louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03475784: Two Fluid Strategies for Prevention of Post-dural Puncture Headache
Official title: Comparison of Two Fluid Strategies for Prevention of Post-dural Puncture Headache After Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Dural Puncture Headache
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 100
Sex: FEMALE
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: Postdural puncture headache (PDPH) is a common complication after cesarean delivery (CD). The role of peri-operative fluid therapy in prophylaxis against PDPH is unclear. The aim of this work is to compare restrictive versus liberal fluid therapy in prophylaxis against PDPH after CD

Detailed description: In this study, the investigators will compare restrictive fluid therapy and liberal fluid therapy in prophylaxis against postdural puncture headache.

The restrictive group will not receive preoperative fluid loading, and will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 2 mL/Kg/hour for hours. The Liberal group will receive preoperative fluid loading of 5 mL/Kg, and will receive intraoperative crystalloids at rate of 10 mL/Kg/hour, followed by postoperative crystalloids at rate of 6 mL/Kg/hour.

Both groups will be compared regarding demographic data, total peri-operative fluids, incidence of postdural puncture headache, nausea, vomiting, and intraoperative hemodynamics (heart rate and systolic blood pressure) in addition to neonatal outcomes.

Eligibility criteria: Inclusion Criteria:

* Full term
* Pregnant female
* Scheduled to elective cesarean delivery

Exclusion Criteria:

* History of migraine headache
* Hypertensive disorders of pregnancy
* Cardiac morbidities,
* Baseline systolic blood pressure \< 100 mmHg
* Contraindication of regional anesthesia.
* Patients with more than one single attempt for spinal block

Primary outcomes:
measure: Incidence of post-dural puncture headache
timeFrame: 48 hours
Secondary outcomes:
measure: incidence of post-spinal hypotension
timeFrame: 60 minutes
measure: Wong-Baker faces pain scale
timeFrame: 48 hours
measure: heart rate
timeFrame: 24 hours
measure: postoperative nausea and vomiting
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Head of obstetric anesthesia section in anesthesia department
name: Tarek Abdelbarr, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06906484: Systematic Transthoracic Echocardiographic Screening in Amateur Football Referees
Official title: Diagnostic Value of Systematic Echocardiography in the Cardiovascular Screening of Amateur Football Referees
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Sreening
Soccer Referees
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes amateur football referees affiliated with the Normandy Football League (France) who actively officiated since the 2022 season.

Brief summary: This retrospective study aims to evaluate the prevalence of cardiac abnormalities detected by transthoracic echocardiography (TTE) in amateur football referees as part of a systematic cardiovascular screening program.

Detailed description: cardiovasculaire screening of athletes and sports officials is essential for preventing sudden cardiac death during physical activity. In 2019, the French Football Federation (FFF) introduced mandatory transthoracic echocardiography (TTE) for amateur referees over 18 years old, to improve early detection of cardiovascular abnormalities.

This retrospective observational study investigates the diagnostic value of systematic TTE in detecting structural or functional cardiac anomalies among adult amateur referees affiliated with the Normandy Football League.

The primary objective is to estimate the prevalence of cardiac abnormalities diagnosed by TTE in this population. The secondary objectives include identifying the prevalence of cardiovascular risk factors (CVRFs), and describing the abnormalities found during the medical evaluation

Eligibility criteria: Inclusion Criteria:

Male amateur football referees, aged ≥18 Affiliated with the Normandy Football League Completed a baseline TTE No known pre-existing cardiac disease Complete medical records available

Exclusion Criteria:

Referees under 18 or in training status History of cardiovascular disease Incomplete medical file

Primary outcomes:
measure: Prevalence of structural or functional abnormalities detected by TTE
timeFrame: At the baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU de CAEN
state: Normandie
Study officials:
References:
Clinical trial NCT01976884: Expression and the Clinical Significance of Neutrophil PD-L1 During Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Immunosuppression
Keywords: sepsis
immunosuppression
PD-L1
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2013-11-06
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted in ICU at Changhai Hospital

Brief summary: Immunosuppression is the leading cause of death in septic patients. Neutrophils are classical components of innate immunology, but recent studies showed that neutrophils might display antigen presenting function and inhibit lymphocyte proliferation by expressing programmed cell death 1 ligand 1 (PD-L1). Whether neutrophils express PD-L1 and its role in immunosuppression during sepsis remain unclear.


Eligibility criteria: Inclusion Criteria:

* patients with severe sepsis
* patients with sepsis after PCNL for infectious kidney stone
* patients with pancreatic cancer
* healthy volunteers

Exclusion Criteria:

* patients with immunodeficient diseases
* patients who accept glucocorticoid or immunosuppressant
* patients with an age older than 18 years
* patients providing the informed consent

Primary outcomes:
measure: PD-L1 level on neutrophils
timeFrame: within 24h after recruitment
Secondary outcomes:
measure: 28-day mortality
timeFrame: 28 days after diagnosis of sepsis
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00011284: Mechanisms of Inflammatory Liver Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Diseases
Keywords: Liver
Inflammation
Endotoxin
Neutrophils
Hepatocytes
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-02-19
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: White blood cells can cause liver damage if they inappropriately accumulate in the liver in large numbers. Such an event can occur if an individual's blood is exposed to endotoxin, a substance released from the cell walls of many species of bacteria. The purpose of this study is to isolate neutrophils, an important white blood cell, from the blood of normal volunteers, and put them in tissue culture with isolated liver cells. The experiments will determine how endotoxin can increase the ability of neutrophils to damage liver cells. All studies supported by this grant will be done with isolated cells in tissue culture. This experimental model will reveal possible mechanisms that can in the future be evaluated in human diseases such as bacterial sepsis.

Detailed description: Neutrophils will be isolated from normal human volunteers and placed in cell culture with isolated hepatocytes or C3A cells (hepatoblastoma cell line that exhibit many characteristics of normal hepatocytes). These experiments will evaluate the mechanisms by which neutrophil adhere to the surface of hepatocytes, and the mechanisms by which the attached neutrophils can damage or kill the hepatocytes. Mechanisms of adhesion will involve understanding of the chemokines released by the hepatocytes that stimulate neutrophil adhesiveness, the cytokines that activate hepatocytes to express chemokines and adhesion molecules, the adhesion receptors on the neutrophil surface that are able to recognize the adhesion molecules on the hepatocyte surface, and the ability of adhesion to enhance and focus cytotoxic chemicals coming from the stimulated neutrophils. In addition, the role endotoxin can play in these sequence of events is being studies, and the specific cytotoxic mechanisms released by the neutrophils are under study. As noted in the brief summary, this grant only supports use of human cells in vitro (i.e., all experiments will be done in tissue culture). The purpose of working with this experimental model is to define what mechanisms should in future experiments be evaluated in patients with endotoxin induced disease.

Eligibility criteria: Only blood from normal subjects will be used in the in vitro experiments.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References:
Clinical trial NCT05884684: What is the Potential Impact of Reviewing Post-procedure Images With Patients Following Interventional Spine Procedures.
Official title: What is the Potential Impact of Reviewing Post-procedure Images With Patients Following Interventional Spine Procedures.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Patient Satisfaction
Keywords: Epidural
Spine procedure
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A spine physician will not discuss images with the first group of participants immediately following their procedure. A spine physician will discuss images with the second group of participants immediately following their procedure.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to explore the impact of spine physicians reviewing post-procedural fluoroscopic images with patients. The outcome measure to be assessed will be the potential impact the patient satisfaction and the patient's global impression of change (PGIC) 2 weeks after the spine procedure.


Eligibility criteria: Inclusion Criteria:

* Lumbosacral radiculopathy symptoms
* Received transforaminal epidural steroid injection

Exclusion Criteria:

* Patients who will be sedated for transforaminal epidural steroid injection
* Unable to read or understand English-language survey

Primary outcomes:
measure: Modified Press Gainey Satisfaction (PGS) Questionnaire
timeFrame: Up to 2 hours following procedure in the post-op area
Secondary outcomes:
measure: Patient Global Impression of Change (PGIC)
timeFrame: 2 weeks following procedure
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan - Burlington Building
state: Michigan
Study officials:
affiliation: University of Michigan
name: David Kohns, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06868784: Investigation of the Relationship Between Executive Functions and Occupational Performance of Children with Duchenne Muscular Dystrophy
Official title: Investigation of the Relationship Between Executive Functions and Occupational Performance of Children with Duchenne Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Executive Dysfunction
Occupational Problems
Duchenne Muscular Dystrophy
Lead sponsor: Lokman Hekim Üniversitesi
Sponsor class: OTHER_GOV
First posted: 2025-03-11
Enrollment: 38
Sex: MALE
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All boys diagnosed with DMD between the ages of 6-12 years constitute the population of this study.

Brief summary: The effects of Duchenne muscular dystrophy and its treatments on executive functions and occupational performance are under-mentioned in the literature. The researches believe that developmental and cognitive research is needed to identify interventions for children with DMD to identify and adapt to both individual and social environments, including self-care, productivity and leisure activities. Therefore, the aim of this study was to examine executive functions and occupational performance in children with DMD and compare them with healthy controls.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with DMD
* Volunteering to participate in the study by their parents and reading and signing the informed consent form

Exclusion Criteria:

* Having a neuromuscular disease other than DMD and/or another diagnosed neuromuscular disease accompanying DMD
* The family and/or the child has problems with cooperation in completing the assessments for any reason
* Difficulty understanding and speaking the Turkish language

Primary outcomes:
measure: Demographic information form
timeFrame: one-time evaluation
measure: Brooke upper extremity functional scale
timeFrame: one-time evaluation
measure: Vignos lower extremity functional scale
timeFrame: one-time evaluation
measure: The Childhood Executive Functioning Inventory
timeFrame: one-time evaluation
measure: Canadian Occupational Performance Measure
timeFrame: one-time evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Lokman Hekim University
state: Çankaya
Study officials:
References:
Clinical trial NCT03140384: Compare the Different Routes of Administration of Misoprostol During Medicinal Abortion Between 7 and 9 Weeks of Amenorrhoea (SA)
Official title: Compare the Different Routes of Administration of Misoprostol During Medicinal Abortion Between 7 and 9 Weeks of Amenorrhoea (SA)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Misoprostol
Drug-induced Abortion
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In France, drug-induced abortion is allowed up to 9SA, after which the surgical route is preferred. Mifepristone 600mg is used 36-48 hours before the introduction of Misoprostol. This is recommended orally at a dose of 400 μg. There are currently several studies on the subject, including a meta-analysis of the 2011 Cochrane Database, but doses, routes of administration and gestational age differ in all studies. Currently, HAS recommends the vaginal route at the dose of 800μg for stopped pregnancies. It is therefore necessary to compare the different routes of administration of Misoprostol at the same dose to allow to change our French recommendations on the medicinal abortion and perhaps also to recommend the vaginal route in this indication.


Eligibility criteria: Inclusion Criteria:

* Women \> 18 years hospitalized using abortions between 7 and 9 SA and after informed consent,
* Affiliation to a social security scheme.

Exclusion Criteria:

* Minor or major women under guardianship or curatorship
* BMI \<18.5 (thinness)
* Ambulatory
* Several abortions on the duration of the study
* Take Mifepristone\> 48 hours before taking Misoprostol
* Contraindications to Misoprostol: Prostaglandin Allergy

Primary outcomes:
measure: Complete pregnancy evacuation on ultrasound at 3 weeks
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT01573884: Ex Vivo Exploratory Analysis in Healthy Full-term Infants
Official title: Ex Vivo Exploratory Analysis in Healthy Full-term Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Infant and Mother Pairs
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2012-04-10
Enrollment: 54
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infant and mother pairs

Brief summary: * Exploratory analyses of the immune response in a ex vivo culture system
* Characterization of the composition of maternal milk and infant urine


Eligibility criteria: Inclusion Criteria

* Infant or infant-mother pair in good health
* Infant or infant-mother pair is from smoke-free home
* Infant is a singleton, full term
* birth weight was \> 2490 g
* Between 0 and 17 days of age at enrollment
* Human milk fed infants must have been exclusively human milk-fed since birth; formula fed infants must have received Similac Advance or Similac Sensitive since birth
* Parents confirm their intention not to administer vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D), solid foods or juices to their infant from enrollment throughout the study

Exclusion Criteria:

* An adverse maternal, fetal or infant medical history, including gestational diabetes that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
* Infant has been treated with antibiotics
* Participation in another study -

Primary outcomes:
measure: Viral load in cell cultures
timeFrame: 14 days
Secondary outcomes:
measure: Changes in viral load and cytokine profiles
timeFrame: 14 days
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Northpoint Pediatrics
state: Indiana
city: Mayfield Heights
country: United States
facility: Institute of Clinical Research
state: Ohio
Study officials:
affiliation: Abbott Nutrition
name: Karen Goehring, MS
role: STUDY_CHAIR
References:
Clinical trial NCT05221684: Lymph Node Ratio as a Predictor for Outcome in Rectal Cancer
Official title: Lymph Node Ratio as a Predictor for Outcome in Rectal Cancer: a Retrospective Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Recurrence
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with rectal cancer TNM stage I-III Who underwent surgery with curative intent

Brief summary: This study aims to evaluate the value of the LNR as a prognostic indicator in patients with rectal cancer who offered total mesorectal excision.

Detailed description: Patients and methods Study design and setting This is a retrospective review of prospectively collected and maintained database of patients with CRC admitted in the Oncology Center of Mansoura University (OCMU), the Colorectal Surgery Unit of Mansoura University Hospitals, and the Department of General Surgery of Alexandria University.

Selection criteria Patients of either gender aged 18 years or above who presented with rectal cancer of any stage will be included in the study. We will exclude patients with patients younger than 18 years; patients with synchronous colon cancer; synchronous liver, pulmonary or bones metastasis; or synchronous gastrointestinal cancer; or patients who were lost to follow-up.

Study endpoints The primary endpoint of the study is to assess the value of lymph node ratio (LNR) on the oncological outcomes.

Eligibility criteria: Inclusion Criteria:

* rectal cancer of TNM stage I-III
* underwent radical resection with curative intent

Exclusion Criteria:

* synchronous colon cancer
* synchronous gastrointestinal cancer
* underwent palliative resection
* presented with intestinal obstruction
* those lost to follow-up.

Primary outcomes:
measure: Lymph node value
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura Faculty of Medicine
state: Dakahliya
Study officials:
affiliation: Mansoura Faculty of Medicine
name: Mostafa Shalaby
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02695784: Probiotics After Discharge
Official title: Probiotics After Discharge (PAD) Study: Impact on Microbiome, Health and Growth Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Microbiota
Bacteriophages
Infantile Colic
Growth
Lead sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: Northumbria University
First posted: 2016-03-01
Enrollment: 40
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The influence of the preterm gut microbiota in health and disease has been well established. However, relatively little is known about how the microbiome changes after discharge and its relationship with growth, health and disease outcomes in the preterm population. This study aims to follow a cohort of preterm infants and explore the relationship of the later microbiome ('after discharge') with later growth and health outcomes in infancy. The study will also explore the effect of timing of stopping routinely administered probiotics on the post-discharge microbiome, infant feeding and outcomes such as colic.

The investigators aim to longitudinally follow 40 infants born before 32 weeks gestation who have also taken part in the investigators microbiome study during their NICU stay (SERVIS REC No: 10/H0908/39) and where microbiomic sampling has been adequately achieved. The investigators will collect stool at and beyond the time of anticipated discharge (beyond 34 weeks) targeted to include pre- and post-weaning, and again at a year. Actual discharge timing of these infants varies, and is usually latest in the most immature infants, allowing an assessment of the influence of physical location (NICU vs home) as well as increasing age. Using 16S ribosomal RNA amplicon analysis, the investigators will assess bacterial colonisation of the gut and measure infant weight, length and head circumference at each time point. The investigators will use a parent questionnaire to assess daily crying time, parents' perceptions of colic severity using a visual analogue scale as well as vomiting and constipation for the two weeks before sampling.


Eligibility criteria: Inclusion Criteria:

* \<32 weeks Corrected Gestation
* Followed up in Newcastle Region

Exclusion Criteria:

-

Primary outcomes:
measure: Microbiome
timeFrame: one year
Secondary outcomes:
measure: Growth Velocity
timeFrame: 1 year
measure: Head Growth
timeFrame: 1 year
measure: Growth: Length
timeFrame: 1 year
Other outcomes:
Locations:
city: Newcastle Upon Tyne
country: United Kingdom
facility: Newcastle Neonatal Service
state: Tyne And Wear
Study officials:
affiliation: Newcastle NHS FOundation Trust
name: Janet Berrington
role: PRINCIPAL_INVESTIGATOR
References: