louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02516566: Effects of PEEP on Optic Nerve Sheath Diameter During Robot-Assisted Laparoscopic Prostatectomy
Official title: Effects of Positive End-Expiratory Pressure Ventilation on Optic Nerve Sheath Diameter in Patients Undergoing Robot-Assisted Laparoscopic Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Other Surgical Procedures
Keywords: Positive end-expiratory pressure ventilation
Optic nerve sheath diameter
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 38
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators aim to investigate the effects of positive end-expiratory pressure ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.

Detailed description: Effects of positive end-expiratory pressure ventilation on intracranial pressure have not been evaluated in patients undergoing laparoscopic surgery. We aim to investigate the effects of positive end-expiratory pressure ventilation on intracranial pressure assessed by sonographic optic nerve sheath diameter in patients undergoing robot-assisted laparoscopic prostatectomy.

Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled to undergo robot-assisted laparoscopic prostatectomy

Exclusion Criteria:

* Patients who have cerebrovascular disease or history of cerebrovascular disease
* Patients who are younger than 20 years

Primary outcomes:
measure: Optic nerve sheath diameter
timeFrame: intraoperative
Secondary outcomes:
measure: Peak airway pressure
timeFrame: intraoperative
measure: Arterial blood pressure
timeFrame: intraoperative
measure: Heart rate
timeFrame: intraoperative
measure: Arterial carbon dioxide tension
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
affiliation: Asan Medical Center
name: Young-Kug Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chin JH, Kim WJ, Lee J, Han YA, Lim J, Hwang JH, Cho SS, Kim YK. Effect of Positive End-Expiratory Pressure on the Sonographic Optic Nerve Sheath Diameter as a Surrogate for Intracranial Pressure during Robot-Assisted Laparoscopic Prostatectomy: A Randomized Controlled Trial. PLoS One. 2017 Jan 20;12(1):e0170369. doi: 10.1371/journal.pone.0170369. eCollection 2017.
Clinical trial NCT06679166: Fall Frequency in Children With Cerebral Palsy
Official title: Evaluation of Fall Frequency in Children With Cerebral Palsy: A Controlled Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cerebral Palsy
Lead sponsor: Beylikduzu State Hospital
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 46
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Cerebral palsy and healthy volunteers

Brief summary: The aim of this cross-sectional clinical study is to evaluate the frequency of falls in children diagnosed with cerebral palsy and compare it with healthy controls.

Detailed description: Our study is designed as a cross-sectional controlled study. A total of 23 children aged 5-12 years diagnosed with cerebral palsy, who can ambulate indoors or in the community either independently or with assistive devices, and 23 healthy children of the same age range will be included. Data will be collected on the age of the patients and healthy volunteers, information about their caregivers, frequency of falls, location and time of falls, education level, type of mobilization, presence of additional conditions, whether they receive rehabilitation, frequency of rehabilitation, duration of hospitalization if applicable, occurrence of falls during hospitalization, and presence of injuries. The collected data will be compared with the healthy controls.

Eligibility criteria: Inclusion Criteria:

* Children aged 5-12 years.
* Diagnosed with cerebral palsy (study group) or healthy without cerebral palsy (control group).
* Ability to ambulate either independently or with assistance indoors or in the community.
* Consent obtained from the participant or their caregiver (parent or guardian).

Exclusion Criteria:

* Refusal to participate in the study.
* Presence of cognitive impairments.
* Existence of neuromuscular diseases, other than cerebral palsy, that would impair walking ability or increase fall frequency.

Primary outcomes:
measure: Presence of falls
timeFrame: 0 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beylikdüzü State Hospital
Study officials:
References:
Clinical trial NCT00345566: Effect of Protein Composition on Gastric Emptying
Official title: Effect of the Protein Composition on the Gastric Emptying Rate in Children With Cerebral Paresis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Gastric Dysmotility
Enteral Feeding
Keywords: cerebral palsy
protein composition
gastric emptying rate
tube feeding
Lead sponsor: Ullevaal University Hospital
Sponsor class: OTHER
Collaborators: name: Numico Europe
First posted: 2006-06-28
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The protein composition of nutrition may affect the rate of gastric emptying and gastric fysiology. This is espesially important in children with neurologic impariment, who commonly rely on tube feedings, have feeding problems, nausea, vomiting, gastroesophageal reflux and delayed gastric emptying. We aim to find out whether 4 different protein sources affect the rate of gastric emptying and electrofysiology in this group of children.

Detailed description: Several factors in nutrition are known to affect gastric emptying rate, such as energy content, temperature, viscosity etc. In infants the protein composition affects gastric emptying. Children with cerebral pasly commonly have foregut dysmotility - with nausea, vomiting, feeding intolerance and gastroesophageal reflux. Tube feedings, usually based on cows milk are commonly used.

Our hypothesis is that the source and thus protein composition of feeding affects gastric emptying rate and electrofysiology.

Using four different tube feedings, standardized for content of fat, glucose and calories, we will measure gastric emptying rate using C13 octanoic acid as well as electrogastrography will be recorded. The protein modules are derived from casein, whey/casein mixture, hydrolyzed whey and aminoacids. Children with cerebral paresis and gastrostomy will be included. Each serves as his / her own control.

The primary endpoint is gastric emptying rate, the secondary endpoint electrogastrography.

Eligibility criteria: Inclusion Criteria: Cerebral paresis, user of tube feedings through gastrostomy -

Exclusion Criteria: Use of valproic acid (interferes with breath test). Age \>16 y.

-

Primary outcomes:
measure: Gastric emptying, measured by octanoic acid breath test.
Secondary outcomes:
measure: Electrogastrography
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ullevaal university hospital
Study officials:
name: Ketil Stordal, PHD
role: STUDY_CHAIR
References:
citation: Brun AC, Stordal K, Johannesdottir GB, Fossum V, Bentsen BS, Medhus AW. Nissen fundoplication in children with cerebral palsy: influence on rate of gastric emptying and postprandial symptoms in relation to protein source in caloric liquid meals. Clin Nutr. 2013 Aug;32(4):619-23. doi: 10.1016/j.clnu.2012.11.010. Epub 2012 Nov 17.
Clinical trial NCT01473966: Coffee Against Obstipation in Intensive Care Treatment
Official title: Coffee Against Obstipation in Intensive Care Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstipation
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
First posted: 2011-11-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Coffee might stimulate bowel movement and thus overcome obstipation in intensive care unit (ICU) patients.

Detailed description: Critically ill patients requiring ventilator support frequently suffer from obstipation. We hypothesize that coffee, administered either orally or rectally, might stimulate bowel movement.

Eligibility criteria: Inclusion Criteria:

* admission to the medical intensive care unit of the Dept. of Gastroenterology at the university hospital heidelberg
* requires ventilator support for an anticipated more than 72 hours
* age older than 18 years

Exclusion Criteria:

* pregnancy
* known allergy to coffee
* mechanical ileus
* presence of enterostoma

Primary outcomes:
measure: Bowel movement rate
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Secondary outcomes:
measure: time on mechanical ventilation
timeFrame: participants will be followed for the duration of intensive care unit stay, an expected average of 3 weeks
measure: time of stay on ICU
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
measure: lengths of hospitalisation
timeFrame: an average of 5 weeks of hospital stay is expected
measure: in hospital mortality
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
measure: long term mortality
timeFrame: 6 months following discharge
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University hospital of Heidelberg
Study officials:
affiliation: University of Heidelberg, Heidelberg, Germany
name: Christoph Eisenbach
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06755866: DCE-MRI Based on 4D Free Breathing for Predicting Preoperative Neoadjuvant Chemoradiotherapy for Esophageal Cancer
Official title: DCE-MRI Based on 4D Free Breathing for Predicting Preoperative Neoadjuvant Chemoradiotherapy for Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Lead sponsor: Yunnan Cancer Hospital
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To prospectively collect medical images and clinical data related to esophageal cancer using 4D Free Breathing DCE-MRI technology, to evaluate the image quality in the diagnosis of esophageal cancer, and to predict the efficacy of preoperative neoadjuvant chemoradiotherapy for esophageal cancer.


Eligibility criteria: Inclusion Criteria:

1. Be 18 years of age and older;
2. First diagnosis of esophageal squamous cell carcinoma confirmed by histopathological biopsy;
3. The clinical stage is cT1b\~cT2N+; or the clinical stage is cT3\~cT4 any N, (thoracic esophageal cancer, esophagogastric junction cancer);
4. There are no contraindications to MRI examination

Exclusion Criteria:

1. Have other primary tumors;
2. The image quality does not meet the diagnostic criteria;
3. Those who do not cooperate with the inspection;
4. Patients who have received prior chemoradiotherapy

Primary outcomes:
measure: Tumor response assessment
timeFrame: Surgery was performed within one month after neoadjuvant therapy, and the pathological pCR of the pathological results obtained from the surgery was used as the gold standard in this study to evaluate tumor treatment response
Secondary outcomes:
Other outcomes:
Locations:
city: Kunming City
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
Study officials:
affiliation: Ethics Committee of Yunnan Provincial Cancer Hospital
name: Lianhua Ye
role: STUDY_DIRECTOR
References:
Clinical trial NCT01247766: Safety Study of Abatacept to Treat Rheumatoid Arthritis
Official title: Post-marketing Observational Study Assessing the Long-term Safety of Abatacept Using a Population-based Cohort of Rheumatoid Arthritis Patients in the Province of British Columbia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Arthritis Research Centre of Canada
First posted: 2010-11-24
Enrollment: 6367
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: Residents of British Columbia who have received health care service for rheumatoid arthritis

Brief summary: The purpose of this study is to compare the incidence rates of infection, malignancy and death among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications for rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Rheumatoid arthritis
* Receipt of abatacept, other biologic disease-modifying drug, or any non- biologic disease-modifying anti-rheumatic drug
* Age 18 years or older

Exclusion Criteria:

* Below 18 years of age

Primary outcomes:
measure: Serious infection
timeFrame: Every 2 years throughout the study
measure: Incidence rates of malignancy
timeFrame: Every 2 years throughout the study
measure: Total mortality
timeFrame: Every 2 years throughout the study
Secondary outcomes:
measure: Multiple sclerosis
timeFrame: Every 2 years throughout the study
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT02266966: Effect of F2695 on Brain Activity Measured by Functional Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Subject
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2014-10-17
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this functional Magnetic Resonance Imaging (MRI) study is to assess the effect of single dose of F2695 at 75mg on modulation of the cerebral motor network.


Eligibility criteria: Inclusion Criteria:

Male right-handed\*, healthy volunteers 18 to 40 years of age. Having signed and dated an informed consent form

Exclusion Criteria:

Any significant disease or history of any clinically important drug allergy. Acute disease state within 7 days. History of drug abuse within 1 year. History or current excessive use of alcohol and / or positive alcohol screen. History of narrow angle glaucoma, seizures or epilepsy or brain injury. History of Gluten sensitivity, Gluten intolerance (celiac disease), Wheat allergy or Wheat intolerance.

History of obstructive voiding symptoms, including urinary retention.

Primary outcomes:
measure: Motor system cortical areas activation magnitude during a paced motor task.
timeFrame: 1 day (Period 1/Day +1, Period 2/Day +8)
Secondary outcomes:
measure: Incidence of adverse events (AEs) as a measure of safety and tolerability
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Centre d'Investigation Clinique (CIC)
Study officials:
affiliation: Hôpital Purpan CHU TOULOUSE, France
name: François Chollet
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04138966: Comparing Skin Conductance and Nol-index
Official title: Nociceptive Monitoring With Skin Conductance and Nol-index in Moderate-to-high Risk Cardiovascular Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Analgesia
Anesthesia
Monitoring
Vascular Diseases
Cardiac Disease
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac or vascular surgery

Brief summary: Comparison of twà different nociception monitors during general anesthesia

Detailed description: Analgesia remains a challenge in anesthesia. Several monitors have shown potential in detecting insufficient analgesia during general anesthesia, but they have not been investigated in patients undergoing cardiac and vascular surgery. In this study, we will compare skin conductance (Medstorm, Norway) and nol-index (Medasense, Israel) w during noxious and non-noxious stimuli. This study is carried out on patients included in another study (Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery).

Eligibility criteria: Inclusion Criteria:

* moderate-to-high risk cardiac or vascular surgery
* ASA 2-4

Exclusion Criteria:

* chronic arrhythmia (e.g. atrial fibrillation)
* aortic insufficiency
* pacemaker
* implanted defibrillator
* valve surgery

Primary outcomes:
measure: Nol-Index response
timeFrame: 1 to 2 hours
measure: Skin conductance response
timeFrame: 1 to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Anesthesia Department, Erasme Hospital
Study officials:
affiliation: Anesthesia Department, Erasme Hospital
name: Luc Barvais, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04541966: What Happens to First Trimester Nuchal Translucency
Official title: What Happens to First Trimester Nuchal Translucency Greater Than or Equal 99ème Percentile and Inferior 3.5 mm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nuchal Translucency
Keywords: Ultrasound abnormalities
Genetic abnormalities
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 230
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Single pregnancies with nuchal hyperclarity in the first trimester\> = 99th percentile at the Montpellier University Hospital with early pregnancy between January 2017 and December 2019.

Brief summary: First trimester nuchal translucency is a call point for genetic abnormalities and birth defects. Nuchal translucency varies with LCC and therefore with gestational age as described by Chung et al who created a 99th percentile curve of nuchal translucency versus LCC. The majority of centers use the 3.5 mm cutoff as the 99th percentile instead of using nuchal translucency based on LCC. The objective of this study is to compare the fate of nuchal hyperclites\> = 99th p but \<3.5mm versus 3.5mm. For this the investigators have studied the ultrasound and genetic abnormalities. The investigators were also interested in the pregnancy outcomes and the percentage of pregnancies in the group\> = 99th p and \<3.5mm that would have been sampled for a high combined risk for trisomy 21, and therefore to determine the benefit of a systematic sample. for HCN as well as the interest of performing an ACPA that would not be performed on a sample with a high risk of trisomy 21.


Eligibility criteria: Inclusion criteria:

nuchal translucency\> = 99th percentile

Exclusion criteria:

- multiple pregnancies

Primary outcomes:
measure: Pregnancies without ultrasound or genetic abnormalities
timeFrame: immediate antenatal and postnatal period
Secondary outcomes:
measure: ACPA interest
timeFrame: immediate antenatal and postnatal period
measure: percentage of samples for high risk combined for trisomy 21
timeFrame: immediate antenatal and postnatal period
measure: Pregnancy outcomes
timeFrame: immediate antenatal and postnatal period
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Florent FUCHS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01598766: General Investigative MRI Protocol
Official title: General Investigational Protocol for EXCELART VANTAGE ZGV/XGV/AGV/ ATLAS/XGV/ZGV TITAN/XGV VANTAGE TITAN 3T
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Multiple MRI Exams, Including
Cardiac
Abdominal
Lumbar
Neck
Pelvis
Lead sponsor: Toshiba America Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-15
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is a feasibility study to evaluate new technology to improve the MRI experience, with coils, sequences and software. Patients from the Principle Investigator's exam schedule are given the opportunity to participate in this study is their MRI exam is appropriate for the specific coil, sequence or software being evaluated. If they agree, they can receive their MRI exam with the new coil, sequence or software instead of the standard one.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients that are scheduled for a clinically necessary MRI exam provided the subject meets the criteria of the department MRI screening procedure and their study is appropriate for the use of the 4 Channel Flex SPEEDER coil of the 16 Channel Metaflex SPEEDER coil.

Exclusion Criteria:

* Any contraindication to MRI procedures

Primary outcomes:
measure: 16 Channel Flex Coil
timeFrame: May 2012-May 2013
Secondary outcomes:
measure: 8 Channel Value Breast Coil
timeFrame: 6 months
Other outcomes:
Locations:
city: Henderson
country: United States
facility: Steinberg Diagnostic Medical Imaging
state: Nevada
Study officials:
affiliation: Steinberg Diagnostic Medical Imaging
name: Mark L Winkler, MD
role: PRINCIPAL_INVESTIGATOR
References: