louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03275610: Genetic Markers of Patients With History of Pulmonary Embolism Post Total Joint Arthroplasty
Official title: Risk Stratification Using Genetic Markers of Patients With a History of Pulmonary Embolism Post Total Hip or Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pulmonary Embolism
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Established patients with a history of Pulmonary Embolism Post Total Hip Arthroplasty or Post Knee Arthroplasty

Brief summary: This study seeks to uncover potential genetic determinants of pulmonary embolism (PE). Our translational goal is to ultimately identify certain genetic markers that will allow us to stratify patients in terms of their PE risk post total knee or total hip arthroplasty. The clinical implications for this study would allow for better patient care by lowering the risk of post-operative bleeding while still preventing symptomatic PEs and deep vein thromboses (DVTs). We look to sample patients who have a history of PE after undergoing total knee or total hip arthroplasty. We will sample these patients' blood DNA for a set of DNA genetic markers. To do so, we will utilize the Taqman assay, which is a PCR-based 5'-nuclease allelic discrimination assay to determine single nucleotide polymorphism (SNP) genotypes at specified loci. The region flanking the SNP is amplified using two allele-specific fluorescent probes, allowing for the detection of each allele in a single tube. Using this assay, there is no post-PCR processing because the probes are included in the PCR reaction (Hui). Using this approach, we will measure the frequency of genetic mutations in patients who have developed a PE after a total joint arthroplasty. This data would then be used to perform a prospective study to determine a subset of genetic markers that can definitively be used to risk stratify patients.


Eligibility criteria: Inclusion Criteria:

* patients with a history of Pulmonary Embolism and Total Hip Arthroplasty or Total Knee Arthroplasty, between the ages of 18 and 70 years

Exclusion Criteria:

Primary outcomes:
measure: Identification of Genetic Mutations
timeFrame: 6 weeks Post Total Hip Arthroplasty or Post Total Knee Arthroplasty
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Jay R Lieberman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04956510: Osteoarthritis in Terms of ICF Components
Official title: Investigation of Individuals With Osteoarthritis in Terms of ICF Components Based of ICF Comprehensive Core Set for Osteoarthritis and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Quality of Life
OUTCOME MEASURES
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Eighty-seven patients with OA were included in this study, who met inclusion criteria and were diagnosed with OA by the same rheumatologist according to the American College of Rheumatology Clinical Classification Criteria for OA.

Brief summary: Osteoarthritis (OA) is a common degenerative disease associated with functional impairments, activity limitations, participation restrictions, as well as poor quality life. Therefore, the comprehensive assessment is important to determine how complex problems affect patients with OA. The first aim of this study was to link and allocate items of The Western Ontario and McMaster Universities (WOMAC) OA index with ICF Comprehensive Core Set for osteoarthritis. The second aim was to examine the relationship between the quality of life and each ICF component's scores determined based on clinical data of WOMAC in OA.


Eligibility criteria: Inclusion Criteria:

* diagnosed with OA according to American College of Rheumatology clinical criteria for OA of the knee or hip;\[14,15\]
* being in the age range 18-65; and
* absence of other diseases affecting functions and daily life (orthopedic, neurological, cardiovascular, metabolic disease and lung pathology).

Exclusion Criteria:

* comorbidity affecting lower extremity and functions (patellofemoral pain syndrome, rheumatoid arthritis, ligament tear, meniscus);
* previous lower extremity surgery;
* Intra-articular steroid or hyaluronic acid injection in the last three months
* cognitive impairments;
* pregnancy; and
* illiteracy.

Primary outcomes:
measure: The Western Ontario and McMaster Universities (WOMAC) OA Index:
timeFrame: 15 min
measure: Nottingham Health Profile (NHP):
timeFrame: 15 min
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University School of Physical Therapy and Rehabilitation
Study officials:
References:
Clinical trial NCT01727310: Filling Pressures of the Left Ventricle in Patients With Significant Aortic Stenosis
Official title: Filling Pressures of the Left Ventricle in Patients With Significant Aortic Stenosis: Study of Echocardiographic Parameters Compared to Invasive Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Valvular Disease
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2012-11-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of both gender hospitalized for a coarctation review, and has received or will be receiving during their stay a complete echocardiography and coronary angiography, and left and right catheterization .

Brief summary: Left valvular heart disease has become one of the most common heart disease in Western countries. This disease evolve over many years and are characterized by a long phase where the patient is "asymptomatic".

it is characterized by discomfort LV filling may worsen and lead typically to a pressure increase of LV pressure and the left atrium (LA) (1). The onset of symptoms is unpredictable and may occur at the stage of diastolic or systolic dysfunction.

Ventricular dysfunction may be insidious, the goal is to detect early dysfunction, knowing that it is often very difficult to know if the patient is actually symptomatic. The onset of symptoms sign an intolerance to the increase in LV filling pressures and LA , causing pulmonary hypertension .

Therefore, the study of the level of LV and LA filling pressures , if possible by a noninvasive method, would identify patients apparently asymptomatic even though their condition is advanced.

Pressures filling pressures can be explored by two methods:

* cardiac catheterization, which is a direct and invasive measurement method
* echocardiography, which is an indirect measurement method which has the advantage of being non-invasive The goal of this research is to compare the two methods.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years;
* Patients hospitalized for a coarctation review, and has received or will be receiving during their stay a complete echocardiography and coronary angiography, and left and right catheterization

Exclusion Criteria:

* Pregnant women
* Patients with a history of valve replacement surgery,
* Patients with other valvular\> grade 2 associated with the coarctation
* Patients known to have ischemic heart disease or in whom angiography showed significant coronary artery disease;
* Patients with chronic or paroxysmal atrial fibrillation
* Patients with a permanently pacemaker

Primary outcomes:
measure: quality of echocardiography
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: Departement de Cardiologie
city: Montpellier
country: France
facility: Departement de Cardiologie
Study officials:
References:
Clinical trial NCT04128410: A Study on Central Transport Characteristics of Flurbiprofen Axetil in Elderly Patients
Official title: A Study on Central Transport Characteristics of Flurbiprofen Axetil in Elderly Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Flurbiprofen Axetil
Cerebrospinal Fluid
Anesthesia, Spinal
Aged
Keywords: S-flurbiprofen, R-flurbiprofen
cerebrospinal fluid
aged
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ASA I or lII, both sexes, aged 18-85 yr

Brief summary: The project will apply the methods of clinical observation experiment to study the central transport characteristics of flurbiprofen axetil by detecting S-flurbiprofen and R-flurbiprofen concentrations in cerebral-spinal fluid(CSF) after intravenous injection of flurbiprofen axetil in elderly patients.

Detailed description: The patients undergoing spinal anesthesia for lower extremity surgery will be studied. Flurbiprofen axetil 100mg will be injected intravenously. CSF 1ml and blood 2ml will be obtained simultaneously every 5 minutes after intravenous injection in 50 min( T1\~T10).CSF and blood samples will be used to detected S-flurbiprofen and R-flurbiprofen concentrations by using Liquid Chromatography-Mass Spectrometry. And the CSF/blood S-flurbiprofen and R-flurbiprofen concentrations ratio were calculated.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing lower extremity surgery under spinal or combined spinal-epidural anesthesia will be selected.

Exclusion Criteria:

* asthma, liver insufficiency, renal insufficiency, peptic ulcer, allergy to NSAIDs, and a history use of NSAIDs within two weeks before operation.

Primary outcomes:
measure: The concentrations of S-flurbiprofen and R-flurbiprofen in plasma and CSF of all patients.
timeFrame: perioperation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Yi Feng, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01490710: NAVADYN11 : Hemodynamic Impact of a New Ventilatory Support Mode With Diaphragmatic Synchronization
Official title: NAVADYN11 : Hemodynamic Impact of a New Ventilatory Support Mode With Diaphragmatic Synchronization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Invasive Ventilatory Support
Keywords: NAVA
Hemodynamic
Cardiac Index
Children with admission weight > 5kg
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2011-12-13
Enrollment: 9
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Despite spectacular advances since the 90s mechanical ventilation used in intensive care units are amply associated with cardio-respiratory complications: nosocomial pneumonia, lung parenchyma lesions induced by ventilation, hemodynamic instability and ultimately to a significant morbidity and mortality.

NAVA (Neurally Adjusted Assist Ventilation) ventilatory support, provides synchronous support, proportionate to patient's respiratory efforts. More "physiological", this mode would decline its efficacy on patient hemodynamic response. However, to date, no study has focused on hemodynamic impact of NAVA. This is precisely the purpose of NAVADYN11 study, which aims to assess NAVA efficacy on cardiac index in pediatric intensive care unit.


Eligibility criteria: Inclusion criteria:

* Servo-i with NAVA available at patient admission
* Sedation protocol compatible with NAVA functioning
* Parental consent

Non inclusion criteria:

* Digestive pathology incompatible with gastric tube.
* Deep sedation required defined by score ComfortB \<11 (cranial traumatism...)
* Brain damage incompatible with spontaneous ventilation
* Duration of intubation too short for investigation

Exclusion criteria:

* Clinical worsening requiring treatment and/or management inconsistent with NAVADYN11 research (CPR, emergency surgery ...). However, the investigator is allowed to reiterate investigation when patient stabilized.

Primary outcomes:
measure: Assess the impact of NAVA ventilation on hemodynamic parameters
Secondary outcomes:
measure: Omega score
measure: Heart rate
measure: Blood pressure
measure: NIRS
measure: Blood gas
measure: Lactate
measure: BNP
measure: Perfusion score
measure: Right cardiac work index
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Nicolas JORAM, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liet JM, Barriere F, Gaillard-Le Roux B, Bourgoin P, Legrand A, Joram N. Physiological effects of invasive ventilation with neurally adjusted ventilatory assist (NAVA) in a crossover study. BMC Pediatr. 2016 Nov 8;16(1):180. doi: 10.1186/s12887-016-0717-4.
Clinical trial NCT00011310: Cardiopulmonary Effects of Particulate Exposure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Tract Diseases
Cardiac Diseases
Bronchitis
Keywords: Particulates
Air Pollution
Cardiopulmonary Disease
Lung
Inflammation
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-02-19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The aim of this study is to assess cardiac rate and respiratory responses and rhythm after workplace exposure to combustion particulates. A repeated measurement study is being performed on acute boilermakers (apprentices and journeymen). A stratified analysis is then done on those with and without chronic bronchitis, after adjustment for relevant covariates.

Detailed description: Population-based epidemiologic studies of communities in the United States have revealed a consistent association between ambient particulate air pollution and increases in morbidity and mortality. The observed increases result from both respiratory and cardiovascular diseases. Similar associations have been observed for rates of hospital admissions for respiratory and cardiovascular diseases for subjects over age 65. These ambient exposures are to low levels of particulates, many times lower than occupational exposures faced by workers in a variety of industries, including manufacturing, construction, transportation and electric-power generation. The objective of this proposal is to investigate the role of occupational exposure to particulates in the development of respiratory and cardiac responses in boilermakers. We will employ a detailed, continuous-exposure assessment to PM2.5 with repeated measures of biologic and physiologic markers of response. Specific hypotheses to be tested will include: (1) occupational exposure to fuel-oil ash particulates induce airway inflammation as reflected in increased expired NO, and airflow obstruction as reflected in decreases in peak flow (PEFR) and FEV1; (2) particulate exposure will result in acute changes in cardiovascular function, as reflected in changes in heart rate, heart-rate variability and blood pressure; (3) particulate exposures result in increased serum fibrinogen levels, a known risk factor for cardiovascular disease; and (4) chronic bronchitis predisposes particulate-exposed workers to changes in cardiac function. The results of this study will have important implications for preventive efforts aimed at reducing morbidity and mortality from occupational exposure to respirable particulates.

Eligibility criteria: Adults; Over 18; Boilermakers

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard School of Public Health
state: Massachusetts
Study officials:
References:
Clinical trial NCT04485910: PGTai Results for Embryos Cultured in Sequential Versus Single Step Media
Official title: Sequential Versus Single Step Culture Media in Relation to Euploidy Rates in PGTai Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Aneuploidy Rate
Mosaicism
Keywords: PGT-A
Mosaicism
Single step media
Sequential media
Lead sponsor: Ganin Fertility Center
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Evaluating the embryonic development and PGTai results for embryos cultured in sequential media versus single step media.
Primary purpose: OTHER

Brief summary: A prospective cohort study undergoing ICSI at a private fertility center in Egypt

Detailed description: Purpose:

To evaluate PGTai results for embryos cultured in sequential versus single step media.

Method:

Injected oocytes will divided between Continuous Single Culture-NX media (CSC- NX) with 10% SSS the first group (Irvine, USA) and the other group will be cultured in sequential cleavage and blastocyst media with 10% SPS (SAGE, Denmark).

All blastocytes with 4BB quality and better according to Gardner's criteria 1999 will go through PGTA procedures with PGTai confirmation.

Eligibility criteria: Inclusion Criteria:

* Female age ≤37 years with ≥ 8 mature oocytes
* Male partner had normal semen parameters according to WHO 2010
* PGT-A was done at the blastocyst stage

Exclusion Criteria:

* sperm or oocyte donor
* severe male factors according to WHO 2010

Primary outcomes:
measure: Euploidy rate
timeFrame: 5:7 days of intracytoplasmic sperm injection(ICSI)
measure: Mosaicism rate
timeFrame: 5:7 days of ICSI
Secondary outcomes:
measure: Fertilization rate
timeFrame: 16:19 hours of ICSI
measure: Cleavage stage
timeFrame: 72 hours of ICSI
measure: High quality of cleaved embryos
timeFrame: 72 hours of ICSI
measure: Blast formation rate
timeFrame: 5:7 days of ICSI
measure: High quality blast rate
timeFrame: 5:7 days of ICSI
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ganin Fertility Center
Study officials:
affiliation: Ganin Fertility Center
name: Manar M Hozyen, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Amr Elshimy, BSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hanaa Elkhader, BSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hosam Zaki, MSc.
role: STUDY_CHAIR
References:
Clinical trial NCT03708510: Clinical Evaluation of Two Low-shrinkage Composites
Official title: Clinical Evaluation of Two Low-shrinkage Composites After Different Preparation Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Diseases
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with 4 occlusal lesions in molar teeth will be included. Occlusal cavities will be prepared either by Er,Cr:YSGG laser (LS) or conventional diamond bur (BR). Cavities will be restored with Filtek Silorane (3M-ESPE) (SR) and with Kalore (GC) (KR) according to the manufacturers' instructions. All restorative procedures will be performed by one operator and the restorations will be examined by two evaluators according to the FDI (World Dental Federation) criteria at baseline and at 6-month, 1-, 2-,3-, 4-, 5-, 6-, 7-, 8-, 9-, 10-year. Patients' satisfaction about the preparation methods will be evaluated with a survey. Pearson Chi-Square test will be used for statistical analyze(p=0.05).


Eligibility criteria: Inclusion Criteria:

1. age range will be 18 to 60
2. patients should have at least 4 occlusal caries lesions require restoration
3. healty periodontal status
4. a good likelihood of recall availability

Exclusion Criteria:

1. poor gingival health
2. adverse medical history
3. potential behavioral problems

Primary outcomes:
measure: Clinical performance of different low-shrinkage composites and preparations
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00840710: Clinical Feasibility of Birth- Track II System
Official title: Clinical Feasibility of Birth- Track II System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstetrics
Labor
Keywords: women in active labor
Lead sponsor: Barnev Ltd
Sponsor class: OTHER
First posted: 2009-02-10
Enrollment: 15
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in active labor

Brief summary: The Study purpose is to monitor the cervix dilation, head descent, FHR and to follow contraction in a women in active labor.


Eligibility criteria: Inclusion Criteria:

1. Laboring women referred to the Maternity Center in active labor (3cm dilatation and contractions).
2. Gestational age 37-42 weeks. (GA)
3. Single fetus
4. Subjects who understood, agreed and signed the informed consent form

Exclusion Criteria:

1. Women with abnormal placentation (placenta previa)
2. Abnormal fetal presentation (breech presentation)
3. Maternal History of HIV and/or blood transmitted hepatitis and/or active genital Herpes.
4. Need for immediate delivery (cord prolapsed or suspected placental abruption)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Westren Gallilie Hospital
Study officials:
affiliation: Westren Gallilie Hospital
name: Jacob Bornstein, PhD
role: PRINCIPAL_INVESTIGATOR
References: