louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05696951: Tranexamic Acid in Sleeve Gastrectomy
Official title: Use of Tranexamic Acid in Postoperative Early Period Bleeding in Patients Undergoing Sleeve Gastrectomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tranexamic Acid Adverse Reaction
Keywords: tranexamic acid
Sleeve gastrectomy
Postoperative bleeding
Lead sponsor: Goztepe Prof Dr Suleyman Yalcın City Hospital
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 200
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: SUPPORTIVE_CARE

Brief summary: The effectiveness of Tranexamic acid use will be measured in cases of sleeve gastrectomy in bariatric surgery and in early postoperative bleeding.

Detailed description: Prospective, comparative and double-blind study with patients aged 18-65 years admitted to bariatric surgery. Selected patients were given or not given venous tranexamic acid (TXA) during anesthesia induction (CG). Anesthesia and thromboprophylaxis protocols were similar between groups. For statistical analysis, χ2 and analysis of variance tests were performed using the SPSS 21.0 ® statistical program at a significance level of p \< 0.05.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 65 years with an American Association of Anesthesiologists (ASA) physical condition score II or III
* undergoing bariatric surgery and LSG

Exclusion Criteria:

* history of thromboembolic disease or severe comorbidity (ASA IV or more)
* platelet antiaggregants or anticoagulants
* active intravascular coagulation carriers
* acute occlusive vasculopathy
* hypersensitivity to the components of the TXA formula.

Primary outcomes:
measure: effect on bleeding in the first one hours postoperatively
timeFrame: postoperative 1st hours
Secondary outcomes:
measure: effect on bleeding in the first 24 hours postoperatively
timeFrame: postoperative 24st hours
Other outcomes:
Locations:
city: Kadıköy
country: Turkey
facility: Göztepe Prof. Dr. Suleyman Yalcin City Hospital
state: İstanbul
Study officials:
affiliation: Goztepe Prof Dr Suleyman Yalcın City Hospital
name: medeni şermet, 1
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01380951: Safety and Efficacy of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B (CHB)
Official title: Clinical Study of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Liver Cirrhosis
Chronic Hepatitis B
Keywords: liver cirrhosis
chronic hepatitis B
antiviral therapy
telbivudine
Lead sponsor: The Fifth People's Hospital of Suzhou
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Antiviral treatment on Chronic Hepatitis B (CHB) patients with liver cirrhosis is compulsory and effective. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.

Detailed description: Antiviral therapy on CHB patients with liver cirrhosis is compulsory and effective. Diseases development can be prevented or delayed if the virus is depressed successfully. Lamivudine is often used and usually has good efficacy. However, lamivudine resistance and virus mutation happens a lot. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.

Eligibility criteria: Inclusion Criteria:

* liver cirrhosis with CHB
* without history of antiviral therapy or discontinued antiviral therapy for more than 6 months
* for patients with compensated liver cirrhosis: HBV DNA≥4log copies/ml if HBeAg positive,HBV DNA≥3log copies/ml if HBeAg negative
* for patients with uncompensated liver cirrhosis:HBV DNA positive

Exclusion Criteria:

* coinfection with HCV,HDV and HIV
* AFP≥100mg/L or HCC diagnosed by iconography
* with severe cardiovascular, respiratory and endocrinology diseases or autoimmune diseases

Primary outcomes:
measure: Serum HBV DNA
timeFrame: 48 weeks
Secondary outcomes:
measure: Serum HBeAg
timeFrame: 48 weeks
measure: Child-pugh score
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Suzhou
country: China
facility: the Fifth People's Hospital of Suzhou
state: Jiangsu
Study officials:
affiliation: The Fifth People's Hospital of Suzhou
name: Chuanwu Zhu, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00664651: Joint Stiffness Following Knee Replacement Surgery
Official title: Capsular Changes in Joint Contractures Post-Knee Arthroplasty:A Case-Control Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Joint Contracture
Keywords: joint contracture
total knee arthroplasty
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2008-04-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: joint contractures following knee surgery

Brief summary: Our primary research question is to find out whether there is a genetic component to the development of joint contractures following knee surgery, through the application of lab techniques.

Detailed description: After total knee replacement surgery, some people develop joint stiffness, which is also called a joint contracture. Contractures cause the envelope of the knee (called the capsule) to stiffen and become rigid so the patient can no longer move their knee the way they used to. After stretching and other exercises, only a surgery can try and divide or remove the contracture. The main purpose of this research is to study the cause of the contracture and specifically if certain people are predisposed to contractures.

Eligibility criteria: Inclusion Criteria:

-knee contractures post arthroplasty scheduled for arthrotomy with debridement of capsular tissue Controls will be patients scheduled for arthrotomy with debridement of capsular tissue for the other reasons(primary knee arthroplasty, ORIF of the knee secondary to trauma, ACL repair, amputation, elective joint arthroplasty with capsuloplasty etc.)

Exclusion:

* transmissible disease (HIV, Hep B,C)
* confirmed or suspected neoplasia
* suspected infection

Primary outcomes:
measure: Gene expression
timeFrame: Dec 2015
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: OHRI / The Ottawa Hospital
name: Guy Trudel, MD,MSc,FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04235751: Effect of Coaching on Surgeon Well-Being, Job Satisfaction, & Fulfillment
Official title: Effect of Coaching on Surgeon Well-Being, Job Satisfaction, & Fulfillment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Professional Burnout
Professional Stress
Job Stress
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-01-22
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Researchers are trying to determine if individualized professional coaching improves physicians' sense of well-being and job satisfaction.


Eligibility criteria: Inclusion Criteria:

* Surgeons at Mayo Clinic

Exclusion Criteria:

* Retired surgeons at Mayo Clinic; physicians in other disciplines or organizations

Primary outcomes:
measure: Burnout
timeFrame: Baseline, 6 months
measure: Job Satisfaction
timeFrame: Baseline, 6 months
measure: Professional Fulfillment
timeFrame: Baseline, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Liselotte N Dyrbye, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00914251: Vascular Effects of Hesperidin in Metabolic Syndrome
Official title: Positive Vascular Effect of Hesperidin in Subjects Affected by Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Endothelial Dysfunction
Metabolic Syndrome
Keywords: endothelial
metabolic syndrome
hesperidin
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2009-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: It has been suggested that cardiovascular risk factors either independently or in cluster (metabolic syndrome) increase the risk of both type 2 diabetes (DM2) and cardiovascular diseases (CVD). Consumption of citrus fruits is linked to reduced cardiovascular morbidity and mortality. Hesperidin is a flavanone abundant in citrus fruit with putative vasodilator actions in vitro. While molecular mechanisms of vascular actions of hesperidin begin to be explored, no data on in vivo vascular effect of this flavanone has been ever acquired.


Eligibility criteria: Inclusion Criteria:

* Metabolic Syndrome (ATPIII criteria)
* BMI \<35
* Age 20-55

Exclusion Criteria:

* History of cancer.
* History of cardiovascular diseases.
* Any other acute or chronic illness which requires administration of steroids or other drugs able to interfere with glucose or lipid metabolism.

Primary outcomes:
measure: Safety of oral supplementation of hesperidin
timeFrame: 3 weeks
Secondary outcomes:
measure: Endothelial function assessed by FMD %. Inflammatory status assessed by biochemical markers.
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University of Rome Tor Vergata
Study officials:
References:
citation: Muniyappa R, Hall G, Kolodziej TL, Karne RJ, Crandon SK, Quon MJ. Cocoa consumption for 2 wk enhances insulin-mediated vasodilatation without improving blood pressure or insulin resistance in essential hypertension. Am J Clin Nutr. 2008 Dec;88(6):1685-96. doi: 10.3945/ajcn.2008.26457.
citation: Collins QF, Liu HY, Pi J, Liu Z, Quon MJ, Cao W. Epigallocatechin-3-gallate (EGCG), a green tea polyphenol, suppresses hepatic gluconeogenesis through 5'-AMP-activated protein kinase. J Biol Chem. 2007 Oct 12;282(41):30143-9. doi: 10.1074/jbc.M702390200. Epub 2007 Aug 27.
citation: Rizza S, Muniyappa R, Iantorno M, Kim JA, Chen H, Pullikotil P, Senese N, Tesauro M, Lauro D, Cardillo C, Quon MJ. Citrus polyphenol hesperidin stimulates production of nitric oxide in endothelial cells while improving endothelial function and reducing inflammatory markers in patients with metabolic syndrome. J Clin Endocrinol Metab. 2011 May;96(5):E782-92. doi: 10.1210/jc.2010-2879. Epub 2011 Feb 23.
Clinical trial NCT03338751: Determine the Effect on Cognitive Impairment Measures by Providing Hearing-Assistance to Skilled Nursing Facility Residents
Official title: Determine the Effect on Cognitive Impairment Measures by Providing Hearing-Assistance to Skilled Nursing Facility Residents
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hearing Impairment
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the study is to see if a commercially available hearing assistance device called the PockeTalker has an effect on performance on cognitive (memory and thinking) tests among skilled nursing facility residents.

Investigators are asking residents to perform cognitive tests with and without hearing assistance equipment known as PockeTalkers. This study will be conducted at one urban Skilled Nursing Facility (SNF) with the goal of understanding the extent to which hearing impairment impacts commonly used cognitive impairment measures for clinical assessment. Cognitive performance will be measured, cerumen occlusion, and perceived hearing.


Eligibility criteria: Inclusion Criteria:

* admitted to unit of intervention
* ability to communicate and follow simple commands
* capacity to consent assessed with standard questions used to assess capacity or having a surrogate who can provide consent.

Exclusion Criteria:

* not on the unit of intervention
* obtunded or comatose state
* inability to communicate verbally
* inability to consent and without surrogate
* non-English speaking

Primary outcomes:
measure: Measure of Cognitive function using Mini-Cog
timeFrame: 20 Minutes
measure: Perceived Hearing measured by Hearing Handicap Inventory for the Elderly-Screening Version (HHIE)
timeFrame: 20 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Joshua Chodosh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01068951: Treatment of Patients With Newly Onset of Type 1 Diabetes With Mesenchymal Stem Cells
Official title: Open Study to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells in Treatment of Recently Diagnosed Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
mesenchymal stem cells
intervention
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
First posted: 2010-02-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The main hypothesis of the investigators study is that the development of autoimmune diabetes may be halted att diagnosis by the immune modulatory properties of mesenchymal stem cells.


Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent
* Mentally stable and able to comply with the procedures of the study protocol
* Clinical history compatible with type 1 diabetes diagnosed less than 10 days of enrolment Stimulate c-peptide \>0.1 nmol/l

Exclusion Criteria:

* Patients with BMI\>30
* Patients with unstable cardiovascular status
* Patients with active infections, unless treatment is not judged necessary by the investigators
* Patients with serological evidence of infection with HIV, hepatitis B or hepatitis C.
* Sexually active females who are not a) postmenopausal, b) surgically sterile or c) using an acceptable method of contraception: oral contraceptives, Norplant, Depo-provera and barrier devices combined with spermicidal gel are acceptable.
* Patients with known or previous malignancy. Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with autologous MSC.

Primary outcomes:
measure: The concentration of stimulated c-peptide at 90 minutes after the start of a mixed meal tolerance test at 365+/-10 days following the infusion or not with mesenchymal stem cells
timeFrame: 1 year after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University Hospital
name: Per-Ola Carlsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carlsson PO, Schwarcz E, Korsgren O, Le Blanc K. Preserved beta-cell function in type 1 diabetes by mesenchymal stromal cells. Diabetes. 2015 Feb;64(2):587-92. doi: 10.2337/db14-0656. Epub 2014 Sep 9.
Clinical trial NCT00428051: Colombia Epidemiologic Surveillance Study
Official title: Multinational Latin American Epidemiologic Surveillance For Invasive Pneumococcal Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pneumonia
Meningitis
Bacteremia
Sepsis
Keywords: Epidemiology
Surveillance
Streptococcal Pneumonia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-01-29
Enrollment: 32867
Sex: ALL
Minimum age (years): 28
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Epidemiologic study that will include children 28 days to 36 months of age that meet entrance criteria

Brief summary: The study will determine the reduction in invasive pneumococcal disease (IPD) after the introduction of a National Immunization Program with PCV-7 in Bogota. The original LEAP study determine incidence of IPD prior to introduction of PCV-7 in Brazil, Costa Rica and Colombia. LEAP II is the continuation of the study in Colombia only.

Detailed description: The study was stopped based on a decision to include PCV 10 in the National Immunization Program in Colombia. The study was designed to measure the impact of PCV 7 and 13 and is no longer feasible.

Eligibility criteria: Inclusion Criteria:

* Children 28 days to 36 months of age
* Presenting to a participating facility with a measured temperature of 39 degrees C or higher within 24 hours prior to screening, or with clinical suspicion of pneumonia, meningitis, bacteremia, sepsis, or other invasive pneumococcal disease

Exclusion Criteria:

* Any patient hat based on the clinical impression of the treating physician should not participate in the study: examples such as those with suspected dengue or urinary tract infection

Primary outcomes:
measure: Annual age specific incidence rate of invasive pneumococcal disease based on the number of identified cases from the study sites and the size of the population at risk for children 28 days to 36 months of age
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: Pfizer Investigational Site
state: Goias
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
city: La Uruca
country: Costa Rica
facility: Pfizer Investigational Site
state: San Jose
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Benavides JA, Ovalle OO, Salvador GR, Gray S, Isaacman D, Rodgers GL. Population-based surveillance for invasive pneumococcal disease and pneumonia in infants and young children in Bogota, Colombia. Vaccine. 2012 Aug 31;30(40):5886-92. doi: 10.1016/j.vaccine.2012.03.054. Epub 2012 Apr 4.
Clinical trial NCT00892151: Evaluation of GLUCOFACTS® Deluxe Diabetes Management System
Official title: Evaluation of GLUCOFACTS® Deluxe Diabetes Management System In a Clinical Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2009-05-04
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate a Diabetes management program in the hands of potential users, both health care professionals and lay persons.

Detailed description: Diabetes data management programs upload glucose meter results to computers to provide information at home to lay people with diabetes and their healthcare professionals to manage their diabetes. The study evaluated the subjects' success using the software program with a blood glucose meter to perform specific tasks, such as uploading the meter results, changing program and meter settings, and displaying reports. The study also evaluated the system's ease of use and the acceptability of product labeling.

Eligibility criteria: Inclusion Criteria:

Lay users must:

* Be at least 18 years of age (at least 80% must be 55 years or less)
* Have diabetes or be the parent or legal guardian of a child with diabetes who routinely test their blood sugar at home
* Be testing blood sugar at home at least twice daily for at least one month or be the parent or legal guardian of a child who has been testing blood sugar at home at least twice daily for at least one month
* Be able to speak, read, and understand English
* Have experience using PC programs or browsing the internet
* Have utilized diabetes management software at home in the last year (at least 75% of lay users) or be familiar with diabetes management software

HCPs must:

* Have experience using diabetes data management software in the medical office or assist in patients' diabetes disease management using software

Exclusion Criteria:

* Person working for a competitive medical device company
* Person having a cognitive disorder or condition which, in the opinion of the investigator, would put the person at risk or compromise the integrity of the study.

Primary outcomes:
measure: Number of Participants Rated Successful (<=3) at Performing Specific Tasks
timeFrame: 1-2 hours
Secondary outcomes:
measure: Percentage of Participants Who Rated Ease of Performing Specific Tasks As <=3
timeFrame: 1-2 hours
measure: Number of Participants Who Rated Clarity and Usefulness of User Instructions as >=3
timeFrame: 1-2 hours
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
Study officials:
affiliation: AMCR Institute
name: Timothy Bailey, MD
role: PRINCIPAL_INVESTIGATOR
References: