louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06075342: Intracardiac Hemodynamics and Myocardial Strain in Athletes and First Responders
Official title: Research of Intracardiac Hemodynamics and Myocardial Strains of Athlete's Heart
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Structure and Function
Intracardiac Hemodynamic
Lead sponsor: Chengdu Sport University
Sponsor class: OTHER
Collaborators: name: Institute of Sports Medicine, General Administration of Sport of China
First posted: 2023-10-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: athletes with training year \> 10 and WTT \> 20, athletes with training year \< 10 and WTT \< 20, healthy controls with irregular exercise habits

Brief summary: The goal of this observational study is to compare the differences of intracardiac hemodynamics and myocardial strain in athletes with different training levels to adapt to long-term high-level training in rest conditions. The main questions aim to answer are: 1. whether an increase in amplitude and duration of intracardiac hemodynamics and myocardial strain compared with healthy controls; 2. Whether significant correlations exist between the hemodynamic indices and training level.

Participants will be asked to filling out the questionnaire, such as the age, training year (the number of years the athlete has participated in any sport), technical hierarchy (promoted by the Competitive Sports Department of the General Administration of Sport of China, weekly training time in the last 6 months, height, weight, body surface area, heart rate, systolic blood pressure, and diastolic blood pressure; and will be asked to perform an examination of transthoracic echocardiography.

Researchers will compare differences of cardiac structure and function, especially the hemodynamics and myocardial strain to see if training level could affect the cardiac function through hemodynamics and myocardial strain.


Eligibility criteria: Inclusion Criteria:

* athletes and healthy control subjects without regular exercise habits;
* no specific medical history or chronic illness.

Exclusion Criteria:

* A previous history of arterial hypertension, diabetes mellitus, heart, kidney, hepatic, infectious, psychiatric, malignant, disorders, taking drugs that can influence ECG intervals, and electrolyte imbalance;
* poor echocardiographic image quality and abnormal segmental ventricular wall movement.

Primary outcomes:
measure: intracardiac hemodynamics in mmHg/mm using vector flow mapping
timeFrame: through study completion, an average of 1 year
measure: myocardial strain in % using two-dimension tissue tracking
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: wall shear stress in pascal using vector flow mapping
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu Sport University
state: Sichuan
Study officials:
References:
Clinical trial NCT03110042: HILO-HF Registry: High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure
Official title: High Versus Low SpO2 Oxygen Therapy in Patients With Acute Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Heart Failure
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients \>40 years of age presenting to the ED with AHF

Brief summary: The HILO-HF Registry is a single centre registry that will be performed to provide information on the usual baseline oxygen saturation (SpO2) in patients presenting to ED with a primary ED diagnosis of AHF


Eligibility criteria: Inclusion Criteria:

* Patients \>40 years of age presenting to the ED with AHF
* With or without tested BNP
* With or without admission to hospital for treatment of HF\\
* Patients must be recruited within the first 24 hours of presenting to the ED.

Exclusion Criteria:

* Patients on home oxygen
* Patients with known prior hypercapnic failure (PaCO2\>50 mmHg)
* Asthma
* Primary pulmonary hypertension
* Patients requiring urgent positive pressure ventilation or intubation or on \>10 L/min oxygen

Primary outcomes:
measure: Change in blood oxygen saturation levels from baseline to 72 hours
timeFrame: 72 hours
Secondary outcomes:
measure: Dyspnea on visual analogue scale (VAS) to 72 hours
timeFrame: 72 hours
measure: Change in global symptoms using Patient Global Assessment (PGA) measure to 72 hours
timeFrame: 72 hours
measure: Change in Peak Expiratory Flow
timeFrame: 72 hours
measure: Rate of patients with Worsening Heart Failure
timeFrame: 7 days
measure: 30-day composite clinical event (all-cause mortality, HF readmission, days alive and out of hospital)
timeFrame: 30days
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta Hospital / Mazankowski Alberta Heart Institute
state: Alberta
Study officials:
affiliation: University of Alberta
name: Justin Ezekowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03591042: Universal Transvaginal Cervical Length Screening Program for Prevention of Preterm Birth in Singletons Without Prior Preterm Birth
Official title: Universal Transvaginal Cervical Length Screening Program for Prevention of Preterm Birth in Singletons Without Prior Preterm Birth: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preterm Birth
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 1334
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a non-blinded randomized screening trial of asymptomatic singleton pregnancies without prior spontaneous preterm birth who are randomized to either transvaginal ultrasound cervical length screening program (i.e. intervention group) or no screening (i.e. control group). Women are consented and randomized at the time of their routine anatomy scan between 18 0/7 and 23 6/7 weeks. Women randomized in the transvaginal ultrasound cervical length screening will receive a single transvaginal ultrasound cervical length measurement after the anatomy scan. The cervical length will be measured by operators with certification of competence in the technique.


Eligibility criteria: Inclusion criteria are:

* Singleton gestations
* No prior SPTB

Exclusion criteria are:

* Multiple gestations
* History of SPTB in a prior pregnancy
* Rupture of membranes at the time of randomization
* Known major fetal structural (i.e. defined as those that are lethal or require prenatal or postnatal surgery) or chromosomal abnormality
* Fetal death at the time of randomization
* Cerclage in situ at the time of randomization
* Pessary in situ at the time of randomization
* Vaginal bleeding at the time of randomization
* Women who are unconscious, severly ill, mentally handicapped, or under the age of 18 years.

Primary outcomes:
measure: preterm birth rate
timeFrame: Less than 37 weeks
Secondary outcomes:
measure: preterm birth rate
timeFrame: ess than 24, 28, 32, 30, and 34 weeks gestation
measure: admission to neonatal intensive care unit
timeFrame: time of delivery
measure: neonatal death
timeFrame: Between birth and 28 days of age
measure: birth weight
timeFrame: time of delivery
measure: Composite of adverse perinatal outcomes
timeFrame: Between birth and 28 days of age
measure: perinatal death
timeFrame: Between birth and 28 days of age
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Gabriele Saccone
city: Napoli
country: Italy
facility: Seconda Università di Napoli Luigi Vanvitelli
Study officials:
References:
Clinical trial NCT06717542: Tissue Analysis of Liver Grafts as a Predictor of Transplant Outcome.
Official title: Tissue Analysis (Histological, Ultrastructural and Molecular) of Liver Grafts as a Predictor of Transplant Outcome.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatic Transplantation
Rejection; Transplant, Liver
Keywords: Transplant
Liver
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-12-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm designed
Primary purpose: DIAGNOSTIC

Brief summary: Despite the good clinical results in terms of outcome with the application of HOPE prior to liver transplantation, very little is still known about the phenotypic and molecular changes that occur during perfusion/preservation during HOPE, particularly with regard to endothelial trophism and activation. Delving into these aspects would be very useful to allow personalised perfusion treatments in the future, thus improving the outcome of transplantation.

Detailed description: The primary aim of the study is the identification of specific 'endothelial signatures' (markers on tissue with immunohistochemistry and gene expression with RT-PCR) in liver grafts after HOPE treatment, predictive of transplant outcome. Interventional study without drug, including two cohorts of patients: (1) liver donors, on whom an allocation biopsy for organ quality will be performed (as standard of care); (2) liver recipients (from donors in cohort 1) on whom a study-specific biopsy will be performed as soon as the transplant has taken place (after vascular anastomoses with organ revascularisation). The study-specific biopsy constitutes the intervention of the study; patients will be treated according to the judgement of the physician and the information reported in the Technical Data Sheet of each product of any concomitant therapies administered according to clinical practice.

Eligibility criteria: Inclusion Criteria:

* For Donors:

Availability of enough tissue for histological, immunohistochemical and RT-PCR analysis.

* HOPE performed on the liver graft prior to transplantation.
* For Recipients:
* Availability of enough tissue for histological, immunohistochemical and RT-PCR analysis.
* Age greater than/equal to 18 years.

Exclusion Criteria:

* None

Primary outcomes:
measure: Identification of specific '"endothelial signatures"
timeFrame: Within 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Francesco Vasuri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01106742: Agaricus Blazei Murill (ABM) in Patients With Inflammatory Bowel Disease (IBD)
Official title: Potential Anti-inflammatory Effect of Mushroom Extract From Agaricus Blazei Murill (ABM) in Patients With Inflammatory Bowel Disease (IBD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inflammatory Bowel Disease
Keywords: Inflammatory
AbM
IBD
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2010-04-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Based on the anti-inflammatory and stabilising effect of the AbM, (Agaricus Blazei Murill) based mushroom extract AndoSanTM on cytokine release in blood in vivo and ex vivo in healthy volunteers after 12 days consumption, the aim in this study is to investigate whether same effect is valid in patients with IBD (inflammatory bowel disease). In addition, calprotectin an abundant cytosolic protein in neutrophils and a surrogate marker for degree of intestinal inflammation will be measured in blood and feces of these patients.


Eligibility criteria: Inclusion Criteria:

* Moderate disease activity

Exclusion Criteria:

* No use of Imurel (Azathioprin) or anti-TNF treatment

Primary outcomes:
measure: The ultimate goal is to see whether the ABM can be used as additional treatment of IBD.
timeFrame: 12 days
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Department of Surgery
Study officials:
References:
Clinical trial NCT00368342: Chronic Bronchiolitis or Resistant Asthma?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
First posted: 2006-08-24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chronic Bronchiolitis or Resistant Asthma? Testing a way to diagnosis and treatment


Eligibility criteria: Inclusion Criteria:

* Difficult asthma

Exclusion Criteria:

* Patients with potential allergic bronchopulmonary aspergillosis i.e. with peripheral blood eosinophilia, sputum eosinophilia, or any sputum production and bronchiectasis
* A history of smoking
* Significant occupational or environmental exposures
* Evidence on emphysema on chest high resolution computed tomography (HRCT) scan

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Research Center of Chemical Injuries, Baqyatallah Medical Sciences University, Tehran, Iran
name: Mostafa Ghanei, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03957642: Systematic Imaging Examination in ODD
Official title: Diagnostic Value of Systematic Imaging Examination in Embedded Optic Disc Drusen in Adolescents With Mild Visual Impairment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Optic Disk Drusen
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents with mild visual impairment accompanied by disc flushing, crowded optic disc, and a blurred disc halo.

Brief summary: To evaluate the diagnostic value of systematic ophthalmologic imaging examination in the diagnosis of embedded optic disc drusen (ODD) in adolescents with mild visual impairment.

Detailed description: Patients are evaluated through optometric examination, fundus photography, visual field examination, OCT, US, and FFA.

Eligibility criteria: Inclusion Criteria:

1. Male or female.
2. Age 14-28.
3. The results of visual acuity examination suggest mild visual impairment.
4. The results of ophthalmologic examination showed that the blurred degree of the local boundary of the optic disc was different and the optic disc was congested.

Exclusion Criteria:

1. patients with amblyopia.
2. patients with neurological disease.

Primary outcomes:
measure: detection rate of embedded ODD
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The third affiliated hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Xiuhua Jia, Dorctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06536842: Wound Drain After Lumbar Fusion Surgery
Official title: Postoperative Outcomes Following Primary Lumbar Fusion in Patients With and Without a Drain: A Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Lumbar Fusion
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative drain placement is often used following spine surgery. These drains are placed with the intention to decrease the incidence of postoperative hematoma and its associated complications including wound complications, infections and neurologic compression.

The use of drains, however, are not without its disadvantages including the risk of retrograde infection, increased postoperative blood loss, increased length of stay and increased hospital costs. The purpose of this study is to evaluate the postoperative outcomes and complications in patients undergoing primary lumbar fusion with and without a postoperative drain


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Undergoing primary lumbar fusion or decompression and fusion for 1-2 levels
* Surgery indicated for lumbar degenerative disease

Exclusion Criteria:

* Undergoing revision surgery
* Surgery indicated for infection
* Intraoperative dural tear
* Surgery requiring intraoperative transfusion

Primary outcomes:
measure: Incidence of postoperative complications
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00520442: Acute Pediatric Fracture Analgesia Study
Official title: Ibuprofen Versus Acetaminophen With Codeine In Acute Pediatric Forearm Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fracture
Keywords: fracture
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Children's Hospital and Health System Foundation, Wisconsin
First posted: 2007-08-24
Enrollment: 335
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical trial comparing ibuprofen and acetaminophen with codeine for children after discharge from the emergency department. We hypothesize that Ibuprofen will provide 20% more effective analgesia compared to acetaminophen with codeine in children with uncomplicated forearm fractures.

Detailed description: A clinical trial comparing ibuprofen and acetaminophen with codeine for children after discharge from the emergency department. We hypothesize that Ibuprofen will provide 20% more effective analgesia compared to acetaminophen with codeine in children with uncomplicated forearm fractures. A random table will be used to generate an assignment of the participants to either ibuprofen or acetaminophen with codeine. Assessment of the child's pain severity, pain medication use, functional limitations and parental satisfaction will allow for identification of a difference in the management of pain in the first 72 hours after a forearm fracture. Descriptive statistics will be used to analyze demographic data.

Eligibility criteria: Inclusion Criteria:

* Children ages 4-18 years of age with an uncomplicated forearm fracture that is evaluated within 12 hours of injury and requires only splinting

Exclusion Criteria:

* A history of a bleeding disorder, uncontrolled chronic medical disease, regularly use of or allergy to acetaminophen, ibuprofen, or codeine or developmental delay

Primary outcomes:
measure: Change to rescue medication
timeFrame: First 72 hours after ED discharge
Secondary outcomes:
measure: Pain score
timeFrame: First 72 hours after ED discharge
measure: Functional outcomes: eat, sleep, play, school
timeFrame: First 72 hours after ED discharge
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Amy L Drendel, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04359342: Protein Supplementation and HIIT: Impact on Cardiorespiratory Fitness
Official title: Effects of High-intensity Interval Training Combined With Post-exercise Protein Supplementation on Cardiorespiratory Fitness in Untrained Individuals: a Double-blind Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Prevention
Health Promotion
Keywords: Aerobic exercise
Cardiorespiratory Fitness
High-intensity interval training (HIIT)
Resistance training
Protein intake
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Parallel Assignment parallel-group, randomized, double-blind, placebo-controlled study
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the effects of an 8-week high-intensity interval training (HIIT) or HIIT plus resistance training program combined with post-exercise protein supplementation on cardiorespiratory fitness and cardiometabolic risk indices in previously untrained individuals.


Eligibility criteria: Inclusion Criteria:

• Sedentary Lifestyle over at least 6 months prior to the study

Exclusion Criteria:

* Pregnancy, Lactation
* Psychological disorders, epilepsy, sever neurological disorders
* Participation in other exercise- or nutrition studies within the last 6 months
* coronary heart disease, heart failure
* malignant disease
* severe rheumatic or neurological disease
* severe/unstable hypertension (resting RR: \>180/\>110 mmHg)
* severely restricted lung function (FEV1 \<60%)
* unstable Diabetes mellitus
* severe orthopedic disease/restriction
* acute / chronic infectious diseases
* Electronic implants (defibrillator, pacemaker)
* Persons in mental hospitals by order of authorities or jurisdiction

Primary outcomes:
measure: Cardiorespiratory Fitness (CRF)
timeFrame: 8 weeks
measure: Muscle strength (only in groups with resistance training)
timeFrame: 8 weeks
Secondary outcomes:
measure: Cardiometabolic Risk Score (MetS-Z-Score)
timeFrame: 8 weeks
measure: Muscle mass
timeFrame: 8 weeks
measure: Fat mass
timeFrame: 8 weeks
measure: Insulin sensitivity
timeFrame: 8 weeks
measure: Inflammation status
timeFrame: 8 weeks
measure: Health-related quality of life
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Study officials:
affiliation: University Erlangen Nuremberg Medical School
name: Dejan Reljic, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Erlangen Nuremberg Medical School
name: Yurdagül Zopf, Prof.
role: PRINCIPAL_INVESTIGATOR
References: