louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03792334: Comparison of BIS and PIS in Children
Official title: A Comparison Between Patient State Index (PSI) and Bispectral Index (BIS) as Technologies for Monitor in Depth of Anesthesia in Children: A Prospective Observational Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depth of Anesthesia Monitor
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: general anesthesia

Brief summary: Comparison of bispectral index and patient sedation index during general anesthesia in children

Detailed description: the values of BIS and PSI of every 1 minute during general anesthesia in children

Eligibility criteria: Inclusion Criteria:

* general anesthesia

Exclusion Criteria:

* developmental delay
* IICP

Primary outcomes:
measure: correlation of BIS and PSI
timeFrame: through study completion, an average of 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUH
state: Jongnogu
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hee-Soo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jang YE, Kim EH, Lee JH, Kim JT, Kim HS. Usefulness of bispectral index and patient state index during sevoflurane anesthesia in children: A prospective observational study. Medicine (Baltimore). 2022 Jul 29;101(30):e29925. doi: 10.1097/MD.0000000000029925.
Clinical trial NCT04365634: A Single-center Retrospective Study to Find Prediction Factors Related to Mortality of COVID-19 Patients.
Official title: A Single-center Retrospective Study to Find Prediction Factors Related to Mortality of COVID-19 Patients by Univariate and Multivariate Analysis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 306
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients admitted from Feb 2, 2020 to Feb 15, 2020, diagnosed with SARS-CoV-2 pneumonia according to interim guidance of National health commission of the people's republic of China were enrolled. Laboratory confirmed cases were identified with positive viral RNA by real-time RT-PCR detection by the local health authority or our hospital from specimen taken from throat or nasal swab.

Brief summary: In the single-centered, retrospective study, 306 hospital patients (including 129 diabetes and 177 non-diabetes patients) confirmed with SARS-CoV-2 infection were enrolled in Tongji Hospital, Wuhan, China. Clinical characteristics including clinical manifestation, laboratory parameters, lung CT features and clinical outcomes were compared between diabetes and non-diabetes patients. The prediction factors were analyzed for mortality of COVID-19 by univariate and multivariate analysis.


Eligibility criteria: Inclusion Criteria:

Patients admitted from Feb 2, 2020 to Feb 15, 2020, diagnosed with SARS-CoV-2 pneumonia according to interim guidance of National health commission of the people's republic of China.

Exclusion Criteria:

With SARS-CoV-2 RNA detection negative results.

Primary outcomes:
measure: Find the prediction factors associated with hospitalized death of patients with COVID-19 by univariate and multivariate analysis
timeFrame: 28 days
Secondary outcomes:
measure: Demographics and clinical characteristics
timeFrame: 28 days
measure: Laboratory parameters and radiography image features
timeFrame: 28 days
measure: Treatment, complications and clinical outcomes
timeFrame: 28 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Meifang Han, Professor
role: STUDY_CHAIR
References:
citation: Han M, Ma K, Wang X, Yan W, Wang H, You J, Wang Q, Chen H, Guo W, Chen T, Ning Q, Luo X. Immunological Characteristics in Type 2 Diabetes Mellitus Among COVID-19 Patients. Front Endocrinol (Lausanne). 2021 Mar 11;12:596518. doi: 10.3389/fendo.2021.596518. eCollection 2021.
Clinical trial NCT01750034: Best Method of Burn Wound Care: A Prospective Randomized Trial
Official title: Best Method of Burn Wound Care: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Burns
Keywords: Burns
Wounds and injuries
Bandages
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to better understand how to best care for burn wounds.

Detailed description: Participants: Patients presenting to Kamuzu Central Hospital in Lilongwe Malawi with burn wounds occuring within 72 hours of admission.

Procedures (methods): This is a prospective randomized trial. Subjects will be randomized during admission to receive either open dressing care or closed dressing care of their burn wounds.

