing robot-assisted pancreaticoduodenectomy.

Detailed description: This study is a multicenter, randomized, double-blind, placebo-controlled trial. Three hundred patients undergoing elective robotic-assisted pancreaticoduodenectomy were randomized to the intervention and control groups. Patients in the intervention group were given a loading dose of 0.6 μg/kg of dexmedetomidine by intravenous infusion within 10 minutes after intubation, followed by a continuous infusion at a rate of 0.4 μg/kg/h until 30 min before the end of the procedure; patients in the control group were given an equal volume of saline. Data were collected at 1-5 days and 1 month postoperative follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients over 65 years old
* Patients undergoing elective robotic-assisted pancreaticoduodenectomy.
* Written informed consent was obtained.

Exclusion Criteria:

* Patients with severe preoperative cognitive impairment (MMSE ≤ 20) who are unable to undergo a follow-up evaluation.
* Patients with history of psychiatric or neurological disorders.
* Patients with body mass index ≤ 18 or ≥ 30
* Pregnant or lactating women
* Patients with severe bradycardia (heart rate less than 40 beats per minute)
* Patients with pathological sinus node syndrome or grade 2 or greater AV block
* Patients with severe hepatic or renal insufficiency.
* Patients with severe hypertension (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg)

Primary outcomes:
measure: Incidence of postoperative delirium
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 5 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital,Capital Medical University
Study officials:
affiliation: Chinese PLA General Hospital
name: Hao Li, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00762489: Comparison of Three Methods of Taking Temperatures in the Well Baby Nursery
Official title: Comparison of Temporal Artery, Axillary, and Rectal Temperatures in Newborn Patients in the Well Baby Nursery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn Infants
Keywords: Temporal artery thermometry
Rectal temperature
Axillary temperature
Newborns
Temperature measurement
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
First posted: 2008-09-30
Enrollment: 104
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Body temperature measurement is one of the standard vital sign measurements in newborn babies in order assess their health status. Temperatures are taken on a regular basis throughout the newborn's stay on the well-baby floor. A temperature that is elevated above the normal range for age or depressed below the normal range for age may be a sign of illness in a newborn. There are many methods that may be used to record this temperature. Traditionally, axillary (under the arm) and rectal (in the rectum) sites have been used. Recently, a new method of temperature measurement has become available. Temporal artery thermometers are a non-invasive method to measure the baby's temperature by means of a light that is shone on the forehead that can read your baby's temperature quickly. It is not clear whether this method is accurate in the newborn period.

The purpose of this study is to evaluate the accuracy of temporal artery temperature measurement. This will be achieved by observing the axillary measurement, rectal temperature measurement, and temporal artery temperature measurement taken at approximately the same time in each infant. These measurements will be compared to each other to determine if temporal artery thermometry is as reliable a measurement as rectal and / or axillary temperature measurements.

We plan to compare

Hypothesis: Temporal artery thermometry of the immediate newborn infant is an accurate measurement of temperature in this age group.


Eligibility criteria: Inclusion Criteria:

* term newborns \>/= 37 weeks gestational age
* late preterm infants \>/= 35 weeks gestational age
* admitted to the well baby nursery following delivery
* \< 24 hours of age

Exclusion Criteria:

* Infants \< 35 weeks gestational age
* Infants currently under a radiant warmer or who have been under a radiant warmer \< 1 hour prior to temperature measurement.

Primary outcomes:
measure: Accuracy of temporal artery temperature compared to rectal and axillary temperature measurements.
timeFrame: All temperatures will be taken within 5 minutes of each other
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health Systems
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: Michael F. Bruno, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01824589: Effect of Intrathoracic Pressure Regulation on Traumatic Brain Injury
Official title: Effects of Intrathoracic Pressure Regulation Therapy in Patients With Elevated Intracranial Pressure Due to Brain Injury or Intracranial Pathology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Head Injury
Keywords: traumatic brain injury
TBI
ITPR
intrathoracic pressure regulator
hepatic encephalopathy
pseudotumorcerebri
obstructive hydrocephalus
intracranial hemorrhage
Lead sponsor: Advanced Circulatory Systems
Sponsor class: INDUSTRY
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2013-04-05
Enrollment: 1
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate proof of clinical concept that application of the Intrathoracic Pressure Regulator (ITPR) will result in an increase in Cerebral Perfusion Pressure (CPP) and a decrease in Intracranial Perfusion Pressure (ICP) in patients with head injury and elevated ICP, and to determine the optimal ventilation tidal volume (TV).


Eligibility criteria: Inclusion Criteria:

* ≥15 years of age
* intubated and mechanically ventilated on a volume controlled mode
* head injury or other intracranial pathology with ICP of ≥15 mmHg
* arterial line in place
* SpO2 ≥95%
* MAP \>60
* in ICU or about to undergo neurosurgery with planned placement of an ICP monitor
* inclusion presents no significant delays to planned emergent neurosurgery
* prior written informed consent

Exclusion Criteria:

* cardiac or pulmonary injury impacting intrathoracic pressure
* confirmed pneumothorax or hemothorax
* PaO2/FiO2 \<300
* serious neck injury resulting in neck swelling with jugular venous compression
* evidence of ongoing uncontrolled bleeding
* respiratory disease such as COPD, interstitial lung disease, or other parenchymal or pulmonary vascular disease
* congestive heart failure

Primary outcomes:
measure: Intracranial Pressure (ICP)
timeFrame: 15 minutes after device is activated
Secondary outcomes:
measure: Cerebral Perfusion Pressure (CPP)
timeFrame: 15 minutes after device activation
measure: Lung Compliance
timeFrame: baseline and immediately after device removal
measure: Arterial Blood Gases (PaCO2)
timeFrame: 15 minutes after device activation
Other outcomes:
Locations:
Study officials:
References: