louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03052153: Intraoperative Echocardiographic Evaluation of Pulmonary Vein Velocities and Outcomes in Lung Transplantation
Official title: Intraoperative Echocardiographic Evaluation of Pulmonary Vein Velocities and Outcomes in Lung Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplant Failure
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include all surgical patients 18 years of age and older who underwent single or bilateral lung transplantation surgery during the period January 1st 2014 to November 18 2016 at Ohio State University Wexner Medical Center. Database screening for patient inclusion in retrospective analysis will be performed by designated personnel from the Anesthesiology Department or co-investigators entitled to work with patients' electronic data.

Brief summary: This study will evaluate if an association exists between levels of blood flow through the pulmonary veins and the incidence of graft dysfunction post operatively.

Detailed description: Lung transplantation surgery can be fraught with a multitude of early as well as delayed complications leading to increased morbidity and mortality. During lung transplant surgery, trans-esophageal echocardiography (TEE) is routinely used to identify cardiac anatomy and measure blood flow through the pulmonary veins. This blood flow is assessed both before and after the lung has been transplanted. Blood flow through these small caliber vessels can be impacted by many variables with a resulting reduction in blood circulating to the lung, although currently there is no agreement on an acceptable level of flow. This study will look at retrospective data from lung transplant surgeries undertaken at this institution since Jan 1st 2014 until November 18th 2016 with the goal of determining if an association exists between levels of blood flow through the pulmonary veins and the incidence of graft dysfunction post operatively.

Eligibility criteria: Inclusion Criteria:

1. All adult patients ≥ 18 years of age
2. Having undergone single or bilateral lung transplantation surgery at Ohio State University Wexner Medical Center between January 1st 2014 and November 18th 2016

Exclusion Criteria:

1. Patients ≤ 18 years of age

Primary outcomes:
measure: incidence of graft dysfunction
timeFrame: at 30 days post-transplant
measure: grade of graft dysfunction
timeFrame: at 30 days post-transplant
Secondary outcomes:
measure: All-cause mortality
timeFrame: at 30 days post-transplant
measure: Hospital Length of Stay
timeFrame: From hospital admission to discharge up to one year.
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Amar Bhatt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04874753: The Effect of COVID-19 Pandemia on Follow up of Patients With Chronic Kidney Disease
Official title: The Effect of COVID-19 Pandemia on Follow up of Patients With Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Chronic Kidney Diseases
Proteinuria
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with chronic kidney disease (eGFR\<60 ml/dk) between the ages 18-80 followed up in nephrology outpatient clinic.

Brief summary: COVID-19 pandemic affected the admission of patients to the hospital especially the older patients (\> 65 years old) because of curfews and the reluctance of patients to apply to the hospitals. Chronic kidney disease is characterized with the progressive loss of kidney function over the time and regular follow-up of patients for their kidney function and treatment of complications is recommended in these patients.

Detailed description: The chronis kidney disease patients followed in Nephrology outpatient unit are going to be enrolled in the study and their kidney functions (calculated with the mdrd formula to asses the estimated glomerular filtration rate (eGFR)) will be evaluated 6 months before and after the COVID-19 pandemia. And the rate of initiation of renal replacement therapies and the change in proteinuria will be evaluated 6 months before and after the COVID-19 pandemic.

Eligibility criteria: Inclusion Criteria:

* patients with chronic kidney disease on regular follow-up for 6 months before the COVID19 pandemic.

Exclusion Criteria:

* patients without chronic kidney disease
* patients not on routine follow-up for 6 months before the COVID19 pandemic

Primary outcomes:
measure: eGFR change
timeFrame: 6 months
measure: change in proteinuria
timeFrame: 6 months
Secondary outcomes:
measure: initiation of renal replacement therapies
timeFrame: 6 months
Other outcomes:
Locations:
city: Usak
country: Turkey
facility: Usak University
Study officials:
affiliation: Uşak University
name: Zelal Adıbelli
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03105453: The Microbiome in Subfertility and Assisted Reproductive Technologies (ART)
Official title: The Microbiome in Subfertility and Assisted Reproductive Technologies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Subfertility
Keywords: Assisted reproductive technologies
Microbiome
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing in-vitro fertilization

Brief summary: To assess the impact of the female genital microbiome on ART outcome.

Detailed description: The main objective of this study is to learn more about which microbial spectra are negatively or positively impacting IVF pregnancy outcome. This information is needed before proceeding to the next step in which an adaptation of the microbiome can be attempted to improve IVF outcome. The study is expected to shed light over the possible influence of the microbiome on causes for subfertility, endometrial receptivity and obstetrical complications. A diagnostic link may be found with entities that are often unexplained today, e.g. (recurrent) miscarriage and repeated implantation failure.

Eligibility criteria: Inclusion Criteria:

1. Caucasian women
2. Women undergoing an in-vitro fertilization cycle (for the first or second time)
3. Single embryo transfer
4. Day 5 embryo transfer
5. Gonadotropin-releasing hormone antagonist
6. Anti-mullerian hormone \> 0,69 and \< 3,5 µg/L
7. Body mass index ≤ 30 kg/m2
8. Signed informed consent

Exclusion Criteria:

1. Women suffering of chronic diseases which may impair pregnancy outcome (e.g. diabetes, chronic renal disease).
2. Antibiotics within 3 weeks of sampling
3. Surgical sperm retrieval
4. In-vitro maturation
5. Preimplantation genetic diagnosis
6. Grade 3 or 4 endometriosis
7. Patients unable to comprehend the investigational nature of the proposed study

Primary outcomes:
measure: Clinical pregnancy
timeFrame: 7 weeks
Secondary outcomes:
measure: Baseline microbiome profile
timeFrame: 1 week
measure: Variation of microbiome profile during assisted reproductive technologies
timeFrame: 5 weeks
measure: Microbiome profile of the embryo culture
timeFrame: 1 week
measure: Live birth
timeFrame: 43 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
Study officials:
affiliation: Clinical head
name: Christophe Blockeel, PhD
role: STUDY_DIRECTOR
affiliation: Research collaborator
name: Julie Bussche, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02887053: Methodological Developments for Magnetic Resonance Imaging (MRI)
Official title: Développement Méthodologique de l'Imagerie Par Résonance Magnétique (IRM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Keywords: MRI
Healthy subjects
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 1807
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to optimize clinical MR protocols and to validate MR acquisition parameters.


Eligibility criteria: Inclusion Criteria:

* to be over 18 year-old,
* to be able to give an informed consent,
* to have underwent a pre-inclusion medical examination,
* to present no contraindication to MR examination,
* to be enrolled in a social security plan.

Exclusion Criteria:

* subject refusal,
* subject under a measure of legal protection,
* any contraindication to MR examination (active medical device, ferromagnetic foreign body, pregnancy, morbid obesity, claustrophobia, ... ).

Primary outcomes:
measure: Image quality based on standard imaging quality criteria
timeFrame: 6 months after the last inclusion
Secondary outcomes:
measure: T1/T2 Quantitative sub studies
timeFrame: 6 months after the last inclusion
measure: Brain Functional MRI sub studies
timeFrame: 6 months after the last inclusion
measure: Cardiac function MRI sub studies: volume
timeFrame: 6 months after the last inclusion
measure: Cardiac mass MRI sub studies: mass
timeFrame: 6 months after the last inclusion
measure: Cardiac function MRI sub studies: ejection fraction
timeFrame: 6 months after the last inclusion
measure: Diffusion weighted MRI sub studies
timeFrame: 6 months after the last inclusion
measure: Diffusion tensor MRI sub studies
timeFrame: 6 months after the last inclusion
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU de Nancy
Study officials:
affiliation: CHRU de Nancy
name: Valérie Laurent, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU de Nancy
name: Jacques Felblinger, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06446453: Echography-guided Surfactant THERapy (ESTHER) For Preterm Infants With Respiratory Failure
Official title: Echography-guided Surfactant THERapy (ESTHER) For Preterm Infants With Respiratory Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Distress Syndrome, Newborn
Pulmonary Surfactants
Intensive Care Units, Neonatal
Lead sponsor: Connecticut Children's Medical Center
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 52
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Point-of-care ultrasound (POCUS) is the use of ultrasound by the bedside provider in real time to answer a specific question and guide medical management. POCUS can be used to diagnose the severity of neonatal respiratory distress syndrome (RDS) through a lung ultrasound score. Lung ultrasound scores have also been shown to predict if an infant is treated with an initial dose of surfactant. Therefore, using lung ultrasound scores to guide surfactant therapy for RDS will likely lead to earlier surfactant therapy and may improve short-term respiratory outcomes. This study will test this theory by comparing lung ultrasound score-guided surfactant therapy for premature infants with RDS with our current surfactant administration guidelines.


Eligibility criteria: Inclusion Criteria:

* The infant's parent/legal guardian can understand and willingly sign a written informed consent document for this study
* Birth gestational age between 27w0d-36w6d
* Diagnosis of respiratory failure secondary to RDS requiring respiratory support with non-invasive positive pressure ventilation

Exclusion Criteria:

* Unable to obtain lung ultrasound between 1-2 hours of life
* Infants already intubated or received surfactant before the point of care lung ultrasound
* Infants born with congenital cardiac disease, congenital lung disease, or congenital facial/airway malformations
* Infants born with chromosomal abnormalities
* Infants with APGARs ≤ 5 at 10 minutes of life
* Infants requiring cardiopulmonary resuscitation or therapeutic hypothermia in the first 6 hours of life

Primary outcomes:
measure: Oxygen Saturation Index
timeFrame: At 24 hours of life.
Secondary outcomes:
measure: Oxygen Saturation Index
timeFrame: At 48 and 72 hours of life.
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Connecticut Children's
state: Connecticut
Study officials:
affiliation: Connecticut Children's
name: Jacob Kelner
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01299753: Catecholamine Blockade Post-burn
Official title: Clinical and Molecular Effects of Catecholamine Blockade Post-burn
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Burns
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2011-02-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Severe burn is associated with a wide array of stress, metabolic, and physiologic processes in an attempt to restore homeostasis. The catecholamine induced stress response following severe burns is particularly exaggerated and manifests detrimentally as inflammation, insulin resistance, hypermetabolism, and associated profound protein catabolism. The investigators hypothesize that catecholamine blockade will lead to restored IR signaling and result in improved post-burn morbidity. The investigators will further determine the molecular mechanisms mediating these effects.


Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 90 years of age
* \>25% TBSA burn

Exclusion Criteria:

* Death upon admission
* Decision not to treat due to burn injury severity

Primary outcomes:
measure: Perform oral glucose tolerance test
timeFrame: Conduct at week 1 post admission
measure: Perform oral glucose tolerance test
timeFrame: Conduct at week 3 post admission
measure: Perform oral glucose tolerance test
timeFrame: Conduct at discharge (1-4 months post admission depending on severity of injury)
Secondary outcomes:
measure: Measure concentrations of serum cytokines
timeFrame: weekly until discharge (1-4 months post admission depending on severity)
measure: Record the episodes of Pneumonia
timeFrame: daily until discharge (1-4 months post admission depending on severity)
measure: Record the episodes of sepsis
timeFrame: daily until discharge (1-4 months post admission depending on severity of injury)
measure: Measure the levels of activated signaling proteins using protein blotting
timeFrame: assess at 1st operation (week 1-2 post admission on average) and 3rd operation (week 3-4 post admission on average)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Ross Tilley Burn Centre - Sunnybrook HSC
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Marc G Jeschke, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06176053: Feasibility and Acceptability of Home-based Stretching Exercises in Fibromyalgia
Official title: Feasibility and Acceptability of Home-based Stretching Exercises in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Pain
Quality of Life
Lead sponsor: University College of Northern Denmark
Sponsor class: OTHER
Collaborators: name: Bispebjerg Hospital
name: University of Copenhagen
name: Aalborg University
First posted: 2023-12-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility and acceptability study
Primary purpose: TREATMENT

Brief summary: The study aims to gather knowledge about the patient's acceptance of the intervention and testing procedures, assess the adherence to the intervention, estimate the recruitment rate, and inform the sample size calculation for a subsequent randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* Patients are included if they are aged 18 to 55 years and diagnosed with fibromyalgia in accordance with the American College of Rheumatology (ACR) criteria

Exclusion Criteria:

* Non-controlled systemic disorders
* Impaired alertness or comprehension
* relevant joint disorders (e.g., severe arthritis, arthroplasty of the hip or knee, and rheumatoid arthritis)
* recent changes in therapy
* neurological and musculoskeletal conditions that could compromise assessments

Primary outcomes:
measure: Pressure pain thresholds
timeFrame: Pressure pain thresholds were measured as a baseline before the participants are instructed in the home exercises
measure: Pressure pain thresholds
timeFrame: Pressure pain thresholds were measured six-weeks after the intervention started
Secondary outcomes:
measure: Health related Quality of Life
timeFrame: Quality of life was measured as a baseline before the paticipants are instructed in the home exercises
measure: Health related Quality of Life
timeFrame: Quality of life was measured six-weeks after the intervention started
measure: Range of motion
timeFrame: Range of motion was measured as a baseline before the participants were instructed in the home exercises
measure: Range of motion
timeFrame: Range of motion was measured six-weeks after the intervention started
Other outcomes:
measure: Fibromyalgia symptoms
timeFrame: Fibromyalgia symptoms were measured as a baseline before the paticipants are instructed in the home exercises
measure: Fibromyalgia symptoms
timeFrame: Fibromyalgia symptoms was measured six-weeks after the intervention started
Locations:
city: Aalborg
country: Denmark
facility: University College of Northern Denmark
state: Select
Study officials:
affiliation: Department of Physiotherapy, University College of Northern Denmark
name: Lise Eckardt, Pt. Msc
role: STUDY_DIRECTOR
References:
Clinical trial NCT01806753: Performance of Endoscopic Submucosal Dissection According to the Sedation Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Gastric Cancer
Gastric Adenoma
Keywords: Endoscopic submucosal dissection
Sedation
Propofol
Midazolam
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-03-07
Enrollment: 157
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although proper sedation is mandatory for endoscopic procedures such as endoscopic submucosal dissection, the effects of sedation on ESD performance and complications have not been fully evaluated. In the investigators previous retrospective study, en bloc resection and complete resection rates, and procedure time could be improved by sedation with continuous propofol infusion with opioid administration by anesthesiologists. However, there are several limitations to the study including retrospective design. The investigators aimed to evaluate the relationship among sedation methods, satisfaction of endoscopists or patients, clinical outcomes, and complications after endoscopic submucosal dissection for gastric neoplasia.


Eligibility criteria: Inclusion Criteria:

1. Age, between 20 and 80
2. Early gastric cancer or adenoma, which is indicated by endoscopic submucosal dissection
3. ECOG performance status 0 or 1
4. American Society of Anesthesiologist Physical Status 1, 2, or 3

Exclusion Criteria:

1. Previous subtotal gastrectomy
2. Previous gastrostomy
3. Repeated endoscopic submucosal dissection
4. Three or more synchronous lesions
5. Allergy to midazolam, propofol, fentanyl, or remifentanil
6. Pregnancy or breast milk feeding
7. Active infection
8. Significant cardiopulmonary disease
9. Active hepatitis or severe hepatic dysfunction
10. Severe renal dysfunction
11. Severe bone marrow dysfunction
12. Severe neurologic or psychotic disorder

Primary outcomes:
measure: Satisfaction of endoscopists
timeFrame: Within 10 minutes from the end of the endoscopic submucosal dissection
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Park CH, Shin S, Lee SK, Lee H, Lee YC, Park JC, Yoo YC. Assessing the stability and safety of procedure during endoscopic submucosal dissection according to sedation methods: a randomized trial. PLoS One. 2015 Mar 24;10(3):e0120529. doi: 10.1371/journal.pone.0120529. eCollection 2015.