Eligibility criteria: Inclusion Criteria:

* Burn wound admitted to the hospital
* Signed informed consent
* Burn wound occuring within 72 hours of admission

Exclusion Criteria:

* Language other than Chichewa or English
* Inability to access of phone (required for follow-up)

Primary outcomes:
measure: Time to healing
timeFrame: 30-day
Secondary outcomes:
measure: Mortality
timeFrame: 30-day
measure: Burn wound infection rate
timeFrame: 30-day
Other outcomes:
measure: Microbiologic profile of clinical infections
timeFrame: 30-day
measure: Number of surgical procedures
timeFrame: 30-day
measure: percent skin graft survival
timeFrame: 30-day
measure: Hospital length of stay
timeFrame: 30-day
Locations:
Study officials:
affiliation: UNC Chapel Hill Department of Surgery
name: Jared Gallaher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gosselin RA, Kuppers B. Open versus closed management of burn wounds in a low-income developing country. Burns. 2008 Aug;34(5):644-7. doi: 10.1016/j.burns.2007.09.013. Epub 2008 Jan 15.
citation: Dominguez O, Bains JW, Lynch JB, Lewis SR. Treatment of burns with silver nitrate versus exposure method: analysis of 200 patients. Plast Reconstr Surg. 1967 Nov;40(5):489-93. doi: 10.1097/00006534-196711000-00012. No abstract available.
citation: HOLMAN SP, SHAYA ES, HOFFMEISTER FS, EDGERTON MT Jr. Studies on burns. I. The exposure method vs. occlusive dressings in the local treatment of experimental burns. Ann Surg. 1956 Jan;143(1):49-56. doi: 10.1097/00000658-195601000-00006. No abstract available.
citation: Kiser MM, Samuel JC, Mclean SE, Muyco AP, Cairns BA, Charles AG. Epidemiology of pediatric injury in Malawi: burden of disease and implications for prevention. Int J Surg. 2012;10(10):611-7. doi: 10.1016/j.ijsu.2012.10.004. Epub 2012 Nov 7.
citation: Samuel JC, Campbell EL, Mjuweni S, Muyco AP, Cairns BA, Charles AG. The epidemiology, management, outcomes and areas for improvement of burn care in central Malawi: an observational study. J Int Med Res. 2011;39(3):873-9. doi: 10.1177/147323001103900321.
Clinical trial NCT03852134: Milking of the Cut-Cord During Resuscitation of Preterm Infants (The MOCC Study)
Official title: Milking of the Cut-Cord During Resuscitation of Preterm Infants: A Randomized Controlled Trial (The MOCC Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Infant
Keywords: preterm infant
delayed cord clamping
cord milking
resuscitation
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 98
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this feasibility study, the investigators will randomize preterm infants born at \<32 weeks gestation to either the standard practice of delayed cord clamping (DCC) for 30-60 seconds at birth or milking of the long-cut cord (MOCC) while providing resuscitation/stabilization to the infant. The main objectives of the trial are to assess the feasibility of the new approach (MOCC) and to compare the two groups regarding the hemoglobin levels on admission to NICU in addition to neonatal morbidity and mortality.


Eligibility criteria: Inclusion Criteria:

* Preterm infants \<32 weeks' gestation

Exclusion Criteria:

* Clinical evidence of interrupted placental circulation (placental abruption or avulsed cord) or bleeding from placenta previa.
* Monochorionic twins or any higher order multiple pregnancy
* Major fetal congenital or chromosomal abnormality
* Documented fetal anemia or in utero red blood cell transfusion
* Intent to withhold or withdraw treatment of the infant

Primary outcomes:
measure: Rate of compliance to the study intervention
timeFrame: Two years
measure: Number of patients completing the study
timeFrame: Two years
measure: Number of adverse events associated with the MOCC intervention
timeFrame: Till the participants reach 2 year- corrected age (around 4.5 years)
Secondary outcomes:
measure: Compare hemoglobin (Hgb) concentration
timeFrame: From date of randomization and assessed up to 24 hours of age
Other outcomes:
measure: Temperature stability
timeFrame: From randomization assessed up to 2 hours of age
measure: Need for advanced resuscitation at birth
timeFrame: From randomization assessed up to 2 hours of age
measure: Inotropic support
timeFrame: From randomization assessed up to 72 hours of age
measure: Volume expander
timeFrame: From randomization assessed up to 72 hours of age
measure: Cerebral oxygenation
timeFrame: From randomization assessed up to 72 hours of age
measure: Blood transfusion
timeFrame: From randomization assessed up to 36 weeks corrected gestational age
measure: Intraventricular hemorrhage (IVH)
timeFrame: From randomization assessed up to 36 weeks corrected age
measure: Long-term outcomes
timeFrame: 24 Months Corrected age
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Walid El-Naggar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05815134: Cell Free DNA Quantification in Patients With Endometriosis Followed Witd Medical Assistance to Procreation
Official title: Cell Free DNA Quantification in Patients With Endometriosis Followed Witd Medical Assistance to Procreation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Endometriosis
Cell Free DNA
Keywords: Endometriosis
cell free DNA
oocyte quality
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Endometriosis is a common benign disease in premenopausal women and causes chronic pelvic pain and infertility. This infertility may be due to pelvic adhesions and surgery but also because of poor oocyte quality. It is known that endometriosis is associated with an increase oxidative stress, wich induce chronic inflammation, deleterious effect for DNA, proteins and can caused cellular death. ROS markers found in follicular fluid or in serum are significatively higher in endometriosis women. The investigators want to dose a marker of apoptosis in infertile women and see if it's significatively higher in serum and in follicular fluid of patients with endometriosis compared to others infertility causes and if it's correlated to oocyte quality and IVF results. Real time PCR will be used to dose cell free DNA in serum and follicular fluid of patients undergoing IVF treatment (endometriosis and infertility due to tubal factor, male infertility or idiopathic cause). Then the investigators will compare cell free DNA rate with oocyte and embryo quality and with pregnancy outcomes in the different group.


Eligibility criteria: Inclusion Criteria:

* patients eligible medical assistance to procreation who are about to undergo IVF treatment
* aged between 18 and 43 years old
* and who have signed a consent form

Exclusion Criteria:

* patients who are not eligible for medical assistance to procreation,
* patients who are followed for other inflammatory disease,
* patients followed for premature ovarian failure or
* patients with a recent story of pelvic infection

Primary outcomes:
measure: cell free DNA rate in serum in patients before they start IVF stimulation
timeFrame: day 1
measure: cell free DNA rate in follicular fluid the day of punction
timeFrame: day 1
Secondary outcomes:
measure: number of oocytes reaching the metaphase II
timeFrame: 1 year
measure: fragmentation rate
timeFrame: 1 year
measure: number of cells at day 2
timeFrame: day 2
measure: number of cells at day 3
timeFrame: day 3
measure: blastulation rate at day 5 of developement
timeFrame: day 5
measure: number of clinical pregnancy in both groups
timeFrame: 1 year
measure: number of live birth in both groups
timeFrame: 1 year
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
Study officials:
References:
Clinical trial NCT04000217: Written Versus Verbal Brief Cognitive Behavioral Exposure Therapy
Official title: A Randomized Control Trial Comparing Written Versus Verbal Brief Cognitive Behavioral Exposure Therapy Delivered Online
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Written Exposure Therapy
Imaginal Exposure Therapy
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the efficacy of two different versions of a brief online exposure therapy program for PTSD: written versus verbal trauma narrative recounting in reducing PTSD symptom severity. Both treatments will be delivered through an interactive online program with coaching from a trained peer support specialist. Treatment will be a variable length, such that 4 to 8 sessions will be delivered, depending on each participants' rate of PTSD symptom recovery.


Eligibility criteria: Inclusion Criteria:

* Able to read/write English
* Internet connection allowing stable access to the Vets Prevail website
* A clinically significant PCL-5 score of 31 or above.

Exclusion Criteria:

* A score on the suicidality item of the PHQ-9 of 3 or higher.

Primary outcomes:
measure: Post Traumatic Stress Disorder CheckList for Diagnostic and Statistical Manual - 5 (PCL-5; Weathers, et al., 2013)
timeFrame: Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer, & Williams, 2001).
timeFrame: Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).
measure: Brief version of the difficulties in emotion regulation scale (DERS-16; Bjureberg et al,. 2016)
timeFrame: Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).
measure: Work and Social Adjustment Scale (WSAS; Mundt et al., 2002)
timeFrame: Change in total score from baseline to 3-months post treatment (approximately 14-18 weeks).
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Prevail Health Inc.
state: Illinois
Study officials:
References:
Clinical trial NCT00551317: A Study Investigating the Concentrations of Darapladib in Blood and the Safety of This Compound in Healthy Japanese Men
Official title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of Darapladib (SB480848) in Healthy Japanese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atherosclerosis
Keywords: SB480848,
Japanese healthy volunteers
darapladib,
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-10-30
Enrollment: 18
Sex: MALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is being conducted to provide initial safety, tolerability, PK and PD data that will allow further studies with darapladib in Japanese patients


Eligibility criteria: Inclusion criteria:

* Japanese males, 20-64 years of age, inclusive
* Body weight \>50Kg
* Body Mass Index (BMI): 18-28
* Subjects must have lived outside of Japan no more than 10 years
* Non-smoker or smokes fewer than 10 cigarettes/day

Exclusion criteria:

* History of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses
* History of sensitivity to heparin or heparin-induced thrombocytopenia
* History of alcohol/drug abuse or dependence within 12 months of the study
* Positive syphilis, HIV antibody, Hepatitis B, Hepatitis C
* History of cholecystectomy or biliary tract disease or history of liver disease
* Participation in a clinical study within 30 days prior to first dose
* Subject has been exposed to more than 4 chemical entities within 12 months
* Positive urine drug and alcohol at screening
* Subject has any medical history or clinically relevant abnormality that would make the subject ineligible for inclusion due to safety reasons.

Primary outcomes:
measure: - Safety/tolerability of single oral doses of darapladib
timeFrame: 4, 24 and 96h post-dose
measure: - Primary Pharmacokinetic parameters of single oral doses of darapladib
timeFrame: pre-dose, 0,5, 1, 2, 3, 4, 6, 9 12, 16, 24, 48, 72h post-dose
Secondary outcomes:
measure: -Secondary PK parameters -PK parameters of SB553253 -inhibition of Lp-PLA2 activity -description of plasma concentration-Lp-PLA2 activity inhibition relationship after single oral doses of darapladib. all measured same timepoints as primary PK
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: GSK Investigational Site
state: Hawaii
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00291317: The Effect of FES on Children With Spinal Cord Injury
Official title: The Effect of FES on Children With Spinal Cord Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: pediatric spinal cord injury
FES cycling
bone mineral density
quality of life
Lead sponsor: Children's Specialized Hospital
Sponsor class: OTHER
Collaborators: name: University of Medicine and Dentistry of New Jersey
First posted: 2006-02-14
Enrollment: 6
Sex: ALL
Minimum age (years): 4
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Regular exercise is strongly recommended to help maintain a healthy lifestyle. Unfortunately, children and young adults with damaged spinal cords may not be able to exercise regularly. However, there is an exercise bike specially designed for persons with damaged spinal cords that enables them to pedal by directly stimulating the muscles in their legs. Our study is designed to determine the benefits of exercise for Spinal Cord Injured (SCI) patients using this bike.

Detailed description: The inability to walk due to spinal cord dysfunction has profound effects on patients, both physiologically and psychologically. Complications associated with walking upright include loss of muscle mass from atrophy, reduction in bone mineral density (osteoporosis), compromised cardiovascular endurance, loss of sense of well-being, etc. Functional Electrical Stimulation (FES) of the lower extremities has been found to reverse many of these complications. We propose to examine the use of FES in children who have suffered from spinal cord injury (SCI). We plan to examine the effect of FES bike therapy on bone mineral density and psychological well-being.

Eligibility criteria: Inclusion Criteria:

* Age 4-21
* Paralysis/lack of sensation in lower extremities due to spinal cord injury.

Exclusion criteria:

* Diseases known to affect bone metabolism
* A history of hip or knee dislocation or subluxation
* The presence of pressure sores in the areas of treatment
* The presence of metallic hardware in the femur
* A history of peripheral nerve injury, lower motor neuron disease, or chronic corticosteroid use; or a seizure disorder requiring pharmacological antiepileptic therapy that can affect bone mineral density.
* Individuals with pacemaker devices or unhealed fractures also were excluded.

Primary outcomes:
measure: Change in Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0)Score.
timeFrame: pre- and post-intervention; time frame among participants ranged from 4 to 12 months
measure: Change in Bone Mineral Density Measured Via DEXA Scan
timeFrame: At entry until completion (range 4-14 months) (One participant's DEXA scan was obtained late due to illness)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Specialized Hospital
name: Frank Castello, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06996717: Study of Rule-Based Algorithms in Anemia Management in Prevalent Hemodialysis Patients and Its Relation to Patients' Outcomes
Official title: Study of Rule-Based Algorithms in Anemia Management in Prevalent Hemodialysis Patients and Its Relation to Patients' Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Anemia in End Stage Renal Disease
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 145
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 will assess role of rule based algorithm in anemia management in hemodialysis patients and its relation to patient's mortality


Eligibility criteria: Inclusion Criteria:

* patients on hemodialysis for more than six months patients undergoing hemodialysis three times per week each session for 4 hours patients with urea reduction ratio\>65% patients with transferrin saturation\>20%

Exclusion Criteria:

* patients with terminal illness or malignancy patients receiving hemodialysis from catheter or arteriovenous graft

Primary outcomes:
measure: Increase the number of patients in the target Hb range
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hemodialysis Units in Ain Shams University Hospitals
Study officials:
References: