louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03220906: Comparison of Blood Pressure Measurements in Upper and Lower Extremities in Children Under General Anesthesia
Official title: Comparison of Blood Pressure Measurements in Upper and Lower Extremities in Children Under General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: King Fahad Medical City
First posted: 2017-07-18
Enrollment: 60
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing a surgical procedure with planned arterial cannula placement at Nationwide Children's Hospital in Columbus, OH or King Fahad Medical City in Riyadh, Saudi Arabia.

Brief summary: There is very little information comparing non-invasive blood pressure (BP) readings obtained from upper and lower limbs, as well as comparing invasive and non-invasive blood pressures in the children under anesthesia. This study seeks to determine the correlation between the non-invasive BP measurements between upper and lower extremities and compare these measurements with the invasive BP as the standard for comparison.


Eligibility criteria: Inclusion Criteria:

* ASA status 1-3
* 0-10 years of age
* Undergoing surgical procedure with planned arterial cannula placement

Exclusion Criteria:

* ASA status \>3
* Older than 10 years of age
* Patient unable to have BP taken on 1 upper and 1 lower extremity

Primary outcomes:
measure: Deviation >5 mmHg in MAP
timeFrame: 45 minutes
Secondary outcomes:
measure: Deviation >10 mmHg
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT02300506: Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma
Official title: Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Glioma
Keywords: Malignant Glioma
Glioblastoma multiforme
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-25
Enrollment: 507
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosed malignant glioma treated by surgery

Brief summary: The objective of this study is to determine the survival status of patients enrolled in study GLI01S (all-case observational study).


Eligibility criteria: Inclusion criteria:

* Malignant Glioma, patients enrolled in study GLI01S.

Exclusion criteria:

* Corresponding to contraindication of Gliadel.
* Not applicable to indications of Gliadel.

Primary outcomes:
measure: Survival rate
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
References:
citation: Iuchi T, Inoue A, Hirose Y, Morioka M, Horiguchi K, Natsume A, Arakawa Y, Iwasaki K, Fujiki M, Kumabe T, Sakata Y. Long-term effectiveness of Gliadel implant for malignant glioma and prognostic factors for survival: 3-year results of a postmarketing surveillance in Japan. Neurooncol Adv. 2022 Jan 12;4(1):vdab189. doi: 10.1093/noajnl/vdab189. eCollection 2022 Jan-Dec.
Clinical trial NCT01845506: The Application of a Wireless Sensor Technology for Vital Statistics in CHILDREN AND ADULTS
Official title: The Application of a Wireless Sensor Technology for Vital Statistics in CHILDREN AND ADULTS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fever
COPD
Obesity
Congenital Heart Disease
Respiratory Distress
Keywords: wireless pressure sensor
Elderly
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Lauren Faught
name: Michael Greff
name: Michael Rieder
name: Safieddin Safavi-Naeini
First posted: 2013-05-03
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The primary outcome for this project will be the development of a small, non-invasive wireless sensor that is linked to a conventional computer that can be used in health care for monitoring of acute and chronic health problems. The advantages of developing this technology are threefold. First, monitoring can be conducted for a fraction of the cost of a bedside nurse. Second, monitoring can be done in real time and stored so that we can diagnose and manage critical events in a more timely manner. Lastly, many patients can be monitored simultaneously. The wireless sensors will be fitted to healthy volunteers of various ages. The data gathered from the sensor with respect to their vital signs will be compared to that of conventional tools such as nursing assessments and pulse oximetry.


Eligibility criteria: Inclusion Criteria:

* Adults with controlled and non-controlled hypertension (hypertension defined as \> 130/90 on two separate occasions and history of hypertension)
* Adults with known chronic obstructive pulmonary disease in respiratory distress with oxygen saturations \< 90%
* Febrile adults (temp at triage \> 38 C) with no significant co-morbidities
* Elderly (\>70 years) patients with no significant co-morbidities
* Obese adults (BMI \> 30)
* Febrile (temp at triage \> 38 C) and non-febrile children (age \< 18 yrs)
* Obese children (BMI \> 30)
* Neonates (age \< 6 weeks)
* Children with corrected cyanotic congenital heart disease
* Children in respiratory distress that present with oxygen saturations \< 90%

Exclusion Criteria:

-Subjects with unstable vital signs will be excluded.

Primary outcomes:
measure: The primary outcome is the level of agreement between cardiorespiratory monitor and sensor information for heart rate.
timeFrame: 2 hours
measure: Level of agreement between cardiorespiratory monitor and sensor information for blood pressure
timeFrame: 2 hours
measure: Level of agreement between cardiorespiratory monitor and sensor information for temperature
timeFrame: 2 hours
measure: Level of agreement between cardiorespiratory monitor and sensor information for oxygen saturation
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: Children's Hospital London Health Sciences Center
state: Ontario
Study officials:
References:
Clinical trial NCT02677506: Infraclavicular or Supraclavicular Brachial Plexus Blocks for Elbow Surgery
Official title: A Randomized Comparison of Infraclavicular and Supraclavicular Brachial Plexus Blocks for Elbow Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cubital Tunnel Syndrome
Biceps Tendon Rupture
Keywords: elbow
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the infraclavicular approach to supraclavicular approach of brachial plexus block for elbow surgery.

Detailed description: Traditionally, infraclavicular as well as supraclavicular approaches to brachial plexus have been recommended for elbow surgery. Supraclavicular approach is considered to have a more rapid onset. However, investigators have noticed that the supraclavicular approach needs more supplementation if it is used for elbow surgery. Therefore more and more anesthesiologists now choose the infraclavicular approach for elbow surgery (though both approaches are recommended in the text books).

None of the published studies have addressed if one approach is indeed superior to the other specifically for elbow surgery. Therefore the investigators propose to undertake a study that will evaluate the two approaches to the brachial plexus specifically for elbow surgery.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for ambulatory elbow surgery under block
* ASA 1-3

Exclusion Criteria:

* Narcotic dependent
* Severe systemic illness
* Refusal of block
* localized infection

Primary outcomes:
measure: Time to completion of block
timeFrame: 30 minutes
Secondary outcomes:
measure: Readiness for surgery
timeFrame: 60 minutes
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Hospital
state: Ontario
Study officials:
affiliation: Western University
name: Shalini Dhir, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01584206: Sitosterolemia Metabolism
Official title: Assessment of Sterol Metabolism in Sitosterolemia: A Pilot Study of Patients Treated With Ezetimibe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sitosterolemia
Keywords: Sitosterolemia
Ezetimibe
Plant sterol
Cholesterol
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2012-04-24
Enrollment: 8
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Ezetimibe has become the treatment choice for patients with sitosterolemia. Ezetimibe is an inhibitor of cholesterol absorption from the gastrointestinal tract. The purpose of this study is to determine if ezetimibe improves whole body plant sterol and cholesterol homeostasis.


Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of homozygous sitosterolemia as established by genotyping and clinical parameters

Exclusion Criteria:

* pregnant
* intellectual disability
* major infectious diseases
* immunodeficiency
* cancer
* renal failure
* diabetes

Primary outcomes:
measure: Plasma cholesterol level
timeFrame: 8 months
measure: Plasma sitosterol level
timeFrame: 8 months
Secondary outcomes:
measure: Cholesterol absorption
timeFrame: 4 month
measure: Cholesterol synthesis
timeFrame: 4 months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Semone B Myrie, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manitoba
name: Peter J Jones, PhD
role: STUDY_CHAIR
References:
citation: Othman RA, Myrie SB, Mymin D, Roullet JB, DeBarber AE, Steiner RD, Jones PJH. Thyroid Hormone Status in Sitosterolemia Is Modified by Ezetimibe. J Pediatr. 2017 Sep;188:198-204.e1. doi: 10.1016/j.jpeds.2017.05.049. Epub 2017 Jun 16.
citation: Othman RA, Myrie SB, Mymin D, Merkens LS, Roullet JB, Steiner RD, Jones PJ. Ezetimibe reduces plant sterol accumulation and favorably increases platelet count in sitosterolemia. J Pediatr. 2015 Jan;166(1):125-31. doi: 10.1016/j.jpeds.2014.08.069. Epub 2014 Oct 16.
Clinical trial NCT06792006: Awareness of Climate Change Impacts Among University Students
Official title: Awareness Assessment of Climate Change Impacts Among a Group of University Students: a Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Climate Change
Keywords: climate change, College students, Awareness
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 273
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: University students from various years of study

Brief summary: This study evaluates college students' awareness of climate change and its effects on the environment through a questionnaire.


Eligibility criteria: Inclusion Criteria:

* All the university students are eligible to participate in the study

Exclusion Criteria:

-

Primary outcomes:
measure: Assessment of the climate change awareness among a group of university students
timeFrame: through study competition, average one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05326906: The Prediction Biomarkers of Survival Outcome for Severe Immune-related Hepatitis
Official title: The Prediction Biomarkers of Survival Outcome for Severe Immune-related Hepatitis in Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 20
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: Patients with immuntherapy underwent severe Immune-related Hepatitis

Brief summary: Immune checkpoint inhibitors have revolutionized lung cancer (LC) treatment, demonstrating a significant improvement in overall survival. However high-grade immune-related adverse events (irAEs) may result in harmful and serious clinical outcomes, even death. Immune-related hepatitis (IRH) is a potentially serious complication of checkpoint blockade, with an incidence of 5%-10% for ICIs monotherapy, including 1%-2% with grade 3 or higher. Therefore, it is particularly important to explore new and better prognostic and predictive biomarkers for IRH.


Eligibility criteria: Inclusion Criteria:

* The lung cancers were diagnosed by pathological evaluation.
* The PD-1/PD-L1 inhibitors were administered in all patients.
* Grade 3-5 immune-related hepatitis had occurred.
* The pre-treatment tissues or peripheral blood were available.

Exclusion Criteria:

* The pathological type was not lung cancers.
* Grade 1-2 immune-related hepatitis would be excluded.
* The any-grade hepatitis were induced by chemotherapy or virus.

Primary outcomes:
measure: Number of Participants with Immune-Related Hepatitis
timeFrame: 2 years
measure: Number of Participants Deaths
timeFrame: 2 years
Secondary outcomes:
measure: Number of Participants with Laboratory Abnormalities in Liver Tests
timeFrame: 2 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer hospital
state: Hunan
Study officials:
References:
Clinical trial NCT06099106: Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device
Official title: Evaluation of the Safety and Performance of ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Endomatic Ltd.
Sponsor class: INDUSTRY
First posted: 2023-10-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is designed to evaluate the safety and performance of the ENDOMATIC SEPIOLA Left Atrial Appendage (LAA) Closure Device in Patients with non-valvular Atrial Fibrillation, who are at increased risk for stroke, and that cannot take, or have a reason to seek an alternative, to long-term anticoagulation therapy.

Potential patients who are candidates for LAA closure will be screened to confirm that all inclusion/exclusion criteria are met, with final eligibility confirmation on day of procedure.

All enrolled subjects who went through the procedure will be followed during the procedure to hospital discharge.

Additional follow up time points are scheduled at 45 days, 6 months and 12 months post procedure.


Eligibility criteria: Inclusion Criteria:

* calculated CHA2DS2-VASc score of 2 or greater.
* The subject is non-eligible or have an appropriate rationale to seek a non-pharmacologic alternative to chronic oral anticoagulants.
* documented non-valvular atrial fibrillation
* Subject suitable for vascular/cardiac intervention procedure
* suitable LAA anatomical measurements for study device

Exclusion Criteria:

* Subject who requires anticoagulation for a condition other than AF.
* NYHA classification IV.
* Complex congenital heart disease.
* Presence of circumflex coronary artery stent.
* The subject has a prosthetic valve in any position.
* atrial septal defect closure or has an ASD/PFO device.
* presence of intracardiac thrombus.
* Any cardiac surgery in the past
* LVEF \< 35%.
* intracardiac thrombus
* moderate or severe mitral valve stenosis

Primary outcomes:
measure: SEPIOLA System Safety
timeFrame: 7 days, 45 days and 6 months post procedure
Secondary outcomes:
measure: Device success
timeFrame: 45 days
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Israeli-Georgian Medical Research Clinic Helsicore
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic
Study officials:
References:
Clinical trial NCT02718599: Effect of Terlipressin Infusion on Systemic and Hepatic Hemodynamics During Hepatobiliary Surgery
Official title: Effect of Terlipressin Infusion on Systemic and Hepatic Hemodynamics During Hepatobiliary Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hemodynamics, Liver, Terlipressin
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-03-24
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: To evaluate the effect of terlipressin infusion on systemic and hepatic hemodynamics during hepatobiliary surgery


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years.
* Any gender.
* ASA (American Society of Anesthesiologists) Classification( Class I-II)
* Patients undergoing major elective hepatobiliary surgery.

Exclusion Criteria:

* Preoperative renal failure (GFR \< 50 ml/min).
* Severe liver dysfunction (Child- turcotte -Pugh grade C).
* Hyponatremia (\<132 mmol/l).
* Severe aortic regurgitation, severe mitral regurgitation, heart failure.
* Symptomatic coronary heart disease.
* Bradycardic arrhythmia (heart rate \< 60/min).
* Peripheral artery occlusive disease (clinical stadium II-IV).
* Uncontrolled arterial hypertension (Blood pressure \>160/100 mmHg despite intensive treatment).
* Pregnancy.

Primary outcomes:
measure: portal pressure changes
timeFrame: intraoperative period
Secondary outcomes:
measure: Effect on systemic vascular resistance
timeFrame: intraoperative period
measure: Renal impairment
timeFrame: for 3 days in the postoperative period
measure: Blood units transfused
timeFrame: intraoperative period
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University hospital
state: Asyut Governorate
Study officials:
affiliation: Assiut University
name: Mostafa Samy
role: STUDY_DIRECTOR
References:
citation: Mahdy MM, Abbas MS, Kamel EZ, Mostafa MF, Herdan R, Hassan SA, Hassan R, Taha AM, Ibraheem TM, Fadel BA, Geddawy M, Sayed JA, Ibraheim OA. Effects of terlipressin infusion during hepatobiliary surgery on systemic and splanchnic haemodynamics, renal function and blood loss: a double-blind, randomized clinical trial. BMC Anesthesiol. 2019 Jun 15;19(1):106. doi: 10.1186/s12871-019-0779-6.
Clinical trial NCT05752513: Early vs Late Bladder Dissection During CS Hysterectomy in Patients With PAS With Bladder Invasion
Official title: Early vs Late Bladder Dissection During Cesarean Hysterectomy in Patients With Placenta Accreta Spectrum With Bladder Invasion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Placenta Accreta Spectrum
Cesarean Hysterectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Thirty-six singleton pregnant women with PAS and bladder invasion; total anterior or anterolateral invasion, who were scheduled for cesarean hysterectomy were randomly assigned into two equal groups

* Group 1: included 18 pregnant women scheduled for classical cesarean hysterectomy for placenta accreta with or without ligation of anterior division of internal iliac artery before cesarean section.
* Group 2: included 18 pregnant women scheduled for bladder last cesarean hysterectomy with or without ligation of anterior division of internal iliac artery.


Eligibility criteria: Inclusion Criteria:

1. Age: reproductive age.
2. Pregnant with singleton living fetus.
3. Previous one or more cesarean sections.
4. Gestational age: \> 34 weeks.
5. Elective or non-emergency cesarean sections.
6. Preoperative hemoglobin more than 9.5 gm/dl.

Exclusion Criteria:

Women with history of any medical disorder with pregnancy eg. gestational diabetes, hypertension, or anemia.

Primary outcomes:
measure: Amount of blood loss
timeFrame: during cesarean hysterectomy
Secondary outcomes:
measure: Operative time
timeFrame: during cesarean hysterectomy
measure: bladder injury
timeFrame: during cesarean hysterectomy
measure: ureteric injury
timeFrame: during cesarean hysterectomy
measure: Need for massive blood transfusion
timeFrame: during cesarean hysterectomy
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References: