louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01490424: TREM-1 Gene Polymorphisms
Official title: Association Between TREM-1 Gene Polymorphisms and Prognosis in Sepsis Patient
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: TREM-1;
SNPs;
prognosis
control（normal person）
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2011-12-13
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects were selected from among inpatients who were hospitalized between September 2009 and October 2011 in the Respiratory ICU, Surgical ICU, and Emergency ICU, Chinese People's Liberation Army (CPLA) General Hospital.

Brief summary: Triggering receptor expressed on myeloid cells-1 (TREM-1) is a cell surface receptor expressed on neutrophils and monocytes. TREM-1 acts to amplify inflammation and serves as a critical mediator of inflammatory response in the context of sepsis. Blocking of TREM-1 can protect against sepsis in mice. This study was designed to investigate whether TREM-1 genomic variations were associated with the prognosis of sepsis. We sequenced 30 sepsis patients with TREM-1 gene of four exons by PCR sequencing. When analyzing the results of sequencing, we found two gene polymorphisms located in exon-2 and exon-4, respectively. Compare with the NCBI dbSNP and Hapmap database, one polymorphisms located in exon-2 is non-synonymous variation rs2234237（Ser25Thr）, the other one located in exon-4 is synonymous variation rs2234246. Two common polymorphisms (rs2234237,rs2234246) within the TREM-1 gene were detected in 80 patients with severe sepsis and in 80 healthy control subjects. This study was explored that whether or not polymorphisms detected within the TREM-1 gene may play a major role in the predisposition to prognosis of sepsis in a Chinese Han cohort.


Eligibility criteria: Inclusion Criteria:

* Sepsis met the criteria recommended by 1991 ACCP/SCCM Joint Meeting and by the diagnostic criteria developed at the 2001 International Sepsis Definition Conference.

Exclusion Criteria:

* (1) younger than 18 years of age; (2) acquired immunodeficiency syndrome; (3) reduced polymorphonuclear granulocyte counts (\< 500 μL-1); (4) died within 24h after admission into the ICU, or refused to participate in the study, or declined treatment during the period of observation.

Primary outcomes:
measure: Patients Outcome
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Respiratory Disease Department of chinese PLA General Hospital
name: Lixin Xie, MD
role: STUDY_DIRECTOR
References:
citation: Su L, Liu C, Li C, Jiang Z, Xiao K, Zhang X, Li M, Yan P, Feng D, Xie L. Dynamic changes in serum soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) and its gene polymorphisms are associated with sepsis prognosis. Inflammation. 2012 Dec;35(6):1833-43. doi: 10.1007/s10753-012-9504-z.
Clinical trial NCT04158024: Erector Spinae Plane Block in Congenital Heart Disease Patients
Official title: The Effect of Erector Spinae Plane Block on Neurodevelopmental Outcomes of Neonatal Congenital Heart Disease Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Congenital Heart Disease in Children
Neurologic Complication
Keywords: Erector Spinae Plane Blockade
Pediatric Congenital Heart Disease
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 150
Sex: ALL
Minimum age (years): 32
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pediatric cardiac patients undergoing surgical anesthesia are at an increased risk of poor neurologic outcome (20-50%). Unattenuated anesthetic exposure and pain contributes to physiologic perturbations that may increase neurologic morbidity. Because of the often-large exposure to anesthetic agents in these cardiac children, at such a young age and the potential modifying anesthetic practice that could lead to improved neurodevelopmental outcomes and surgical recovery is paramount. Regional anesthesia such as thoracic epidurals provide effective analgesia and reduced intraoperative anesthetic needed but carry devastating sequelae neurological risks of epidural hematomas after anticoagulation during cardiopulmonary bypass (CPB). Recently, a newly described erector spinae plane block (ESPB) is superficial to neuraxial or vascular structures, providing opportunity to be placed with less risk for surgery requiring CPB. This block has been described as effective regional anesthesia for adult cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Neonates of at least 32 weeks of gestation, infants and children admitted to The Lucile Packard Children's Hospital for treatment of cyanotic or non-cyanotic heart disease requiring surgical intervention.
* Admitting diagnosis of cyanotic or non-cyanotic heart disease

Exclusion Criteria:

* Neonates less than 32 weeks of gestational age
* Any documented central nervous system malformations.
* Any potential subject requiring unexpected postoperative Extracorporeal membrane oxygenation (ECMO) support

Primary outcomes:
measure: Length of Stay (LOS)
timeFrame: Through hospital stay, an average of 5 days
measure: Postoperative Opioid Consumption
timeFrame: Through hospital stay, an average of 5 days
measure: Comparing Changes in EEG Monitoring
timeFrame: Pre-operatively and up to 48 hours prior to discharge
measure: Neurological and Neurobehavioral Testing - Bayley III
timeFrame: 12-48 Months Post-Operatively
measure: Neurological and Neurobehavioral Testing - Capute Scale
timeFrame: 12-48 Months Post-Operatively
Secondary outcomes:
measure: Choline
timeFrame: 0-72 Hours
measure: Glutamate
timeFrame: 0-72 Hours
measure: N-Acetylaspartate
timeFrame: 0-72 Hours
measure: Lactate
timeFrame: 0-72 Hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01751334: Comparison of the Tibiofemoral Rotational Alignment After Mobile and Fixed Bearing Total Knee Arthroplasty
Official title: Comparison of the Tibiofemoral Rotational Alignment After Mobile and Fixed Bearing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Keywords: Arthroplasty
Replacement
Knee
Rotational Alignment
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-12-18
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The anatomic landmark for the anteroposterior (AP) axis of the proximal tibia and its variability was investigated in this study in order to determine whether a certain landmark could be employed as a reference axis for the proximal tibia after rotating platform mobile bearing (RP-MB) and fixed bearing (FB) total knee arthroplasties (TKAs).

Detailed description: Reference of tibial AP axis for implanting tibial component in total knee arthroplasty have not been concluded. This study can suggest appropriate method for alingning the tibial component to accurate tibial AP axis.

Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis

Exclusion Criteria:

* infection
* inflammatory arthritis
* reoperation
* severe deformity

Primary outcomes:
measure: Tibial anteroposterior axis relative to femoral anteroposterior axis
timeFrame: postoperative 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: Sahnghoon Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
name: Myung Chul Lee, M.D., Ph.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05352334: Comparison of High Intensity Interval Training Verses Aerobic Exercises on Emotional Intelligence of University Students
Official title: Comparison of High Intensity Interval Training Verses Aerobic Exercises on Emotional Intelligence of University Students
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High Intensity Interval Training
Aerobic Exercise
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2022-04-28
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The participants fulfilling the inclusion criteria will be selected from above mentioned different government and private universities. The total number of participants in data collection procedure will be 44. Informed consent will be taken from all the students and self-administered questionnaire will be distributed to students for data collection procedure. The emotional intelligence and physical activity will be measured and collected through Schutte self-report Emotional Intelligence test (SSCEIT) and international physical activity questionnaire. The questionnaires for physical activity will consist of 12 questions and for SSCEIT consist of 33 questions. Emotional intelligence will be measured by schutte self-report emotional intelligence scale and physical activity will be measured by international physical activity questionnaire.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: High Intensity Interval Training verses Aerobic Exercises on Emotional Intelligence of University Students

Detailed description: Null hypothesis: There is no difference in effects of high intensity interval training verses aerobic exercises on emotional intelligence of university students. Alternative hypothesis: there is difference in high intensity interval training and aerobic exercises on emotional intelligence of university students.

Eligibility criteria: Inclusion Criteria:

20-30 years old Both males \& females Previously involved in any physical activity will be included in this study.

Exclusion Criteria:

Insomnia, ADHD, schizophrenia, bipolar disorder\& depression, anxiety etc. Headache, epilepsy and seizures, stroke, Alzheimer disease , dementia \& Parkinson's disease Drugs \& alcohol abuse Any other known medical condition

Primary outcomes:
measure: Comparison of High Intensity Interval Training verses Aerobic Exercises on Emotional Intelligence of University Students
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Azra Naheed Medical College, Superior University
state: Punjab
Study officials:
References:
Clinical trial NCT01023334: Combined Intracameral Lidocaine for Manual Small Incision Cataract Surgery Under Topical Anesthesia
Official title: Combined Intracameral Lidocaine for Manual Small Incision Cataract Surgery Under Topical Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Topical analgesia
FlACC Pain Scale
intracameral lignocaine
Anesthetics
Physiological Effects of Drugs
Lidocaine
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2009-12-02
Enrollment: 200
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 determine whether intraocular lidocaine increases patient comfort during the different stages of MSICS while under topical anesthesia.


Eligibility criteria: Inclusion Criteria:

* Both men and women
* Cataract density grade III-V according to the Emery-Little system classification system
* Patients need to do manual small incision cataract surgery

Exclusion Criteria:

* Legal guardian(s) is/are not present for permission
* Any patient with a known sensitivity or allergy to Lidocaine or the "Caine" family of medicines.
* Patients with altered levels of pain perceptions

Primary outcomes:
measure: observed levels of pain
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hospital, Wenzhou Medical College
state: Zhejiang
Study officials:
affiliation: Eye Hospital, Wenzhou Medical College, China
name: Wei Chen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01781234: Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Abstinence Syndrome
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2013-01-31
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate safety and efficacy of intranasal insulin in abstinent smokers. Groups' (placebo vs. insulin) cognitive function and stress response will be compared.


Eligibility criteria: Inclusion Criteria:

* smokers (\>10 cig/day) for the past 1 year
* normosmic olfactory function

Exclusion Criteria:

* previous/current use of insulin
* current Diagnostic and Statistical Manual-IV-Revised (DSM-IV-R) Axis I disorder
* current pregnancy (or lactation)
* lifetime history of endocrine disease
* excessive alcohol use (\>25 standard units of alcohol/week)
* current use of illicit drugs
* current use of a smoking cessation aid (NRT, Chantix or Wellbutrin), or a psychotropic agent
* local infections, inflammation, structural abnormalities, or other nasal pathology
* current use of any medications administered intranasally, including intranasal steroids

Primary outcomes:
measure: Episodic Memory
timeFrame: 90 minutes
measure: Salivary Cortisol
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
measure: Nicotine Craving (Measured by Questionnaire of Smoking Urges)
timeFrame: 90 minutes
Locations:
city: Albuquerque
country: United States
facility: UNM College of Pharmacy
state: New Mexico
Study officials:
References:
Clinical trial NCT03498534: Evaluation of Diabetes Control and Effect on Transmission and Development of Tuberculosis
Official title: Evaluation of the Impact of Diabetes Control on Transmission and Development of Tuberculosis in the General Population
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Latent Tuberculosis
Diabetes Mellitus
Keywords: Treatment
Latent infection
Tuberculosis
Interferon gamma
Lead sponsor: Instituto Nacional de Salud Publica, Mexico
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Clinical test (essay) randomized to evaluate the toxicity adherence and efficiency of the chemoprophylaxis of tuberculosis (TB) in subjects with Diabetes Mellitus (DM) and latent TB. (600 subjects followed(continued) by 15 months). 3rd stage. Patients with DM and TB will be included to determine if the strict control of the dm achieved in clinics of the first level of attention improves clinical manifestations of tb, the result of treatment, the frequency of relapses, the mortality and the transmission to contacts.

Elispot will be used to measure TB development and the time for the bacteriological negativization and biochemical parameters as well as tuberculin skin test (TST), quantiferon, in contacts. (160 patients 600 contacts followed(continued) for 12 months). additional there will be evaluated the socioeconomic impact of both diseases and his(her) control. 1er year: transverse study and recruitment years 2 and 3 participants' follow-ups in clinical tests(essays).


Eligibility criteria: Inclusion Criteria:

* Positive HIV TST tuberculin

Exclusion Criteria:

* Previous TB treatment Hepatic failure AIDS

Primary outcomes:
measure: Development of active TB
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Institute of public Health
name: Garcia-Garcia Lourdes, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05694234: Influences of Sugammadex on Postoperative Progress in Patients With Myasthenia Gravis Undergoing Video-assisted Thoracoscopic Thymectomy: Retrospective Study
Official title: Influences of Sugammadex on Postoperative Progress in Patients With Myasthenia Gravis Undergoing Video-assisted Thoracoscopic Thymectomy: Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myasthenia Gravis
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 265
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with myasthenia gravis who underwent video-assisted thoracoscopic thymectomy

Brief summary: "Several case reports have described the use of rocuronium and sugammadex in patients with myasthenia gravis (MG). However, reports regarding the effects of sugammadex compared with that of acetylcholinesterase inhibitors (AChEIs) on perioperative outcomes of video-assisted thoracoscopic surgery (VATS)-thymectomy in patients with MG are still lacking. Thus, the investigators will investigate the effects of sugammadex compared to AChEIs on the postoperative recovery in patients with MG who underwent VATS-thymectomy.

This retrospective study include patients with MG, aged\> 18 years who received sugammadex or pyridostigmine-glycopyrrolate or neostigmine-glycopyrrolate after VATS-thymectomy between November 2007 and December 2020. Inverse Probability of Treatment Weighting (IPTW) adjustment will be performed to balance the baseline characteristics between the two groups. The primary outcome is the length of postoperative hospital stay, and the secondary outcomes are the incidence of postoperative mortality and postoperative complications, as well as postoperative extubation and reintubation rates in the operating room after VATS-thymectomy; the outcomes are compared between the two groups. "


Eligibility criteria: Inclusion Criteria:

* patients underwent VATS-thymectomy between November 2007 and December 2020

Exclusion Criteria:

* Patients who was not diagnosed with myasthenia gravis
* Age ≤ 18
* Patients for which no reversal agent was used

Primary outcomes:
measure: hospital stay
timeFrame: up to 1 year
Secondary outcomes:
measure: incidence of postoperative mortality
timeFrame: up to 1 year
measure: postoperative complication incidence
timeFrame: up to 1 year
measure: postoperative extubation rate in the OR
timeFrame: up to 1 year
measure: postoperative reintubation rate in the OR
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
name: Na Young Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02489734: Post Extubation Delirium and End-tidal Sevoflurane Concentration
Official title: Association Between Post Extubation Delirium and Pre-extubation End-tidal Sevoflurane Concentration in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium on Emergence
Keywords: sevoflurane
emergence delirium
preschool
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2015-07-03
Enrollment: 109
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the incidence of emergence delirium will be reduced when end-tidal concentration of sevoflurane decreases.

Detailed description: Sevoflurane induction and maintenance were selected. Intubation was performed after lidocaine spray on vocal cord. After that, an effective caudal or brachial plexus block was performed. End-tidal concentration of sevoflurane was maintained at 2.5%. Spontaneous respiratory was maintained. Sevoflurane was stopped after the end of surgery. Patients were randomly assigned to 2 groups: high concentration group (Group HC, end-tidal concentration of sevoflurane when extubating \>=0.5%) and low concentration group (Group LC, end-tidal concentration of sevoflurane when extubating \<0.5%). Patients in Group LC were extubated when they coughed or purposeful movement appeared. The patients whose end-tidal concentration of sevoflurane \>= 0.5% were excluded. Patients in Group HC were extubated when any of the criteria was met: 1.the patient coughed or purposeful movement appeared 2.end-tidal concentration of sevoflurane decreased to 0.5%. A trained nurse (blind to groups) recorded PAEDs scores in PACU.

Eligibility criteria: Inclusion Criteria:

* Age 2-7 years
* ASA I - II
* Estimated surgery time \< 2 hours
* Sevoflurane induction and maintenance along with caudal block or Axillary Block

Exclusion Criteria:

* Craniofacial anomalies
* Difficult exposure of the vocal cordS
* Obesity
* Asthma
* Invalid caudal block or axillary block

Primary outcomes:
measure: Number of Participants With Emergence Delirium (ED)
timeFrame: within 30 minutes after awakening
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Fudan University
name: Xuan Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03914534: Bioequivalence Study of Sodium Divalproate Tablets 500 mg
Official title: Bioequivalence Study of Sodium Divalproate Tablets 500 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: Tecnoquimicas
Sponsor class: INDUSTRY
First posted: 2019-04-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to establish the bioequivalence of two valproic acid formulations through the estimation of valproic acid in plasma samples, according to Food and Drugs Administration (FDA), World Health Organization (WHO) and Colombian National Vigilance Institute for Drugs and Food (INVIMA) guidelines.

Detailed description: This will be a single-center, open-label, four-period, two-treatment, two-sequence, randomized, single-dose, crossover study. 30 healthy adults will be randomized to receive a single dose (500 mg) of the test formulation of valproic acid and reference formulation of valproic acid separately in each treatment period. There will be two treatment sequences (AB, BA) and a 7 day washout between the two treatment periods.

Eligibility criteria: Inclusion Criteria:

* Men and Women from 18 to 50 years old
* Diagnosed as healthy after a clinical examination
* BMI from 18 to 30 kg/m2
* Not smoking for at least 3 months
* To sign the informed consent
* Not having participated in a similar study for at least 4 months

Exclusion Criteria:

* Renal, cardiac immunological, dermatological, endocrine, gastrointestinal, neurological or psychiatric condition
* Hematologic disorders, specially anemia and polycythemia
* Permanent or temporal pharmacological therapy, prescribed or not
* Smoking for the last 3 months
* Alcohol drinker more than once a week
* Drug abuse
* Drug hypersensitivity
* Angioedema or anaphylaxis history
* Pregnancy or breast-feeding
* HIV o Hepatitis B diagnosed
* Blood donor in the past 30 days

Primary outcomes:
measure: (AUC) Area Under the Curve 0-48
timeFrame: From 0 to 48 hours
measure: Cmax
timeFrame: From 0 to 48 hours
Secondary outcomes:
measure: Tmax
timeFrame: From 0 to 48 hours
measure: Kel
timeFrame: From 0 to 48 hours
Other outcomes:
Locations:
city: Chía
country: Colombia
facility: Universidad de la Sabana
Study officials:
References: