louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00994994: Tranexamic Acid in Pediatric Cardiac Surgery
Official title: Tranexamic Acid Reduces Blood Loss in Pediatric Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Loss
Congenital Heart Disease
Keywords: pediatric cardiac surgery
bleeding
tranexamic acid
fibrinolysis
blood loss in pediatric cardiac surgery
Lead sponsor: Okayama University
Sponsor class: OTHER
First posted: 2009-10-14
Enrollment: 160
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tranexamic acid(TXA) is an antifibrinolytic agent to reduce blood loss in cardiac surgery. Previous seven RCTs comparing effects of TXA in pediatric cardiac surgery showed conflict results. The reason why they showed mixed results would be the imbalance of patients population with regard to presence of cyanosis. TXA would reduce blood loss in pediatric cardiac surgery with well balanced patients population.


Eligibility criteria: Inclusion Criteria:

* children undergoing elective cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* neonate born within 1 month
* preoperative inotropes
* preoperative mechanical ventilation
* preexisting coagulation disorder
* reoperation within 48 hours
* significant liver or kidney disease
* known allergy to TXA

Primary outcomes:
measure: the amount of blood loss (mediastinal and pericardial tube drainage) 24 hours after surgery
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: blood loss 6 hours after surgery
timeFrame: 6 hours after surgery
measure: the amount of blood transfusion
timeFrame: 24 hour after surgery
measure: additional TXA administration
timeFrame: 24 hours after surgery
measure: chest closure time (protamine to skin closure)
timeFrame: at the end of surgery
measure: re-exploration of chest for excess bleeding
timeFrame: within 24 hours after surgery
measure: duration of mechanical ventilation
timeFrame: at the time of extubation
measure: length of stay in intensive care unit
timeFrame: at the time of discharge from ICU
measure: episode of thrombotic complication
timeFrame: from drug administration to hospital discharge
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology and Intensive Care, Okayama University Hospital
name: Yuichiro Toda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shimizu K, Toda Y, Iwasaki T, Takeuchi M, Morimatsu H, Egi M, Suemori T, Suzuki S, Morita K, Sano S. Effect of tranexamic acid on blood loss in pediatric cardiac surgery: a randomized trial. J Anesth. 2011 Dec;25(6):823-30. doi: 10.1007/s00540-011-1235-z. Epub 2011 Sep 24.
Clinical trial NCT06688994: VITAMIN D METABOLITES AS BIOMARKERS FOR THE IDENTIFICATION OF KIDNEY INJURY IN CARDIAC SURGERY
Official title: Vitamin D Metabolites as Biomarkers for the Identification of Kidney Injury in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Kidney Injuries
Chronic Renal Diseases
Keywords: chronic renal disease, acute kidney injury, vitamin D
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: University of Toronto
First posted: 2024-11-14
Enrollment: 60
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: Patients undergoing cardiac surgery .

Brief summary: We will be measuring vitamin D metabolites in blood samples drawn from patients undergoing cardiac surgery to determine the correlation with renal function as assessed by serum creatinine. We will include 20 patients in each of the following 3 groups based on serum creatinine measured within 28-days of surgery: 1) normal kidney function (eGFR \> 60 mL/min, n=20), 2) moderate impaired kidney function, eGFR between 30 and 60 mL/min (n=20) and 3) severe kidney dysfunction eGFR \< 30 mL/min (n=20).


Eligibility criteria: Inclusion Criteria

* ≥ 18 years
* Patients undergoing cardiac surgery
* Serum Creatinine measured with 28 days of surgery

Exclusion Criteria

* Exogeneous calcitriol (1,25(OH)2D3) intake
* History of parathyroidectomy
* Patients with liver or kidney cancer
* Patients with liver disease (e.g. liver failure, cirrhosis)

Primary outcomes:
measure: Determine the correlation between eGFR as determined serum creatinine and vitamin D metabolites as markers of kidney function
timeFrame: Up to 1 month before surgery up until POD 7
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network-Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Stuart A McCluskey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chow EC, Quach HP, Vieth R, Pang KS. Temporal changes in tissue 1alpha,25-dihydroxyvitamin D3, vitamin D receptor target genes, and calcium and PTH levels after 1,25(OH)2D3 treatment in mice. Am J Physiol Endocrinol Metab. 2013 May 1;304(9):E977-89. doi: 10.1152/ajpendo.00489.2012. Epub 2013 Mar 12.
citation: Chow EC, Sondervan M, Jin C, Groothuis GM, Pang KS. Comparative effects of doxercalciferol (1alpha-hydroxyvitamin D(2)) versus calcitriol (1alpha,25-dihydroxyvitamin D(3)) on the expression of transporters and enzymes in the rat in vivo. J Pharm Sci. 2011 Apr;100(4):1594-604. doi: 10.1002/jps.22366. Epub 2010 Oct 21.
Clinical trial NCT01633294: Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term
Official title: Antibiotic Prophylaxis in Prelabor Rupture of Membranes at Term - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chorioamnionitis
Puerperal Endometritis
Neonatal Early Onset Sepsis
Neonatal Meningitis
Neonatal Pneumonia
Keywords: premature rupture of membranes
term pregnancy
chorioamnionitis
endometritis
neonatal sepsis
antibiotic prophylaxis
Lead sponsor: Hospital de Santa Maria, Portugal
Sponsor class: OTHER
First posted: 2012-07-04
Enrollment: 161
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aims of this study are to determine whether antibiotics administered routinely in women presenting with premature rupture of membranes later than the 37+0 weeks of gestation can alter the rate of maternal and neonatal infection and to compare these rates between prompt (\< 12 hour) and delayed (≥ 12 hour) induction in the group of patients not submitted to antibiotic prophylaxis.


Eligibility criteria: Inclusion Criteria:

* term (≥ 37+0 weeks) singleton pregnancy
* a vertex presentation
* ruptured membranes for less than 12 hours
* negative Group B Streptococcus (GBS) culture performed between 35 and 37 weeks

Exclusion Criteria:

* active labor
* absence of GBS culture or indication for GBS antibiotic prophylaxis (such as maternal GBS colonization between 35 and 37 weeks, GBS bacteriuria, prior infant with GBS sepsis)
* contraindication to expectant management (such as fetal distress, meconium staining of the amniotic fluid or chorioamnionitis) or to vaginal delivery

Primary outcomes:
measure: neonatal infection rate
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 days
measure: maternal infection rate
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 days
Secondary outcomes:
measure: comparison of the infection rates between prompt and delayed induction
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 3 days
Other outcomes:
Locations:
city: Lisboa
country: Portugal
facility: Hospital Santa Maria
Study officials:
affiliation: Santa Maria Hospital
name: Filipa Faria Vaz Passos, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Passos F, Cardoso K, Coelho AM, Graca A, Clode N, Mendes da Graca L. Antibiotic prophylaxis in premature rupture of membranes at term: a randomized controlled trial. Obstet Gynecol. 2012 Nov;120(5):1045-51. doi: 10.1097/aog.0b013e31826e46bc.
Clinical trial NCT03431194: Midodrine is Effective in Management of Intradialytic Hypotension Among Critically-ill Patients With Acute Kidney Injury
Official title: Midodrine is Effective in Management of Intradialytic Hypotension Among Critically-ill Patients With Acute Kidney Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: Acute Kidney Injury
midodrine
intensive care unit
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: New Jeddah Clinic Hospital
First posted: 2018-02-13
Enrollment: 80
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: The aim of this randomized trial was to assess the efficacy of oral midodrine tablets for the management of intradialytic hypotension among critically ill patients with acute kidney injury.

Detailed description: In This open -label study, patients in ICU with acute kidney injury are randomized to either midodrine tablets or placebo. the number of intradialytic episodes and both systolic and diastolic blood pressure between both groups are compared. Mortality and adverse effects are monitored and compared as well.

Eligibility criteria: Inclusion Criteria:

* ICU patients
* acute kidney injury
* age above 18 years
* documented hypotension during dialysis

Exclusion Criteria:

* packed red blood cells transfusion
* intravenous inotropes
* alteration of blood pressure medications

Primary outcomes:
measure: Number of hypotensive episodes
timeFrame: 30 days from start of hemodialysis
Secondary outcomes:
measure: mean systolic blood pressure
timeFrame: 30 days from start of hemodialysis
measure: mean diastolic blood pressure
timeFrame: 30 days from start of hemodialysis
measure: Mortality in each arm
timeFrame: 30 days from start of hemodialysis
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00006194: Effects of Exercise on Markers of Inflammation in Skeletal Muscle in Elderly Hip Fracture Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Muscular Atrophy
Keywords: sarcopenia
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-09-08
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Decreased skeletal muscle mass is a prevalent condition among the elderly, and an important cause of disability and functional decline. The declines in muscle mass associated with aging may be related to alterations in specific kinds of growth factors in the muscle. Elderly hip fracture patients often have significant decreases in muscle mass. The purpose of this study is to investigate whether an exercise program can induce changes in muscle growth factors that are associated with increases in muscle mass and strength in elderly hip fracture patients.


Eligibility criteria: Inclusion Criteria:

* Enrollment in HSC protocol #97-0695 "Rehabilitation Intensification Post Hip Fracture"
* Community-dwelling
* Hip fracture within 16 weeks of the screening assessment for protocol 97-0695
* Persistent mobility and/or ADL impairments, but independent in ambulation
* Modified Physical Performance Test (PPT) score between 12 and 28

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
References:
citation: Fairhall NJ, Dyer SM, Mak JC, Diong J, Kwok WS, Sherrington C. Interventions for improving mobility after hip fracture surgery in adults. Cochrane Database Syst Rev. 2022 Sep 7;9(9):CD001704. doi: 10.1002/14651858.CD001704.pub5.
Clinical trial NCT05005494: Hypnotic and Anti-nociceptive Components of Magnesium
Official title: Study of the Hypnotic and Anti-nociceptive Components of Magnesium Using Electroencephalogram Spectral Entropy and Pupillometry During Total Intravenous General Anaesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded prospective randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of our study is to evaluate the effect of magnesium on the hypnotic effect of propofol.

Detailed description: The aim of our study is to evaluate the effect of magnesium on the hypnotic effect of propofol. To achieve this, the investigators will analyse the effect of magnesium on the brain concentrations of propofol required to achieve a State Entropy value between 50-60, which corresponds to the recommended depth of anaesthesia. Our study will also evaluate the intraoperative anti- nociceptive effect of magnesium using pupillometry and its two indices, PPI and PRD

Eligibility criteria: Inclusion Criteria:

* Adult \> 18 years
* Patients of both sexes
* Any patient scheduled for thyroidectomy at the University Hospital of Liege

Exclusion Criteria:

* Heart failure with left ventricular ejection fraction \< 35
* Renal insufficiency (clearance \< 40 mL/min)
* Neuromuscular diseases
* Atrioventricular block
* Pregnancy

Primary outcomes:
measure: Propofol target concentration
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: Morphine consumption
timeFrame: through study completion, an average of 3 months
measure: PPI Measure
timeFrame: through study completion, an average of 3 months
measure: PRD Measure
timeFrame: through study completion, an average of 3 months
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU Liege,
Study officials:
References:
Clinical trial NCT03839394: Case Managers for CVD Risk Reduction in HIV Clinic
Official title: A Clinic-Based Case Manager Administered Telephone Intervention to Reduce Cardiovascular Disease Risk in Persons Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
HIV
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-02-15
Enrollment: 50
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: OTHER

Brief summary: The purpose of the study is to assess the efficacy of a case manager/social worker administered, telephone-based educational curriculum in improving cardiovascular disease related outcomes among HIV-infected clinic patients.

Detailed description: Fifty high Cardiovascular Disease Risk (CVD) risk clinic patients will be randomized 1:1 to receive either a series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum delivered over 24 weeks \[intervention arm\], or the educational pamphlets alone \[control arm\]. Anthropomorphic data, blood pressure and lipid profiles will be obtained from patients to assess the efficacy of the intervention in reducing blood pressure and serum low-density lipoprotein levels (LDL).

Eligibility criteria: Inclusion Criteria:

* In care at the Duke Infectious Diseases Clinic for HIV and for at least 24 months
* On antiretroviral therapy
* 2013 American Heart Association 10-year ASCVD risk score ≥ 15%, with a diagnosis of either hypertension or hyperlipidemia
* English literate (able to speak and read at a 6th grade level)
* Subjects must have the capacity to give legally effective consent.

Exclusion Criteria:

* Patients with prior diagnosis of acute coronary syndrome, stroke, peripheral vascular disease, and end stage renal disease

Primary outcomes:
measure: Change in Ambulatory Systolic Blood Pressure
timeFrame: Baseline, 24 weeks, 48 weeks, 72 weeks
measure: Number of Participants Who Achieve >5mmHg Reduction in Systolic Blood Pressure From Baseline
timeFrame: Baseline, 72 weeks
measure: Change in Non-HDL (High Density Lipoprotein Cholesterol) Levels
timeFrame: Baseline, 24 weeks, 48 weeks, 72 weeks
Secondary outcomes:
measure: Total Change in Body Weight
timeFrame: Baseline, 24 weeks, 48 weeks, 72 weeks
measure: Change in 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Score
timeFrame: Baseline, 24 weeks, 48 weeks, 72 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Nwora L Okeke, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02141594: Posterior Pole Asymmetry Analysis (PPAA) for Early Glaucoma
Official title: Diagnostic Ability of Posterior Pole Asymmetry Analysis Parameters (PPAA) of Spectralis Optical Coherence Tomography (OCT) in Detecting Early Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Lead sponsor: Dr T V Patel Eye Institute
Sponsor class: OTHER
First posted: 2014-05-19
Enrollment: 156
Sex: ALL
Minimum age (years): 49
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive 80 eyes of 80 normal subjects and 76 eyes of 76 patients with early glaucoma were included for the study.

Brief summary: Spectrailis optical coherence tomography has come with a new posterior pole asymmetry analysis for glaucoma diagnosis. The aim of the investigators study was to assess its applicability in diagnosing early glaucoma patients.


Eligibility criteria: Inclusion Criteria:

* Age more than 18 years
* Best corrected visual acuity 20/40 or better
* Refractive error within ±5D sphere and ±3D cylinder
* Willingness to participate in the study

Exclusion Criteria:

* Media opacities preventing imaging
* Intraocular surgery within the last 6 months
* Any retinal or neurological disease other than glaucoma that could confound the results of visual field examination and OCT.

Primary outcomes:
measure: Area under curve for all the diagnostic parameters of optical coherence tomography
timeFrame: up to 32 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vadodara
country: India
facility: Dr TV Patel Eye Institute
state: Gujarat
Study officials:
affiliation: Dr TV Patel Eye Institute
name: Paaraj R Dave, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mori S, Hangai M, Sakamoto A, Yoshimura N. Spectral-domain optical coherence tomography measurement of macular volume for diagnosing glaucoma. J Glaucoma. 2010 Oct-Nov;19(8):528-34. doi: 10.1097/IJG.0b013e3181ca7acf.
citation: Nakatani Y, Higashide T, Ohkubo S, Takeda H, Sugiyama K. Evaluation of macular thickness and peripapillary retinal nerve fiber layer thickness for detection of early glaucoma using spectral domain optical coherence tomography. J Glaucoma. 2011 Apr-May;20(4):252-9. doi: 10.1097/IJG.0b013e3181e079ed.
citation: Seong M, Sung KR, Choi EH, Kang SY, Cho JW, Um TW, Kim YJ, Park SB, Hong HE, Kook MS. Macular and peripapillary retinal nerve fiber layer measurements by spectral domain optical coherence tomography in normal-tension glaucoma. Invest Ophthalmol Vis Sci. 2010 Mar;51(3):1446-52. doi: 10.1167/iovs.09-4258. Epub 2009 Oct 15.
citation: Rao HL, Babu JG, Addepalli UK, Senthil S, Garudadri CS. Retinal nerve fiber layer and macular inner retina measurements by spectral domain optical coherence tomograph in Indian eyes with early glaucoma. Eye (Lond). 2012 Jan;26(1):133-9. doi: 10.1038/eye.2011.277. Epub 2011 Nov 11.
Clinical trial NCT06739694: Neuroscience Education in Shoulder Pain: Clinical Trial
Official title: The Efficacy of a Pain Neuroscience Education Programme in Shoulder Pain: a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Keywords: exercise
manual therapy
shoulder pain
pain neuroscience education
Lead sponsor: Universidad de León
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objectives: The purpose of this study was to assess the efficacy of a pain neuroscience education programme applied to patients with shoulder pain.

Detailed description: A randomised controlled trial was performed. Fifty-five patients satisfied eligibility criteria, agreed to participate, and were randomized into an experimental group (n = 27) or control group (n =28). A manual therapy and exercises program was administered for both groups. In addition, a pain neuroscience education protocol was administered for the experimental group for a whole period of 4 weeks (1 session/week, 75mins per session).

Eligibility criteria: Inclusion Criteria:

* Being 18-70 years of age.
* History of shoulder pain of more than 3 months duration.
* Presence of a painful arc
* Medical diagnosis of shoulder pain with at least 2 positive impingement tests including Neer, Hawkins, or Jobe test

Exclusion Criteria:

* Diagnosis of fibromyalgia.
* Pregnancy.
* A history of traumatic onset of shoulder pain.
* Other histories of shoulder injury.
* Torn tendons.
* Ligamentous laxity based on a positive Sulcus and apprehension tests.
* Numbness or tingling in the upper extremity.
* Previous shoulder or cervical spine surgery.
* Systemic illness.
* Corticosteroid injection on the shoulder within 1 year of the study.
* Physical therapy 6 months before the study.

Primary outcomes:
measure: Pain
timeFrame: Baseline and 5 weeks.
measure: Disability
timeFrame: Baseline and five weeks.
Secondary outcomes:
measure: kinesiophobia
timeFrame: Baseline and 5 weeks.
Other outcomes:
measure: catastrophizing
timeFrame: Baseline and 5 weeks.
Locations:
city: León
country: Spain
facility: Eva
Study officials:
affiliation: Universidad de León
name: Eva Prado Robles
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wood L, Hendrick PA. A systematic review and meta-analysis of pain neuroscience education for chronic low back pain: Short-and long-term outcomes of pain and disability. Eur J Pain. 2019 Feb;23(2):234-249. doi: 10.1002/ejp.1314. Epub 2018 Oct 14.