louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04145414: Cerebrospinal Fluid Movements Through Interventricular Foramina in Phase Contrast Magnetic Resonance Imaging (PC-MRI)
Official title: Cerebrospinal Fluid Movements Through Interventricular Foramina in Phase Contrast Magnetic Resonance Imaging (PC-MRI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CSF Circulation Disorder
Foramen; Monro, Obstruction
Mri
Keywords: CSF
PC-MRI
interventricular foramina
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Assess the reproductibility of PC-MRI for cerebrospinal fluid movements through the interventricular foramina on volunteer subjects.

Detailed description: It is a monocentric interventional prospective study. Each subject will have to pass two MRI. Phase contrast MRI (PC-MRI) will be calibrated for each subject by assessing the optimal encoding velocity. Three sequences including the aqueduct and the two interventricular foramina (IVF) will be done. The signal will be analysed by syngo.via software after defining by two different investigators the region of interest (ROI) which correspond to the IVF or the aqueductal lumen. Descriptive statistics will test the intra-individual and inter-observer consistency based on 4 flow parameters.

Eligibility criteria: Inclusion Criteria:

* Mini-Mental State Examination score \> 28/30

Exclusion Criteria:

* MRI contraindication
* Medical or surgical history related to following pathologies: nervous system disease, cardiac arrhythmia, cardiac or respiratory insufficiency.
* Long-term medical treatment
* Ongoing pregnancy

Primary outcomes:
measure: PC-MRI procedure reproductibility
timeFrame: week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
affiliation: CHU Besançon
name: Laurent TATU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02036814: Program for Health Promotion to Improve Therapeutic Compliance in Hypertensive Patiente
Official title: A PROGRAM OF HEALTH EDUCATION PROMOTION BY NURSING CAN IMPROVE BLOOD PRESSURE CONTROL AND QUALITY OF LIFE IN HYPERTENSIVE PATIENTS?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Nursing
Therapeutic compliance
Quality of life
Health education
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: InCor Heart Institute
First posted: 2014-01-15
Enrollment: 21
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim was to test if interpersonal relationships group strategies provided by nursing can promote an additional benefit on blood pressure (BP) control and quality of life (QoL) in hypertensive patients. Methods: 21 treated patients were randomized into two groups: Group A 10 patients (8 women), underwent to a health educational orientation program (inter-relational strategy), with group meetings every 15 days during 4 months(8 meetings). Group B 11 patients (7 women), who underwent group orientation by the nurse every 40 days during 4 months (3 meetings). Both groups received the same content guidelines (healthy lifestyle and prevention of risk factors). The patients had 2 visits by nurses at baseline (15 days) and at the final study (120 days). BP was measured by auscultatory method and QoL questionnaire (WHOQoL-Brief)was applied. The dispensing and pill counts were done every 30 days. Ambulatory blood pressure monitoring (ABPM) was performed at baseline and after 120 days.


Eligibility criteria: Inclusion criteria:

* Hypertensive patients under treatment regimen;
* Pressure levels greater than or equal to 90 mmHg diastolic blood pressure (DBP), and
* Pressure level greater than or equal to 140 mmHg systolic blood pressure (SBP)
* Age limit between 25 to 75 years, for both female and male.

Exclusion Criteria:

* Diabetes patients

Primary outcomes:
measure: measure blood pressure arterial
timeFrame: 4 months
Secondary outcomes:
measure: QoL questionnaire (WHOQoL-Brief)
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Heart Institute of Medicine School of University of São Paulo
name: Heno Ferreira Lopes, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01415414: Observational Study of Ultravist in Patients Requiring CECT
Official title: The Image Quality and Radiation Dose of CECT With Ultravist® in Patients With Abdominal Pelvic Disease - INDEX
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnostic Imaging
Keywords: Image quality
CNR
SNR
Abdominal
Pelvic
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-08-12
Enrollment: 11660
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing contrast enhanced CT Imaging with Ultravist (iopromide) in abdomen and pelvis, including relevant vessels

Brief summary: It is a prospective, non-interventional, multi-center study. The primary objective of this study is to evaluate the image quality of Ultravist in patients requiring contrast-enhanced CT considering the routine use in patient population's, region's indication.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing contrast enhanced CT Imaging with Ultravist (iopromide) in abdomen or pelvis.

Exclusion Criteria:

* There is no other exclusion criteria beyond the contraindications contained in the Summary of Product Characteristics

Primary outcomes:
measure: Image quality evaluated by calculated CNR (Contrast to Noise Ratio)
timeFrame: 1 day
Secondary outcomes:
measure: Image quality evaluated by calculated SNR (Signal Noise Ratio)
timeFrame: 1 day
measure: Descriptive analysis of contrast medial injection protocol
timeFrame: 1 day
measure: Radiation dose (CTDIvol)
timeFrame: 1 day
Other outcomes:
Locations:
city: Many locations
country: China
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04926714: Ophthalmologic Evaluation of Patients With Obesity and Metabolic Syndrome Before and After Bariatric Surgery
Official title: Ophthalmologic Evaluation of Patients With Obesity and Metabolic Syndrome Before and After Bariatric Surgery:A Pilot, Monocentric, Prospective, Open-label Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eye Diseases
Obesity Associated Disorder
Lead sponsor: First Affiliated Hospital of Jinan University
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Patients with BMI≥32.5Kg/m2Or patients with BMI27.5-32.5Kg/m2, combined with metabolic diseases;
2. Subjects understand the purpose of the clinical study and are willing, able and committed to return to the study center for all clinical study visits and to complete all study procedures.

Brief summary: The aim of this study was to investigate the pathogenic role of obesity on blinding eye diseases in a population of severely obese patients with no history of eye diseases, and to verify whether weight loss induced by bariatric surgery may have a protective effect.

Detailed description: This was a pilot, monocentric, prospective, and open label study conducted at First Affiliated Hospital of Jinan Universityreceived.Patients with body mass index ≥ 32.5Kg/m2; or patients with body mass index of 27.5-32.5Kg/m2 and metabolic diseases were consecutively recruited.All participants underwent complete ophthalmological evaluation， Keratograph 5M and optical coherence tomography.Patients who underwent bariatric surgery were evaluated also 3 months, 6 months and 1 year after surgery.

Eligibility criteria: Inclusion Criteria:

1. Patients with BMI≥32.5Kg/m2；
2. patients with BMI27.5-32.5Kg/m2, combined with metabolic diseases;

Exclusion Criteria:

1. Patients with pre-existing ocular diseases or visual alterations were excluded to avoid confounding factors related to pre-existing retinal pathology, independent from obesity per se.
2. Patients with dementia, Parkinson's disease, Alzheimer's disease, multiple sclerosis or other severe neurological diseases were also excluded since ophthalmologic parameters may be altered in these conditions.
3. Patients with lens opacities that made impossible the posterior segment examination, or with a refractive error \> +5 or \<-8 diopters spherical equivalent were also excluded.

Primary outcomes:
measure: optical coherence tomography
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
Study officials:
References:
Clinical trial NCT05970614: The Effect of Eye Masks and Earplugs In Intensive Care Unit Patients
Official title: The Effect of Eye Masks and Earplugs on Sleep Quality and Life Findings In Intensive Care Unit Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Quality
Vital Signs
Keywords: sleep quality
vital signs
intensive care
ear plugs
eye masks
Lead sponsor: Osmaniye Korkut Ata University
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial with control and intervention groups
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned as a randomized controlled and experimental study to evaluate the effect of eye masks and earplugs on sleep quality and vital signs in intensive care patients.

Detailed description: The research will be conducted with 60 patients hospitalized in the intensive care units of a state hospital. Research data will be collected with a questionnaire, vital signs follow-up form, insomnia severity index, and Richards-Campbell Sleep Quality Scale. Patients will be divided into intervention and control groups. Eye mask and ear plugs will be applied to the intervention group for 3 days, and the control group will receive routine care. The study will be terminated after 3 days of follow-up for each patient.

Eligibility criteria: Inclusion Criteria:

* 18 years and over,
* Able to answer all questions and communicate,
* Those who agreed to participate in the research
* Being in the category of insomnia, moderate insomnia, or severe insomnia according to the insomnia severity index,
* Not sedating
* Not connected to a ventilator
* No hearing problem
* Glasgow Coma Score of 15

Exclusion Criteria:

* Connecting to the ventilator during operation
* Sedation during the study
* Wanting to leave the research during the study
* Being in the intervention group and removing the eye patch or earplug during sleep
* GCS falling below 15

Primary outcomes:
measure: Personal questionnaire
timeFrame: Only one times. At the first meeting (up to one day).
measure: Vital signs follow-up form
timeFrame: up to 3 days
measure: Insomnia Severity Index
timeFrame: up to 3 days
measure: Richards-Campbell Sleep Scale
timeFrame: up to 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Osmaniye
country: Turkey
facility: Osmaniye Public Hospital
state: Merkez
Study officials:
References:
Clinical trial NCT01629914: Executive Functioning and Mindfulness in Adults With Attention Deficit/Hyperactivity Disorder Imaging
Official title: Executive Functioning and Mindfulness in Adults With ADHD Imaging
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Attention-deficit/Hyperactivity Disorder
Keywords: Attention-deficit/hyperactivity disorder
executive functioning
mindfulness meditation
magnetic resonance imaging
healthy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2012-06-28
Enrollment: 0
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 main purpose of this study is to evaluate changes in brain functioning using an MRI machine following mindfulness meditation training.

Detailed description: The broad objective of this proposal is to identify functional neuroanatomical correlates of changes in executive brain functioning prior to and following an 8-week, group-based mindfulness meditation intervention within a group of 10 adults diagnosed with Attention-deficit/hyperactivity disorder (ADHD). Another group of 10 adults diagnosed with ADHD will be placed in the waitlist condition.

Our primary hypothesis is that adults with ADHD in the treatment group will exhibit improved performance on a series of executive functioning tasks and that exposure to task stimuli will correspond to changes in neural functioning following an 8-week, group-based mindfulness intervention. Brain responses will be measured using blood-oxygenation-level-dependent (BOLD) fMRI signal in brain regions associated with emotional and executive processes prior to and following treatment.

Eligibility criteria: Inclusion Criteria:

* ages 18-50 years
* meet DSM-IV criteria for ADHD
* intellectual functioning ≥ 80 as assessed by an IQ screener
* generally healthy (i.e., no major medical problems)

Exclusion Criteria:

* major medical condition that would make participation unsafe (e.g., have pacemaker or other metallic implant), uncomfortable (e.g., chronic pain)
* claustrophobic, or abnormally afraid of closed-in places
* current drug use

Primary outcomes:
measure: change from baseline in blood-oxygenation-level-dependent (BOLD) fMRI signal
timeFrame: baseline and 8-weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: John T Mitchell, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01808014: The Analgesic Effect of Nefopam on the Fentanyl Based PCA (Patient-controlled Analgesia) After Lumbar Spinal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Spinal Stenisis or Lumbar Herniated Intervertebral Disc
Keywords: nefopam, spinal surgery, postoperative pain control
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-03-08
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Posterior lumbar spinal surgical pain leads to a severe degree of pain, and, hence, various means of pain management are required. Opioid pain medications such as morphine and fentanyl are frequently used as intravenously administered medications. To reduce the use of opioids for pain relief, a non-opioid form of pain relief, such as a Non-Steroidal Anti-Inflammatory Drug (NSAID), is often added to the regimen.

With the use of NSAIDs, however, the risk of systemic side effects such as bleeding, gastroduodenal bleeding, and kidney damage are being reported, and there is also a report of inhibition of spinal fusion; these risks limit the use of NSAIDs.

Nefopam, a new centrally-acting analgesic agent, has been reported in an animal study to desensitize post-surgical pain, and when used with an opioid analgesic, it indirectly controlled the NMDA receptor, which inhibited the generation of c-fos gene at the spine. There are also reports that Nefopam managed pain by inhibiting the serotonin reuptake receptors.

In clinical practice, the administration of Nefopam in patients who required post-surgical pain management reduced the use of opioid analgesics by 20-50 % and also reduced the prevalence of nausea and vomiting.

Therefore, the investigators considered whether the addition of Nefopam for intravenous patient-controlled analgesia in patients with lumbar spinal surgery would reduce the side effects seen in monotherapy with opioid analgesia and result in effective pain management. This study was conducted to address this question.


Eligibility criteria: A. Inclusion criteria: The study subjects were adult patients, 20-65 years old, who were going to have spinal fusion surgery due to conditions such as spinal stenosis or disks and who fell under the American Society of Anesthesiologist physical status classifications of 1 or 2.

B. Exclusion criteria: Patients who could not read or understand the consent documents or who had a defect in blood coagulation, hepatectomy, pneumonectomy, nephrectomy, cardiovascular disease, administration of MAO inhibitor, ischuria, glaucoma, or a history of seizure were excluded from the study.

Primary outcomes:
measure: The additional analgesic effect of nefopam on the fentanyl based PCA after lumbar spinal surgery
timeFrame: up to 48 hours post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT02790814: Moyo; strap-on Fetal Heart Rate Monitoring in a Rural Setting
Official title: Evaluation of an Innovative Fetal Heart Rate Monitoring Device (Named Moyo) to Improve Perinatal Outcome at Haydom Hospital, Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Monitoring
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2016-06-06
Enrollment: 2652
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Annually, an estimated 2.6 million still births occur half of which die during labor and delivery (fresh stillbirths). In addition, around 750,000 newborns die shortly after birth due to intrapartum-related hypoxia or birth asphyxia. Almost 99% of these perinatal deaths take place in low-income countries where the provider/patient ratio is low and fetal monitoring is inadequate. Poor intrapartum fetal heart rate monitoring, failure to identify fetal distress, and subsequently intervene, is a common pathway to perinatal deaths in these low-resourced settings. Recently, an innovative fetal heart rate monitoring device, called Moyo, using ultrasound technology, was developed to be strapped on the mother during labour. This project will compare the effectiveness of automatic use of Moyo versus intermittent use of hand-held fetoscope in detection of abnormal fetal heart rate, through a randomized control study, at Haydom Hospital, Tanzania.


Eligibility criteria: Inclusion Criteria:

* Women admitted in labor

Exclusion Criteria:

* Women scheduled for elective cesarean section, women with abnormal fetal heart rate on admission, multiples, and critically ill patients with no measurements of fetal heart rate on admission

Primary outcomes:
measure: Frequency of abnormal fetal heart rate detection
timeFrame: Up to delivery
Secondary outcomes:
measure: Mode of delivery: vaginal versus operative
timeFrame: Up to delivery
measure: Neonatal outcome: dead versus alive
timeFrame: Up to 24 hours
measure: Time from abnormal fetal heart rate detection to delivery in minutes
timeFrame: Up to delivery
Other outcomes:
Locations:
city: Haydom
country: Tanzania
facility: Haydom Lutheran Hospital, Research Institute
state: Manyara
Study officials:
affiliation: Helse Stavanger HF
name: Hege L. Ersdal, Md PhD
role: STUDY_DIRECTOR
References:
citation: Mdoe PF, Ersdal HL, Mduma E, Moshiro R, Dalen I, Perlman JM, Kidanto H. Randomized controlled trial of continuous Doppler versus intermittent fetoscope fetal heart rate monitoring in a low-resource setting. Int J Gynaecol Obstet. 2018 Dec;143(3):344-350. doi: 10.1002/ijgo.12648. Epub 2018 Sep 4.
Clinical trial NCT01541514: Evaluating the Patient-Ventilator Synchrony During Mechanical Ventilation in Patients With Acute Lung Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanically Ventilated ICU Patients
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2012-03-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult ICU patients receiving mechanical ventilation

Brief summary: The overall purpose to the study is to prospectively study how often patients with and without acute lung injury (ALI) have patient-ventilator asynchrony demonstrated as stacked breaths. The investigators seek to describe the quantity of stacked breaths by continuously recording flow, volume, and pressure waveforms routinely displayed on the vent. The investigators also seek to describe how primary ICU teams manage asynchrony documenting interventions of sedation or vent manipulation and what modality is most successful.


Eligibility criteria: Inclusion Criteria:

age \> 18 years intubated and mechanically ventilated diagnosed with acute lung injury (ALI) or requiring mechanical ventilation for reasons other than ALI

Exclusion Criteria:

neurological deficits (acute or chronic) that prevent effective diaphragm activity.

* Neuromuscular disease affecting the diaphragm
* Neuromuscular blockade

Primary outcomes:
measure: double stacks
timeFrame: number per minute over 5 minutes
Secondary outcomes:
measure: level of sedation
timeFrame: baseline
measure: mode of ventilation
timeFrame: 30min
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jesse Hall, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02814214: Device-based QRS Evaluation
Official title: Device-based QRS Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2016-06-27
Enrollment: 103
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: The study will include approximately 100 patients who have been implanted with SJM Quadripolar Pacing Systems

Brief summary: The purpose of this study is to collect simultaneous surface electrocardiogram (ECG) recordings and Cardiac Resynchronization Therapy (CRT) intracardiac electrogram (IEGM) recordings of variations in electrical synchrony.


Eligibility criteria: Inclusion Criteria:

* Already implanted with SJM Quadripolar CRT Pacing System
* Ability to provide informed consent for study participation
* Willing to comply with the study evaluation requirements
* At least 18 years of age

Exclusion Criteria:

* Resting ventricular rate \>100 bpm
* Intrinsic PR interval \> 300 ms
* Paroxysmal or persistent atrial tachycardia or atrial fibrillation documented
* Pregnant or plans to become pregnant during the study

Primary outcomes:
measure: Characterize CRT IEGM-based estimations of QRS duration
timeFrame: Acute (1 day)
Secondary outcomes:
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: I.R.C.C.S. Policlinico San Donato
state: MI
Study officials:
References: