louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02326051: Timing of Initiation of LMWH Administration in Pregnant Women With APS
Official title: Timing of Initiation of Low Molecular Weight Heparin Administration in Pregnant Women With Antiphospholipid Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Recurrent Miscarriage
Antiphospholipid Syndrome
Keywords: Antiphospholipid syndrome
APS
LMWH
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2014-12-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluation of the effect of altering the timing of initiation of low molecular weight heparin (LMWH) administration on the pregnancy outcomes in women with antiphospholipid syndrome (APS)

Detailed description: Women will be randomly divided into two groups; one will start Enoxaparin therapy once positive pregnancy test is established and the other will start Enoxaparin therapy after sonographic confirmation of fetal cardiac pulsation. In all women, Enoxaparin will be given in a dose of 40 mg/day subcutaneously and the therapy will continue until termination of pregnancy

Eligibility criteria: Inclusion Criteria:

* Pregnant women with APS diagnosed according to the revised classification criteria for APS in 2006 in Sydney, Australia
* Early pregnancy body weight is 50-90 Kg

Exclusion Criteria:

* Women with systemic lupus erythematosus (SLE)
* Women with active thromboembolic disorders
* Women with history of previous thromboembolic disorders

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: After 12 weeks gestational age
Secondary outcomes:
measure: Fetal loss
timeFrame: From 20 weeks to 42 weeks gestational age
measure: Preterm delivery
timeFrame: From 20 weeks to 34 weeks gestational age
measure: Intrauterine growth restriction (IUGR)
timeFrame: At birth
measure: Congenital fetal malformations
timeFrame: At birth
Other outcomes:
measure: Hemorrhagic complications
timeFrame: After 12 weeks gestational age up to birth
measure: Thromboembolic complications
timeFrame: After 12 weeks gestational age up to birth
Locations:
city: Mansourah
country: Egypt
facility: Obstetrics and Gynecology Department in Mansoura University Hospital
state: Dakahlia
city: Mansourah
country: Egypt
facility: Private practice settings
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Mohamed I Eid, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Mohamed S Abdelhafez, Dr
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Waleed El-refaie, Dr
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Ahmed El-Zayadi, Dr
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Ahmed Badawy, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT06233851: BLOOD BIOMARKERS in PAEDIATRIC MTBI
Official title: Prospective Paediatric Cohort Study of Biomarkers in the Early Management of Mild Traumatic Brain Injury and Prediction of Persistent Post-concussion Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mild Traumatic Brain Injury
Lead sponsor: Pediatric Clinical Research Platform
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 600
Sex: ALL
Minimum age (years): 0
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: paediatric patient suffering from a mild TBI within 24 hours

Brief summary: The goal of this observational study is to identify blood biomarkers that could help in the management of paediatric patients with mild TBI. The main questions it aims to answer are:

1. How can blood biomarkers reduce unnecessary CT scan and reduce the length of stay at the emergency department?
2. How can blood biomarker predict post-concussion symptoms?

Participants will have a blood sample taken when they are admitted at emergency department and will receive a questionnaire describing their symptoms 14 days and 3 months after their trauma.

Detailed description: Mild Traumatic Brain Injury (mTBI) in children is a very frequent reason for presentation at the paediatric emergency department. In most cases, the trauma will not lead to intracranial lesions. The first objective for clinicians is therefore to detect all children in need of neurosurgical intervention after mTBI. Although computerized tomography (CT) is currently the modality of choice for acute intracranial haemorrhage identification, care should be taken to avoid unnecessary exposure to ionizing radiation in the developing brain. Monitoring the occurrence of bleeding usually involves an observation period which generally extends from six to twenty-four hours. This time is stressful for the child and parents as well as time and cost consuming for the hospital. In addition to the acute conditions, it has been described that post-concussion symptoms can occur in the weeks or months following the trauma, and neuropsychological follow-up of these children could help prevent or reduce the symptoms. The aim of our study is to find biomarkers that can identify children with clinically important intracranial injury and/or children that will eventually suffer from a post-concussion syndrome.

Eligibility criteria: Inclusion Criteria:

* mTBI within 24 hours

Exclusion Criteria:

* refusal of child or parents
* evidence of intoxication with alcohol or other substances
* history of TBI ( less than one month)
* epilepsy, encephalitis, meningitis, melanoma

Primary outcomes:
measure: intracranial injuries on CT scan
timeFrame: Admission; within 24 hours
measure: Post concussion symptoms
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Geneve
country: Switzerland
facility: HUG
Study officials:
affiliation: University Hospital, Geneva
name: Sergio Manzano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04043351: Diagnostic Performance of Exome Sequencing in Autism Spectrum Disorders
Official title: Diagnostic Performance of Exome Sequencing in Autism Spectrum Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with Autism Spectrum Disorder (ASD)

Brief summary: Evaluation of the diagnostic performance of exome sequencing in a prospective series of patients with autism spectrum disorders (ASD).


Eligibility criteria: Inclusion Criteria:

* Patient with ASD who has been previously diagnosed by an expert center according to the DSM5 criteria using standardized instruments (ADOS, ADI-R), referred to genetic consultation by the psychiatrist who performed the clinical diagnosis, according to the recommendations of the HAS, and requesting a genetic analysis for medical purposes in this context.
* Patient over 3 years old
* Patient affiliated to a social security scheme
* For minor patients: Holders of the exercise of parental authority who have read and understood the newsletter and signed the consent form
* For a major patient: Major patient who has read and understood the newsletter and signed the consent form
* Supervised minor / minor patient: Legal representative who has read and understood the newsletter and signed the consent form
* Major patient under guardianship: Major patient assisted by his curator or by the judge having read and understood the newsletter and signed the consent form
* DNA of the patient and parents available

Exclusion Criteria:

* Patient who has already benefited from exome sequencing
* Person deprived of liberty by an administrative or judicial decision
* Pregnant or lactating woman

Primary outcomes:
measure: Proportion of unrelated index cases
timeFrame: through study completion, an average of 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: DRCI
Study officials:
affiliation: ROUEN HOSPITAL
name: GAEL NICOLAS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04872751: Immune Response of Haemodialysis Patients Post Covid-19 Vaccination
Official title: The Malaysian Study On Hemodialysis Patients SARS-COV-2 Vaccination Immune Response: A Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immune Response Post Covid 19 Vaccination
Lead sponsor: Penang Hospital, Malaysia
Sponsor class: OTHER_GOV
First posted: 2021-05-04
Enrollment: 425
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 with end-stage renal failure (ESRF) receiving hemodialysis

Brief summary: The purpose of this study is to assess immune response of end stage renal failure patients after Covid 19 vaccination


Eligibility criteria: Inclusion Criteria:

* ESRF patient on hemodialysis who are eligible for the goverment Covid 19 vaccination programme
* 18 years old and above
* consented to join the study

Exclusion Criteria:

* patient who refused to be vaccinated
* patient who deemed unsuitable for Covid vaccination

Primary outcomes:
measure: Change From Baseline in post vaccination SARS-CoV-2 neutralizing antibody level
timeFrame: up to one year
Secondary outcomes:
measure: Change From Baseline in post vaccination SARS-CoV-2 neutralizing antibody level after 1st inoculation of the vaccine (incomplete vaccination)
timeFrame: one month
Other outcomes:
Locations:
city: George Town
country: Malaysia
facility: Penang Hospital
state: Penang
Study officials:
affiliation: Penang Hospital
name: LokeMeng Ong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06181851: 2015-Metabolomics&Microbiome-infertility
Official title: Microbiome and Metabolomics Analysis in a Population of Infertile Patients Suffering From Non-obstructive Azospermia and Examination of Their Impact on the Reproductive Potential and Global Health of the Individual
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Azoospermia, Nonobstructive
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * diagnosis of idiopathic non-obstructive azoospermia
* fertile men (pregnancy within 12 months from the start of the couple's search)
* men known to have been fertile aged between 65 and 75 (pregnancy within 12 months of the couple starting searching)

Brief summary: The study aims to carry out a translational analysis of the microbiome and metabolomics in patients suffering from non-obstructive azoospermia, with the aim of investigating prognostic factors predictive of the possible finding of spermatozoa following testicular pulp extraction and differences in blood and seminal level with the fertile population to identify etiopathogenic pathways of this condition.

Detailed description: The study aims to carry out a translational analysis of the microbiome and metabolomics in patients suffering from non-obstructive azoospermia, with the aim of investigating prognostic factors predictive of the possible finding of spermatozoa following testicular pulp extraction and differences in blood and seminal level with the fertile population to identify etiopathogenic pathways of this condition.

Furthermore, the study aims to assess if the blood and seminal alterations of infertile patients have similarities with the same fluids of elderly patients, validating from a metabolomic and microbiomic point of view the hypothesis of premature aging of infertile patients.

Eligibility criteria: Inclusion Criteria:

* diagnosis of idiopathic non-obstructive azoospermia
* fertile men (pregnancy within 12 months from the start of the couple's search)
* men known to have been fertile aged between 65 and 75 (pregnancy within 12 months of the couple starting searching)

Exclusion Criteria:

* diagnosis of varicocele
* endocrine alterations
* chromosomal alterations
* known genetic alterations

Primary outcomes:
measure: Prognostic role of the blood and semen samples
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
state: Lombardy
Study officials:
References:
Clinical trial NCT04780451: Omega-3 Supplementation Combined With Endurance Training Improve Running Economy in Recreational Runners.
Official title: 12 Weeks of Omega-3 Supplementation Combined With Endurance Training Improve Running Economy in Recreational Runners. The Potential Role of the Myokines-NO Pathway.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Effect of Omega-3 Supplementation on Exercise Performance and Muscle Tissue Functions
Keywords: omega-3
supplementation
endurance training
running
Lead sponsor: Gdansk University of Physical Education and Sport
Sponsor class: OTHER
Collaborators: name: Medical University of Gdansk
name: University of Southampton
First posted: 2021-03-03
Enrollment: 40
Sex: MALE
Minimum age (years): 29
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Recreational male runners participated in 12 weeks training and omega-3 supplementation programme. Before starting and at the end of the 12-week cycle, the runners performed an increasing intensity treadmill test where oxygen uptake and VO2 peak were assessed.

Detailed description: 40 healthy, recreational male runners participated in 12 weeks training and supplementation programme. The training protocol was built based on undulatory load manipulation 3:1, which was suggested to be effective to prevent overtraining and stress due to oscillations between volume/intensity. Throughout the study all participants took 4 identical-looking capsules per day (2 in the morning and 2 in the evening) containing either omega-3 fatty acids or medium chain triglycerides as placebo in total amount of 4g of fat per day. Before starting and at the end of the 12-week cycle, the runners performed an increasing intensity treadmill test where oxygen uptake and VO2 peak were assessed. Additionally, blood was collected to determine the concentrations of selected proteins (including eNOS, irisin, adiponectin) that may be associated with potential changes in participants' oxygen uptake during the treadmill test.

Eligibility criteria: Inclusion Criteria:

* non smoking
* no chronic diseases
* no supplements and medicines
* personal best in 10km run between 35 and 59 min at the turn of 2016 and 2020 y

Exclusion Criteria:

-

Primary outcomes:
measure: changes in oxygen consumption during running test
timeFrame: between 10 and 25 minutes of the running test
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Gdansk University of Physical Education and Sport
Study officials:
References:
Clinical trial NCT03875651: A Clinical Trial to Confirm Safety & Effectiveness of the SYNERGY 4.50 mm and 5.00 mm Stent for Treatment of Atherosclerotic Lesion(s)
Official title: A U.S. Post-Approval Study of the SYNERGY 4.50/5.00 mm Everolimus-Eluting Platinum Chromium Coronary Stent System (Evolve 4.5/5.0)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Heart Diseases, Coronary
Coronary Artery Disease
Cardiovascular Diseases
Keywords: Drug-Eluting Stents
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2019-03-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eligible patients include those with atherosclerotic coronary lesions with vessel diameters that can appropriately be treated with 4.50 mm and/or 5.00 mm stents according to the commercially approved SYNERGY DFU

Brief summary: EVOLVE 4.5/5.0 is a prospective, single-arm, multi-center observational (standard of care) trial intended to confirm the safety and effectiveness of the SYNERGY 4.50 mm and 5.00 mm Coronary Stent System for the treatment of patients with coronary artery disease in large vessels (≤ 28 mm in length, by visual estimate, in native coronary arteries \> 4.00 mm to ≤5.00 mm in diameter, by visual estimate). This Post Approval study is a cohort associated with the SYNERGY MEGATRON Post Approval Study, which is registered under ClinicalTrials.gov ID: NCT04807439.


Eligibility criteria: Inclusion Criteria:

* A patient is an acceptable candidate if they require treatment with a 4.50 or 5.00 mm SYNERGY stent for the treatment of their disease in accordance with the applicable guidelines on PCI, the SYNERGY DFU, and the Declaration of Helsinki.

Exclusion Criteria:

* Planned treatment with a non-SYNERGY stent.

Primary outcomes:
measure: Target Lesion Failure (TLF) rate
timeFrame: 12-months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Boston
country: United States
facility: Beth Israel Deaconness Medical Center
state: Massachusetts
city: Kansas City
country: United States
facility: North Kansas City Hospital
state: Missouri
city: Raleigh
country: United States
facility: Wake Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Lindner Center for Research and Education at Christ Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health Science University
state: Oregon
city: Dallas
country: United States
facility: Baylor Heart and Vascular Hospital
state: Texas
city: Fairfax
country: United States
facility: Inova Fairfax Hospital
state: Virginia
Study officials:
affiliation: Baylor Heart and Vascular Hospital
name: Robert C Stoler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03971851: Validation of a Novel Frailty Index in Surgical Cohorts
Official title: Testing and Validation of a Novel Frailty Index in a Surgical Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery--Complications
Anesthesia Morbidity
Perioperative Complication
Lead sponsor: University of Iceland
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 50000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals over 65 years of age undergoing surgery at a University Hospital Setting

Brief summary: This study will validate the utility of a novel frailty index that uses ICD diagnoses to call frailty severity in a surgical cohort of patients 65 and older


Eligibility criteria: Inclusion Criteria:

* Patients 65 years or older, undergoing any surgery at Landspitali University Hospital with an anesthesia team involved

Exclusion Criteria:

* No American Society of Anesthesiology classification provided

Primary outcomes:
measure: 30-day mortality
timeFrame: 30-days
measure: Time to hospital readmission
timeFrame: Up to 180 days
Secondary outcomes:
measure: Long-term mortality
timeFrame: Up to 14 years
measure: Prolonged hospital length-of stay
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Iceland
name: Martin I Sigurdsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03169751: An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures
Official title: An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Epileptic Seizure
Motor Seizure
Epilepsy
Lead sponsor: Brain Sentinel
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People with a suspected history of Psychogenic Non Epileptic Seizures with upper extremity motor involvement. and/or Epileptic Seizures with upper extremity motor involvement

Brief summary: This is an observational study of subjects receiving standard of care therapy, while admitted to Epilepsy Monitoring Unit, Department of Neurology, General Hospital Hietzing with Neurological Center Rosenhügel. Additional monitoring provided by the SPEAC System will be compared to the gold standard, vEEG. The SPEAC System is being evaluated while being used in adjunct to standard of care.


Eligibility criteria: Inclusion Criteria:

1. Subject has a suspected history of PNES with upper extremity motor involvement or epileptic seizures with upper extremity motor involvement.
2. Is being admitted to a hospital for routine vEEG monitoring related to seizures.
3. Male or female between the ages of 18-99.
4. If female and of childbearing potential, has a negative pregnancy test.
5. Can understand and sign written informed consent prior to the performance of any study assessments.
6. Subject must be competent to follow all study procedures.

Exclusion Criteria:

1.Intracranial EEG electrodes are being used.

Primary outcomes:
measure: 3 independent physicians' abilities to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using vEEG, using a majority rules approach (2 out of 3)
timeFrame: 5 days
measure: 3 independent physicians' abilities to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using sEMG, using a majority rules approach (2 out of 3)
timeFrame: 5 days
Secondary outcomes:
measure: To evaluate the System's ability to detect GTC seizures, as compared to vEEG monitoring
timeFrame: 5 days
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel
Study officials:
affiliation: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
name: Christoph Baumgartner, MD
role: PRINCIPAL_INVESTIGATOR
References: