louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04685278: Anticardiolipin Autoantibodies and Mortality in Septic Patients
Official title: Anticardiolipin Autoantibodies as Useful Biomarker for the Prediction of Mortality in Septic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Morality
Keywords: anti-phospholipid
sepsis
intensive care unit
Lead sponsor: Military Hospital of Tunis
Sponsor class: OTHER
First posted: 2020-12-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients, admitted to the ICU for sepsis

Brief summary: The detection of antiphospholipid antibodies (aPL) is of interest because of their importance in the pathogenesis of arterial or venous thrombosis and their responsibility for a wide spectrum of clinical manifestations such as infection. The aim of the study was to assess the performance of antiphospholipid antibodies biomarker to predict in- hospital mortality in intensive care unit (ICU) septic patient's.

Detailed description: the investigators conducted a prospective single-center observational study including consecutive critically ill septic adults admitted to the intensive care unit. Clinical and laboratory data including chemiluminescence immunoassay for antiphospholipid antibodies \[anticardiolipin (aCL), antiphosphatidylserine (aPS)\] were obtained. Blood samples were collected on days 1, 3, 5, 8 and 10 of hospitalization. The primary study endpoint was ICU mortality defined as death before ICU discharge. Secondary end points included correlation between SOFA score and biological parameters.

Eligibility criteria: Inclusion Criteria:

* patients, admitted to the ICU for sepsis and older than 18 years

Exclusion Criteria:

* pregnancy
* clinical history of antiphospholipid syndrome
* auto-immune diseases
* immunosuppressive treatment

Primary outcomes:
measure: ICU mortality
timeFrame: mortality at day 14 of hospitalization
Secondary outcomes:
measure: correlation between SOFA score and antiphospholipid antibodies.
timeFrame: on days 1, 3, 5, 8 and 10 of hospitalization
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Military Hospital of Tunisia
Study officials:
affiliation: Military Hospital of Tunis
name: Iheb Labbene, Pr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01047878: Genomic Analysis of Pediatric Bone Tumors
Official title: Genomic Analysis of Pediatric Bone Tumors (Other Title: Pediatric Bone Tumor Biology Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-01-13
Enrollment: 163
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with bone x-rays suggestive of a malignant bone tumor

Brief summary: To determine whether gene expression analysis of primary tumor samples before and after chemotherapy are predictive of long-term survival in pediatric patients with bone sarcomas (Ewings sarcoma (ES) and Osteosarcoma(OS)).


Eligibility criteria: Inclusion Criteria:All patients with bone x-rays suggestive of a malignant bone tumor Exclusion Criteria:Patients with a known diagnosis of cancer.

Primary outcomes:
measure: % necrosis post chemotherapy
timeFrame: his is measured at the time of sample collection since we are looking for % necrosis in the sample we are collecting
measure: overall survival and event free survival
timeFrame: This is measured at the time the patient dies, or at the time when patient relapses from their disease. There is no set time since this outcome is individually assessed.
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Arun A Rangaswami
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00535678: Testing Digital Breast Tomosynthesis vs. Regular Mammogram in Detecting Breast Cancer in Women Having Screening Mammogram
Official title: A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 1. Women Undergoing Screening Mammography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Mammography
mammogram
breast
Abnormal and normal breast tissue
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women referred for normal screening mammogram

Brief summary: To compare DBT and FFDM for screening effectiveness in women who present for screening mammography with respect to screening recall rate.


Eligibility criteria: Inclusion Criteria:

* Women ≥18 years or older for screening mammography
* Able and willing to comply with study procedures, and have signed and dated the informed consent form
* The subject is surgically sterile or postmenopausal

Exclusion Criteria:

* Pregnant or trying to become pregnant
* Has signs or symptoms of breast cancer
* Has been previously included in this study
* Has breast implants
* Has a history of breast cancer and is in active treatment
* Has breasts too large to be adequately positioned for the DBT examination

Primary outcomes:
measure: Compare the diagnostic performance of FFDM and DBT in detecting and excluding breast cancer in asymptomatic women.
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: GE Healthcare
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Amy Longcore
role: STUDY_DIRECTOR
References:
Clinical trial NCT06285578: Effects of Probiotic and HIIT in Obese Women
Official title: Effects of Probiotic With HIIT on Cardiorespiratory Endurance and Metabolism in Middle-Aged Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiorespiratory Fitness
Metabolism
Anthropometry
Lead sponsor: University of Taipei
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 47
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to investigate whether there are the additive effects when implementing both high-intensity interval training (HIIT) and probiotics simultaneously on improving cardiorespiratory endurance and metabolism in middle-aged women.

Detailed description: High-intensity interval training (HIIT) is a time-efficiency exercise mode that has been shown to reduce body fat, fasting blood insulin levels, arterial stiffness, and aerobic capacity, helping to prevent and improve chronic diseases. Probiotics, on the other hand, have been found to have similar effects, including improving insulin sensitivity and endurance exercise performance, as well as reducing body fat. However, the additive effects of HIIT combined with probiotic supplements are unclear. In addition, on average, the life expectancy of women is longer than that of men. Middle-aged women are at high-risk for obesity and metabolic-related problems that threaten their long-term health. Therefore, whether the combination of HIIT and probiotics can be utilized to enhance the wellness of middle-aged women is the objective of this study.

Eligibility criteria: Inclusion Criteria:

* Female
* Age between 35-55 years old
* Total body fat percentage greater than 30%

Exclusion Criteria:

* Male
* Participants who were taking probiotics supplementation or antibiotics
* Percentage of total body fat less than 30%

Primary outcomes:
measure: Height
timeFrame: 8 weeks
measure: Body weight
timeFrame: 8 weeks
measure: Body mass index (BMI)
timeFrame: 8 weeks
measure: Body fat percentage
timeFrame: 8 weeks
measure: Waist circumference
timeFrame: 8 weeks
measure: Hip circumference
timeFrame: 8 weeks
measure: Maximum oxygen uptake (VO2max)
timeFrame: 8 weeks
measure: Time to exhaustion (TTE)
timeFrame: 8 weeks
measure: Running economy (RE)
timeFrame: 8 weeks
measure: Fasting blood glucose (FBG)
timeFrame: 8 weeks
measure: Total cholesterol (TC)
timeFrame: 8 weeks
measure: Triglyceride (TG)
timeFrame: 8 weeks
measure: High-density lipoprotein cholesterol (HDL-C)
timeFrame: 8 weeks
measure: Low-density lipoprotein cholesterol (LDL-C)
timeFrame: 8 weeks
Secondary outcomes:
measure: Muscle mass
timeFrame: 8 weeks
measure: Fat mass
timeFrame: 8 weeks
measure: Bone mineral density (BMD)
timeFrame: 8 weeks
measure: Caloric intake
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: University of Taipei
Study officials:
affiliation: University of Taipei
name: Chien-Wen Hou, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00586378: Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study
Official title: Ovatio DR and VR Implantable Cardioverter Defibrillators Post-approval Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sudden Cardiac Death
Lead sponsor: ELA Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2008-01-04
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this post-approval study is to confirm the safety and effectiveness of Ovatio DR and VR ICDs


Eligibility criteria: Inclusion Criteria:

* Candidates will come from the investigator's general ICD population who meet any of the accepted indications for an ICD implant according to the "ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death" (Zipes et al., JACC Vol. 48, No. 5, Sept. 2006:1064-1108).

Exclusion Criteria:

* Ventricular tachyarrhythmia that may have transient or reversible causes such as: acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia, sepsis, or unstable ischemic episodes
* Incessant tachyarrhythmia
* Implanted pacemaker
* Primary disorder of bradyarrhythmia or atrial tachyarrhythmia
* Of minor age
* Pregnant
* Participating in another clinical study

Primary outcomes:
measure: The percentage of patients free from complications
timeFrame: 6 months
measure: Shock effectiveness for VT/VF
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Banner Baywood
state: Arizona
Study officials:
affiliation: ELA Medical, Inc.
name: Mark J Schwartz, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT06514378: Safety of Endobronchial Mesenchymal Stromal Cells in the Treatment of Chronic Lung Allograft Dysfunction
Official title: An Open Label, Randomised, Controlled Clinical Trial to Asses the Safety of Endobronchial Administration of Allogneic Mesenchymal Stromal Cells in Patients With Lung Trasplant Chronic Rejection: Endosclad Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Chronic Lung Disease
Lung Transplant Rejection
Lead sponsor: Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana
Sponsor class: OTHER
Collaborators: name: Ministerio de Ciencia, Innovación y Universidades
First posted: 2024-07-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Lung transplantation is the only therapeutic alternative for more and more patients with respiratory diseases in their most advanced stages.

The most limiting factor to achieve long term survival si chronic lung allograft dysfunction, a multifactorial disease without an effective treatment.

The immunomodulatory capacity of mesenchymal stem cells enables them to be a potential therapeutic agent for this condition.

The objective of this study is to assess the safety of endobronchial administration of allogeneic MSCs in patients with chroniclung allograft dysfunction.


Eligibility criteria: Inclusion Criteria:

Patients should have signed written informed consent. Adult patients ≥18 years of age at the time of enrolment Patients recipients of a uni or bipulmonary transplant An established diagnosis of BOS ≧ 0p (FEV1≤90% and / or FEF 25-75% ≤ of the baseline value with no other justifying cause) in the last 6 months.

Exclusion Criteria:

* History of lobar transplantation History of heart-lung transplantation Active infection at the time of inclusion. Active Acute Rejection not treated at the time of inclusion. Oncological history (except cutaneous basal cell or carcinoma in situ) Systemic autoimmune diseases. Active HIV / HBV / HCV infection (confirmed by serology or PCR) Proximal airway stenosis Pregnancy Performance status 3 or 4 (confined to bed or chair for more than 50% of waking hours, able only to perform some self-care activities) Estimated survival less than 3 months. Known hypersensitivity to components used in the production of allogeneic MSCs. Any circumstance that, in the opinion of the investigator, compromises the patient's ability to participate in the clinical trial.

Primary outcomes:
measure: Early onset adverse events
timeFrame: 24 hours
measure: Adverse events
timeFrame: One year since randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
Study officials:
References:
Clinical trial NCT00807378: Rijavithi Viral and Mycobacterium PCR Arrays in CNS Infection Study
Official title: Cerebrospinal Fluid Polymerase Chain Reaction Arrays for Central Nervous System Neurotropic Viral Infection and Mycobacterium Infection Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CNS Viral Infection
Keywords: CNS viral infection
PCR
HYBRIDIZATION
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
Collaborators: name: Rajavithi Biomolecular Research Center
First posted: 2008-12-11
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CNS VIRAL INFECTION AIDS/NON-AIDS

Brief summary: This study of neurotropic viral infection and Tuberculous CNS infection is the comprehensive investigation of CSF PCR arrays (Hybrydiaztion technique,Sybergreen and Taqman real time PCR arrays of CSF ) in suspected cases of viral CNS infection, Tuberculous CNS infection in both AIDS and non AIDS patients.

Patients with clinical viral encephalitis and all meningoencephalitis including all patients with HIV/AIDS CSF and non AIDS will be banked and test for RNA and DNA viral sequence by Real time PCR arrays and IS6110 gene of Mycobacterium tuberculosis. Clinical data and final diagnosis will be used to analyze the result of this PCR arrays technique compared to clinical gold standard criteria.


Eligibility criteria: Inclusion Criteria:

1. AGE MORE THAN 15 YRS
2. ABLE TO INFORM CONSENT BY THEMSELF OR THEIR PARENT
3. SUSPECTED CNS VIRAL INFECTION

Exclusion Criteria:

1. UNABLE/CONTRAINDICATED FOR LUMBAR PUNCTURE OR CSF COLLECTION
2. WITHDRAW CONSENT
3. SUSPECTED SEVERE OR VILURENT VIRAL INFECTION SUCH AS H5N1/SARS INFECTION

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04310878: Gaps Between Evidence and Practice in Prevention of Surgical Site Infection in Spain
Official title: Gaps Between Evidence and Practice in Prevention of Surgical Site Infection in Spain: A Survey of the Observatory of Infection in Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Site Infection
Keywords: Surgical site infection
Preventative measures
Lead sponsor: Hospital de Granollers
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Perioperative nurses and surgeons of 11 invited Spanish societies

Brief summary: Web-based survey to members of 10 Spanish Associations of surgical nurses and surgeons of different specialities to know the application of preventative measures for surgical site infection.

Detailed description: A web-based survey to the members of the Colorectal Chapter of 10 Spanish Associations of surgical nurses and surgeons of different specialities. A link to the web page containing the survey will be disseminated via email, newsletter and Twitter.

A board from the Surgical Infection Section did a review of evidence and previous guidelines to be used in the evaluation of the results. The most recent clinical practice guidelines have been analysed. According to the review, the preventive measures analysed in the survey have been distributed into two groups: high or low level of evidence.

The survey aim to assess knowledge, beliefs, and practices of attending nurses and surgeons on preventative measures. Furthermore, the questions address the level of accordance between their beliefs and the protocols or the usual practice of their units. The agreement rate between the beliefs and usual practice of all respondents will be calculated on a scale from 0 to 100. For discussion, the responses on the implementation of major surgical site infection (SSI) prevention measures will be compared with the recommendations of the expert group.

The results will be expressed in percentages on the total answers obtained. Responses will be entered into a computerized database that will be analysed using an specific program. The results will be analysed using the chi-square test with statistical significance defined as p \<0.05.

Eligibility criteria: Inclusion Criteria:

* Nurses and surgeons pertaining to invited societies

Exclusion Criteria:

* None

Primary outcomes:
measure: Awareness of practice
timeFrame: 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Granollers
country: Spain
facility: Fundació Privada Hospital Asil de Granollers
state: Barcelona
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Josep Badia-Perez, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02371707: Bioequivalence Study of Idalopirdine Tablets 60 mg
Official title: Interventional, Randomised, Open-label, Two-way Crossover, Single-dose Bioequivalence Study of Idalopirdine in Healthy Subjects Comparing the 60 mg Commercial Tablet (Test) to the 60 mg Clinical Tablet (Reference)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2015-02-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to establish bioequivalence between two tablet formulations of idalopirdine


Eligibility criteria: Inclusion Criteria:

* Healthy men and women

  -≥18 and ≤55 years of age
* body mass index (BMI) of \>18.5 and \<30 kg/m2

Exclusion Criteria:

* Pregnant and lactating women

Other protocol defined inclusion and exclusion criteria may apply

Primary outcomes:
measure: Area under the idalopirdine plasma concentration-time curve
timeFrame: 0 to 72 hours post-dose
measure: maximum observed concentration (Cmax) of idalopirdine
timeFrame: 0 to 72 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT06595407: Loss of Y Chromosome in Aortic Stenosis
Official title: Loss of Y Chromosome in Aortic Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Stenosis
Keywords: Aortic stenosis
Y-chromosome
Transforming growth factor-beta
Echocardiography
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 200
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males with calcific, non-congenital aortic stenosis and age-matched males without aortic stenosis.

Brief summary: The most common heart valve disease in humans is aortic stenosis which is a critical narrowing of the valve through which the heart has to pump blood to the rest of the body. This condition occurs in 2-3% of adults over 65 years of age and when it progresses to a severe stage leads to heart failure and need for valve replacement procedures (including surgery and catheter-based replacement). Aortic stenosis has a strong male predominance. The purpose of this study is to evaluate whether loss of Y-chromosome from circulating blood cells in males, which has been associated with TGF-beta-related fibrosis of other organs, is associated with the development of aortic stenosis.


Eligibility criteria: Inclusion Criteria:

* Aortic stenosis (valve area \&lt;1.5cm2)

Exclusion Criteria:

* Bicuspid aortic valve
* History of radiation to chest
* Inflammatory (autoimmune, rheumatologic) disease associated with aortic stenosis
* Active cancer

Primary outcomes:
measure: Loss of Y chromosome
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: