louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04999007: Artificial Intelligence Assists Surgeons' Decision Making
Official title: Artificial Intelligence-assisted Decision Making for Temporary Ileostomy: A Prospective Randomized Controlled Trail.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Cancer
Keywords: artificial intelligence,
rectal cancer
temporary ileostomy
anastomotic leakage
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 616
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will evaluate whether artificial intelligence technique reduces the temporary ileostomy rate in patients with rectal cancer who receive anterior resection.

Detailed description: Anastomotic leakage is a serious and life-threatening complication after anterior resection in patients with rectal cancer, and temporary ileostomy was introduced to reduce the serious consequences due to anastomotic leakage. However, whether a temporary ileostomy is applied in the surgery depends on the surgeon's experience, and there are no clinical guidelines to follow. Recently, artificial intelligence has widely been applied in medical field and produced some exciting results, and we have developed a high-performance artificial intelligence model based on 2369 rectal cancer patients, which showed good discrimination of anastomotic leakage and may reduce the temporary ileostomy rate. Hence, this randomized controlled trail will evaluate the artificial intelligence model for guiding surgical decision-making of performing a temporary ileostomy in patients with rectal cancer who receive anterior resection.

Eligibility criteria: Inclusion Criteria:

1. Aged older than 18 years and younger than 85 years.
2. Primary rectal adenocarcinoma confirmed by preoperative pathology result.
3. Expected curative resection via total mesorectal excision procedure.
4. American Society of Anesthesiologists (ASA) class I, II, or III.
5. Written informed consent.

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Severe mental disorder or language communication disorder.
3. Hartmann surgery or colostomy is performed intraoperatively.
4. Interrupted of surgery for more than 30 minutes due to any cause.
5. Malignant tumors with other organs

Primary outcomes:
measure: The rate of temporary ileostomy.
timeFrame: Intraoperative period
measure: The morbidity of anastomotic leakage.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Huazhong University of Science and Technology
name: Jichao Qin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04290507: Epidemiology and Outcome of Anaphylactic Shocks Admitted to Intensive Care Unit
Official title: Epidemiology and Outcome of Anaphylactic Shocks Admitted to Intensive Care Unit: a French Retrospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anaphylaxis
Keywords: fluid management
mortality
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to ICU following anaphylaxis

Brief summary: Anaphylaxis is a severe life-threatening reaction following exposure to an antigen. Its incidence is progressively increasing in the general population over years, accompanied with an increased number of hospitalizations. Although rare, this condition is often associated with a significant morbidity and mortality. The mortality rate has been recently estimated at 0.84 (95% CI, 0.79 to 0.88) per million per year in the French adult population. Age, chronic medication and cardiac or pulmonary comorbidities have been reported to increase the risk of a severe reaction. Obesity, age and cardiovascular comorbidities have been identified as risk factors for fatal anaphylaxis. However, the risk factors for death after ICU admission have not been elucidated yet.


Eligibility criteria: Inclusion Criteria:

* Being \> 18 years old
* suffered an anaphylactic reaction, regardless of the location or causative allergen
* transferred alive in an ICU

Exclusion Criteria:

* dead within less than one hour after admission

Primary outcomes:
measure: In-ICU mortality
timeFrame: Day 30
Secondary outcomes:
measure: Volume of fluid administered
timeFrame: Day 30
measure: Amount of epinephrine
timeFrame: Day 30
measure: Amount of norepinephrine
timeFrame: Day 30
measure: Number and severity of organ failure
timeFrame: Day 30
measure: Extracorporeal life support requirement
timeFrame: Day 30
Other outcomes:
Locations:
city: Nancy
country: France
facility: University Hospital of Nancy
city: Strasbourg
country: France
facility: University Hospital of Strasbourg
Study officials:
References:
citation: Guerci P, Tacquard C, Chenard L, Millard D, Soufir L, Malinovsky JM, Garot M, Lalot JM, Besch G, Louis G, Thion LA, Charpentier C, Kimmoun A, Danguy Des Deserts M, Carreira S, Plantefeve G, Novy E, Abraham P, Mertes PM; Societe Francaise d'Anesthesie et Reanimation (SFAR) Research Network. Epidemiology and outcome of patients admitted to intensive care after anaphylaxis in France: a retrospective multicentre study. Br J Anaesth. 2020 Dec;125(6):1025-1033. doi: 10.1016/j.bja.2020.08.024. Epub 2020 Sep 12.
Clinical trial NCT00936507: Does Portion Size Influence Intake of Low-Energy-Dense Foods in Preschool-aged Children?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caloric Intake
Keywords: energy density
portion size
child feeding
Lead sponsor: The University of Tennessee, Knoxville
Sponsor class: OTHER
First posted: 2009-07-10
Enrollment: 17
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this randomized controlled study using a crossover design is to investigate the main effect of portion size and food type (low-energy dense vs. high-energy dense) on caloric intake.

Detailed description: The purpose of this investigation is to examine the impact of portion size on intake of a low energy dense food (fruit). Preschool-aged children will be provided with a small and large portion of applesauce (low-energy-dense food) and chocolate pudding (higher-energy-dense food) and allowed to eat the foods ad libitum during an afternoon snack in their usual preschool classroom. Measures of the amount of each food (grams and kilocalories) consumed will be taken.

The following hypotheses are proposed:

1. A significant main effect of portion size will occur, such that children will consume more food, both in grams and kilocalories, in the large portion as compared to the small portion conditions.
2. A main effect of food type on caloric intake will occur, such that children will consume less calories in the applesauce condition as compared to the pudding condition, due to the differences in energy density of these foods. It is not anticipated that a difference in grams consumed from each food will occur.

Eligibility criteria: Inclusion Criteria:

* All children that are ≥3 years of age enrolled in the ELC preschool with parental consent can participate.
* Eligible children must also like both the applesauce and the pudding, and be able to consume foods with a spoon.

Exclusion Criteria:

* Children allergic to applesauce or chocolate pudding or who are lactose- intolerant will not be included in the study.
* Did not attend all feeding sessions.
* Did not consume more than 5 grams from any of the foods on an occasion.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: Healthy Eating and Activity Laboratory, University of Tennessee
state: Tennessee
Study officials:
References:
Clinical trial NCT01041807: Cozaar XQ Re-examination Study (MK-0954-349)
Official title: Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of COZAAR XQ in Usual Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2010-01-01
Enrollment: 669
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with essential hypertension not adequately controlled with amlodipine or losartan monotherapy; initial therapy for participants with stage 2 hypertension

Brief summary: This survey is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Law and its Enforcement Regulation; its aim is to reconfirm the clinical usefulness of COZAAR XQ through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.


Eligibility criteria: Inclusion criteria:

* Participant with essential hypertension
* Participant who is treated with COZAAR XQ within local label for the first time

Exclusion criteria:

* Participant who is treated with COZAAR XQ before contract and out of enrollment period
* Participant who has a contraindication to COZAAR XQ according to the local label

Primary outcomes:
measure: Number of participants with any adverse experience
timeFrame: Up to 14 days after last treatment
measure: Change of sitting systolic and diastolic blood pressure (SiSBP, SiDBP) after treatment and overall efficacy evaluation by investigator
timeFrame: At 8 weeks after first treatment
Secondary outcomes:
measure: Change of sitting systolic and diastolic blood pressure (SiSBP, SiDBP) after treatment and overall efficacy evaluation by investigator
timeFrame: At 24 weeks after first treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04176107: The Effect of Exposure to Informative Video Before Cesarean Delivery on Maternal Anxiety
Official title: The Effect of Exposure to Informative Video Before Cesarean Delivery on Maternal Anxiety and Peripartum Satisfaction- a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Distress (During Labor)
Anxiety
Keywords: Cesarean delivery
Anxiety
Informative-video
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-11-25
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The incidence of cesarean deliveries (CD) worldwide is increasing, around 30% in United States. Although very common surgery women undergoing non emergent CD still experience fear and anxiety. It is known that increased levels of stress can negatively affect pain perception and the usage of analgesics postoperatively as well as lactation.

this present study investigate the effect of exposure to informative video before cesarean delivery on maternal anxiety.

Detailed description: A multi-center randomized control trial the will examine the effect of exposure to informative video before cesarean delivery on maternal anxiety and satisfaction

Eligibility criteria: Inclusion Criteria:

* Hebrew speaking
* Informed consent
* First cesarean delivery
* Non emergent elective CD

Exclusion Criteria:

* Non Hebrew speaking
* Refuse to participate
* Emergency CD

Primary outcomes:
measure: The State-Trait Anxiety Inventory STAI:Y-1
timeFrame: Baseline (Questionnaire filled by the patient Before operation)
Secondary outcomes:
measure: The State-Trait Anxiety Inventory STAI:Y-1
timeFrame: Questionnaire filled by the patient at admission- 1 day before operation
measure: Childbirth experience questionnaire (CEQ)
timeFrame: Questionnaire filled by the patient at 1 day after the delivery
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Haemek Medical Center
city: Asdod
country: Israel
facility: Asuta Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Holon
country: Israel
facility: Wolfson medical center
Study officials:
affiliation: Wolfson Medical Center
name: hadas miremberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miremberg H, Yirmiya K, Vinter D, Lauterbach R, Yefet E, Nassra R, Paz YG, Hagege R, Weiner E. An informative video before planned cesarean delivery and maternal anxiety-a multicenter randomized controlled trial. Am J Obstet Gynecol MFM. 2022 May;4(3):100604. doi: 10.1016/j.ajogmf.2022.100604. Epub 2022 Feb 28.
Clinical trial NCT07025707: Comparison of Two Different Methods for Calculating Intraocular Lens Tilt and Decentration
Official title: Agreement and Reproducibility of Intraocular Lens Tilt and Decentration Measurements: A Comparison Between CASIA2 and CILT
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intraocular Lens
Lead sponsor: St John of God Hospital, Vienna
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: planned cataract surgery

Brief summary: Agreement and Reproducibility of Intraocular Lens Tilt and Decentration Measurements: A Comparison between CASIA2 and CILT

Detailed description: This prospective observational study evaluates the agreement and reproducibility of intraocular lens (IOL) tilt and decentration measurements obtained from two different imaging modalities: the CASIA2 anterior segment swept-source optical coherence tomography (AS-SS-OCT) system and the Calculator for Intraocular Lens Tilt (CILT) software, based on standardized anterior segment image analysis.

Eligibility criteria: Inclusion Criteria:

* planned cataract surgery
* agreement to participation

Exclusion Criteria:

* Zonulolysis
* Strabismus
* Reduced Compliance
* Axial length \<20 or \>25 mm
* Keratokonus
* PEX

Primary outcomes:
measure: Intraocular Lens Tilt (CASIA2 and CILT)
timeFrame: Measured during the pre-surgery examination under normal pupil conditions and after pharmacologic dilation (45 minutes post-mydriatic instillation).
measure: Intraocular Decentration (CASIA2 and CILT)
timeFrame: Measured during the pre-surgery examination under normal pupil conditions and after pharmacologic dilation (45 minutes post-mydriatic instillation).
Secondary outcomes:
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Krankenhaus der Barmherzigen Brüder Wien
Study officials:
affiliation: Hospital St. John of God
name: Michael Amon, Prim. Univ. Prof. Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT05684107: Sciatic Nerve Block, Adductor Canal Block, or IPACK Block
Official title: Femoral Nerve Block Combined With Sciatic Nerve Block Adductor Canal Block Or (Interspace Between The Popliteal Artery And The Capsule Of The Posterior Knee) IPACK Block For Postoperative Analgesia After Major Knee Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Operative Pain
Keywords: IPACK , Sciatic nerve block , adductor canal block
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Comparison between local anesthetic infiltration between the popliteal artery and the capsule of the knee (IPACK) versus adductor canal block (ACB) or sciatic nerve block (anterior approach) in combination with femoral nerve block for postoperative analgesia in major knee surgeries.


Eligibility criteria: Inclusion Criteria:

* ASA I or II physical status
* undergoing elective major knee surgery

Exclusion Criteria:

* refusal of the patients to give informed consent,
* preexisting coagulation disorders,
* known allergies to aminoamide local anesthetics,
* local infection at the site of the block,
* morbid obesity,
* hepatic and renal diseases
* patients with psychological disorders

Primary outcomes:
measure: change of visual analogue scale
timeFrame: change from 0 level every 1 hour for 1st 6 hours,then every 4 hours for next 24 hours and on movement
Secondary outcomes:
measure: time for fisrt analgesic request
timeFrame: up to 48 hours
measure: total morphine consumption
timeFrame: up to 48 hours
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Faculty of Medicine, University Hospitals
state: Menoufia
Study officials:
References:
Clinical trial NCT02118207: Exercise and Repetitive Diving
Official title: The Impact of Predive Exercise on Repetitive SCUBA Diving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decompression Sickness
Endothelial Dysfunction
Neutrophil Activation
Venous Gas Emboli
Keywords: SCUBA diving
Exercise
Microparticles
Repetitive diving
Endothelial function
Lead sponsor: University Hospital of Split
Sponsor class: OTHER
Collaborators: name: University of Maryland
First posted: 2014-04-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: SCUBA diving frequently involves repetitive exposures over multiple days. The goal of this study was to see how exercise impacts microparticles (MPs), endothelial function, and venous gas emboli (VGE) over a series of dives.

16 divers in 2 groups each completed 6 dives. One group completed 3 control dives followed by 5 days rest then 3 dives preceded by exercise. The other group completed the opposite protocol. Flow-mediated dilation (FMD) data and blood for MP analysis was collected before and after each dive. VGE were monitored via transthoracic echocardiography 30, 60, and 90 min after surfacing. Exercise before diving consisted of 60 min running outdoors including 8x4 min intervals at 90% VO2max effort.


Eligibility criteria: Inclusion Criteria:

* Certified SCUBA diver
* Certified to dive by experienced Medical evaluator
* Must be able to run continuously for 45 min

Exclusion Criteria:

* Prior diagnosis of decompression sickness

Primary outcomes:
measure: Change in circulating microparticle counts
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Split
country: Croatia
facility: University of Split School of Medicine
Study officials:
affiliation: University of Split, School of Medicine
name: Zeljko Dujic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01659307: The Effect of Aspirin on REducing iNflammation in Human in Vivo Model of Acute Lung Injury
Official title: The Effect of Aspirin on REducing iNflammation in Human in Vivo Model of Acute Lung Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Lung Injury
Keywords: Acute Lung Injury
Acute Respiratory Distress Syndrome
Aspirin
Lead sponsor: Belfast Health and Social Care Trust
Sponsor class: OTHER
Collaborators: name: The Intensive Care Society United Kingdom
name: Northern Ireland Clinical Trials Unit
name: Queen's University, Belfast
First posted: 2012-08-07
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a double-blind, placebo-controled, randomized trial to investigate if aspirin pre-treatment has anti-inflammatory effects in a model of acute lung injury induced by inhaled endotoxin (LPS) in healthy human volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Age \< 18 years
* Pregnancy or breast feeding or woman of childbearing potential not using
* adequate contraception.
* Participation in a clinical trial of an investigational medicinal product within 30 days
* Consent declined Aspirin or non steroidal anti-inflammatory (NSAID) use in the past 4 weeks
* History of asthma
* Known aspirin or NSAID hypersensitivity
* History of peptic ulcer disease
* Platelet count \< 150 x 106/ml
* Aspirin resistance

Primary outcomes:
measure: Bronchoalveolar lavage IL-8 concentration
timeFrame: 6 hrs after LPS inhalation
Secondary outcomes:
measure: Alveolar inflammatory response biomarkers
timeFrame: 6 hrs after LPS inhalation
measure: Plasma inflammatory response biomarkers
timeFrame: 6 and 24 hrs after LPS inhalation
measure: Alveolar epithelial and endothelial function and injury biomarkers
timeFrame: 6 hrs after LPS inhalation
measure: Lipid inflammatory mediators
timeFrame: 6 and 24 hrs after LPS inhalation
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust
Study officials:
affiliation: Queens University, Belfast
name: Danny McAuley
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamid U, Krasnodembskaya A, Fitzgerald M, Shyamsundar M, Kissenpfennig A, Scott C, Lefrancais E, Looney MR, Verghis R, Scott J, Simpson AJ, McNamee J, McAuley DF, O'Kane CM. Aspirin reduces lipopolysaccharide-induced pulmonary inflammation in human models of ARDS. Thorax. 2017 Nov;72(11):971-980. doi: 10.1136/thoraxjnl-2016-208571. Epub 2017 Jan 12.
citation: Toner P, McAuley DF, Shyamsundar M. Aspirin as a potential treatment in sepsis or acute respiratory distress syndrome. Crit Care. 2015 Oct 23;19:374. doi: 10.1186/s13054-015-1091-6.
citation: Curley GF, McAuley DF. Stem cells for respiratory failure. Curr Opin Crit Care. 2015 Feb;21(1):42-9. doi: 10.1097/MCC.0000000000000171.