louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04689139: Biomarkers in Thoracic Aorta Surgery
Official title: Role of Intraoperative Biomarkers in Prognosis of Perioperative Complications in Reconstructive Thoracic Aorta Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm
Thoracoabdominal Aneurysm
Aortic Dissection
Complication
Lead sponsor: Petrovsky National Research Centre of Surgery
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Biomarkers can play a vital role in prognosing the perioperative complications in thoracic aorta surgery. The goal of a study is to determine the correlation between intraoperative level of certain biomarkers and total amount of peroperative complications.

Detailed description: This study aims to assess the association between levels of biomarkers and postoperative complications in patients after thoracic and thoracoabdominal aortic reconstruction.

Eligibility criteria: Inclusion Criteria:

* Elective thoracic and thoracoabdominal surgery

Exclusion Criteria:

* Hemolysis in blood sample

Primary outcomes:
measure: Number of Total Postoperative Complications
timeFrame: up to 10 days
Secondary outcomes:
measure: Total Number Affected by All-Cause Mortality
timeFrame: up to 10 days
measure: Number of Participants Who Require Extracorporeal Detoxication
timeFrame: up to 10 days
measure: Number of Cardiac Disorders
timeFrame: up to 10 days
measure: Number of Vascular Disorders
timeFrame: up to 10 days
measure: Number of Infections and Infestations
timeFrame: up to 10 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Petrovsky Research National Centre of Surgery ( Petrovsky NRCS)
Study officials:
affiliation: Petrovsky NRCS
name: Boris Akselrod, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00821639: Reduction of Secondhand Smoke Exposure in Healthy Infants
Official title: Reduction of Secondhand Smoke Exposure in Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Secondhand Smoke Exposure
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-01-13
Enrollment: 130
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the effects of a health center based counselling method for the prevention of infant exposure to secondhand smoke.

Detailed description: This study, a two group randomised controled trial, investigates whether an intervention for parents would persuade them to enforce smoking bans inside the home and in other locations. A total of 130 parents with children aged 12 months or younger will be recruited. Each group (n=65) will complete a baseline and follow up questionnaire. Urine samples from the infants will be collected to measure the amount of cotinine, a metabolite of nicotine. The parent-report and infant's urinary cotinine measures will be obtained at baseline and at a 3-month follow up. In the intervention group, parents will be given three counselling sessions. For mothers, one being face to face and two telephone counselling and for fathers we will conduct three telephone counselling. The control group receives no intervention. Both groups will also complete a Fagerstrom test for nicotine dependence.

Eligibility criteria: Inclusion Criteria:

* Families with healthy infants under 12 months of age
* The infant resides with at least one smoking parent
* Parents being able to speak Persian and having a telephone

Exclusion Criteria:

* Parent(s) reporting consumption of other addictive substances
* Parent(s) in smoking cessation treatment

Primary outcomes:
measure: Infant's urinary cotinine levels
timeFrame: At baseline and at a 3-month follow-up
Secondary outcomes:
measure: Home smoking bans status, Car smoking bans status, Parental cigarette consumption
timeFrame: At baseline and at a 3-month follow-up
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences
Study officials:
affiliation: Tehran University of Medical Sciences
name: Azam Baheiraei, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01349686: Effect of Fluid Oral Intake During Labour
Official title: Fluid Oral Intake vs. Fasting During Labour: A Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor
Keywords: Food
Fluids
Labor
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2011-05-06
Enrollment: 348
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fasting during labour is a usual conduct in many hospitals around the world (due to the theorical risk of bronchoaspiration). There is little evidence supporting this conclusion. Besides, there are several studies that suggest that food intake during labour can be associated with shorter labours and a lower cesarean rate. The aim of the investigators study is to show if the oral intake of fluids during labour can reduce the first stage of labour with minimum risk to the patient.


Eligibility criteria: Inclusion Criteria:

* Gestational age \> 37 weeks.
* Cervical dilation \< 5 cms.

Exclusion Criteria:

* Maternal pathologies (diabetes, heart disease, preeclampsia)
* Breech presentation or any other condition that is an indication of cesarean section.
* Premature rupture of membranes.

Primary outcomes:
measure: Duration of labour (measured in minutes from admission to delivery)
timeFrame: Two months
Secondary outcomes:
measure: Number of cesarean sections due to prolonged second stage of labour (measured in number of cases).
timeFrame: Two months
measure: Number of cases of bronchoaspiration.
timeFrame: Two months
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas Hospital
Study officials:
affiliation: Saint Thomas Hospital, Panama
name: Jorge Espinosa, Resident
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Thomas Hospital, Panama
name: Osvaldo Reyes, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03220386: Methicillin-sensitive and Methicillin-resistant Staphylococcus Aureus (MSSA/MRSA) - Point-of-care-testing (POCT) in Clinical Decision Making
Official title: Methicillin-sensitive and Methicillin-resistant Staphylococcus Aureus (MSSA/MRSA) - Point-of-care-testing (POCT) in Clinical Decision Making
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Staphylococcus Aureus
Keywords: staphylococcus aureus
nosocomial infection
decolonization
emergency department
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients screened positive for nasal MSSA or MRSA colonization during their treatment in the emergency department receive a standardized decolonization Treatment (Octinidin nasal ointment and skin washing)
Primary purpose: PREVENTION

Brief summary: The study EPICS-6 consists of three study phases. Emergency Department patients are screened for nasal and pharyngeal colonisation with Methicillin sensitive and Methicillin resistant Staphylococcus aureus (MSSA/MRSA) using a point-of-care (POC)-PCR-testing method (cobas®LIAT®-System, Roche Molecular Systems Inc.) The first aim of this study is to describe the prevalence of MSSA/MRSA-colonisation in a routine cohort of Emergency Department patients. The second aim is to determine the impact of POC-guided decolonisation as compared to conventional laboratory testing on in-hospital infection rates with MSSA/MRSA in a pre-post-comparison study.

Detailed description: The study EPICS-6 consists of three study phases. In phase one the novel POC-PCR-testing method for MSSA/MRSA-proof (cobas®LIAT®-System, Roche Molecular Systems Inc.) is technically established and integrated in Emergency Department procedures. After evaluation of processes and sample handling the second phase of this study assesses the prevalence of positive MSSA/MRSA-POC-testing in the general ED-population and in different risk groups. Based on the results of the previous study phases, the final phase comprises an interventional pre-post-comparison study. The interventional study assesses the impact of POC-result guided early decolonisation of MSSA/MRSA-colonized patients on in-hospital infection rates with MSSA/MRSA.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Emergency Department (ED) visit in one of the participating EDs

Exclusion Criteria:

* none

Primary outcomes:
measure: MSSA/MRSA prevalence in a general ED-population
timeFrame: on admission to the ED
measure: MSSA/MRSA in-hospital infection rates
timeFrame: at discharge from hospital for up to 90 days after admission
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin - Berlin
Study officials:
References:
Clinical trial NCT04584086: Changes in the MRI Signal in Patients With Benign Tumors of the Brain and Meninges Treated With Proton Therapy: Impact of TEL and the Biological Dose Received
Official title: Changes in the MRI Signal in Patients With Benign Tumors of the Brain and Meninges Treated With Proton Therapy: Impact of TEL and the Biological Dose Received
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Brain Tumors
Proton Therapy
Keywords: MRI
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The main objective is to detect with TESLA multiparametric 3 MRI, the MRI secondary changes to protontherapy irradiation and to correlate them with TEL mapping, physical dose and biological dose. A model should thus be able to be proposed at the end of the study.


Eligibility criteria: Inclusion Criteria:

* Histologically proven or highly probable grade I meningiomas, histologically proven grade II meningiomas.
* Only meningiomas of the anterior and middle floors of the base of the skull are included.
* Indication of proton therapy retained in RCP and / or proton therapy technical staff (Caen site)
* Patient aged 18 or over
* Patient affiliated to a social security scheme
* Signature of informed consent before any specific procedure related to the study

Exclusion Criteria:

* History of brain or face irradiation.
* Implant or foreign body that can alter MRI imaging.
* Contraindication to MRI (pace maker, claustrophobia ...) - Hypersensitivity to gadoteric acid, to meglumine or to any medicine containing gadolinium
* Genetic radio sensitizing syndrome
* Known neurological comorbidities (stroke, Parkinson's, etc.) that may impact MRI data.
* Simultaneous participation in a therapeutic clinical trial
* Patient unable to undergo the trial follow-up for geographic, social or psychopathological reasons
* Pregnant or breastfeeding women
* Persons deprived of their liberty (see article L 1121-6 CSP),
* Adults who are the subject of a legal protection measure or unable to express their consent (see article L 1121-8)

Primary outcomes:
measure: Evaluate by TESLA multiparametric 3 MRI the modifications of the MRI signal :Change from Baseline at 1, 3 and 6 months
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
Study officials:
References:
Clinical trial NCT02102386: Monitoring Brain Perfusion and Cerebral Oximetry in Carotid Endarterectomy Surgeries
Official title: Monitoring Brain Perfusion and Cerebral Oximetry in Carotid Endarterectomy Surgeries
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Carotid Endarterectomy
Keywords: elective
carotid endarterectomy surgery
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled to undergo elective carotid endarterectomy at Barnes Jewish Hospital.

Brief summary: The goal of this study is to demonstrate Or-Nim's CerOx monitor ability to monitor changes in cerebral blood flow and oximetry during CEA surgery.

Procedures include:

Screening:

ECG, blood draw, neurological assessment, NIHSS

study: CerOX and TCD clock during CEA procedure, data collection from the medical record/monitors, neurological assessment, NIHSS

30 day follow-up


Eligibility criteria: Patients scheduled to undergo a CEA procedure that have consented to participate in the study will be included in this observational study.

Research Subjects: Indications for monitoring include patients scheduled for CEA that comply with the inclusion and exclusion criteria.

Inclusion Criteria

To be considered eligible to participate in this study, a patient must meet the inclusion criteria listed below:

1. Consenting patients over 18 years, undergoing elective carotid endarterectomy at Barnes Jewish Hospital.

Exclusion Criteria

To be eligible for entry into the study, the patient must not meet any of the exclusion criteria listed below:

1. Emergency surgery
2. National Institute of health Stroke Scale (NIHSS) score \>=10
3. Sub-cutaneous hematoma at the ipsilateral intended area of the CerOx probe location.
4. Laceration or scalp injury at the ipsilateral intended area of the CerOx probe location which contraindicates placement of the adhesive on the skin.
5. Patient with implants located in the intended area of the CerOx probe location.
6. Prisoners
7. Non-consenting patient Or non-participating surgeon schedule of assessments and procedures
8. Pregnant or lactating women

Primary outcomes:
measure: compare cerebral perfusion and Oximetry changes to arterial blood pressure and trans-cranial doppler velocity changes
timeFrame: up to 3 hours
Secondary outcomes:
measure: to compare cerebral perfusion and oximetry changes to non-invasive cardiac output, and systemic vascular resistances changes.
timeFrame: up to 3 hours
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington Univesity School of Medicine
name: Ivan Kangrga, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Andrea Vannucci, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04715386: Feasibility in the Prophylaxis of Radiation Dermatitis Severity
Official title: Evaluation of Feasibility in the Prophylaxis of Radiation Dermatitis Severity in Cancer Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Radiation Dermatitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-01-20
Enrollment: 14
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: Adults with head and neck cancer

Brief summary: To compare radiation dermatitis severity in irradiated skin protected by an agent verses uncovered skin based on photographs and track patient reported outcomes with use of the agent.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18years
* Undergoing external beam radiotherapy for head/neck cancer at Mayo Clinic Rochester campus.

Note: patients undergoing concurrent chemotherapy are eligible.

* Able to provide informed written consent
* Willing to consent for photography of radiation field
* Receiving a dose ≥ 45 Gy and 20 fractions to both the area being treated and the area being used for comparison

Exclusion Criteria:

* Patients with active rash, pre-existing dermatitis, lupus, tattoos, scleroderma or other conditions within the treatment area that may make skin assessment for the study difficult per treating physician discretion.
* Patients with known allergic and other systemic skin diseases even if not directly affecting irradiated fields.
* Any medical condition that in the opinion of the investigator should exclude him/her from participating in the study.
* Enrolled in an investigational study where product was applied to the proposed study site within 30 days of the screening visit
* The skin area affected by radiation requires treatment with a concomitant medication or product (if applicable)

Primary outcomes:
measure: To compare radiation dermatitis severity in irradiated skin protected by an agent versus uncovered skin (internal control) based on photographs.
timeFrame: First day of treatment and last day of radiation therapy (approximately 6 weeks, but will vary per patient) +/- 4 days
Secondary outcomes:
measure: Patient reported outcomes
timeFrame: Upon study completion, on average 6 weeks, but will vary per patient
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic Radiation Oncology
name: Ivy Petersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01159886: Patient-posture and Ileal-intubation During Colonoscopy
Official title: Patient-posture and Ileal-intubation During Colonoscopy (PIC): a Randomized Controlled Open-label Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonoscopy
Keywords: Tuberculosis
IBD
endoscopy
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2010-07-12
Enrollment: 216
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: During colonoscopy, the colonoscopist employs various maneuvers, including changing the patient's posture to left-lateral decubitus or supine, to achieve complete colonoscopic examination. Posture change has also been reported to increase the success rate of ileal intubation. However, there has been no randomized trial which has shown that a particular posture of the patient increases the success rate of ileoscopy. The present study will be carried out to determine the impact of the patient's posture (left lateral vs supine position) on success rate of ileal intubation.


Eligibility criteria: Inclusion Criteria:

* All adult (\> 12y old) patients referred for colonoscopy

Exclusion Criteria:

* Acute fulminant colitis
* Acute Intestinal obstruction
* Suspected intestinal perforation
* Peritonitis
* Pregnancy
* Severe cardio-respiratory disease (ASA grade...)
* Decompensated liver disease
* Recent pelvic or colonic surgery (in last 6 months)
* Large aortic or ileac artery aneurysm
* Human Immunodeficiency Virus Infection
* Uncooperative patients

Primary outcomes:
measure: Ileal intubation achieved or not
timeFrame: After confirmation of cecal intubation for no more than 6 minutes
Secondary outcomes:
measure: Time taken to intubate the ileum after cecal intubation
timeFrame: 6 minutes after cecal intubation and randomisation
measure: Depth of ileal intubation
timeFrame: 2 minutes
measure: Influence of endoscopist experience on successful ileal intubation
timeFrame: 6 minutes
measure: Abnormal ileal findings
timeFrame: 2 minutes
Other outcomes:
Locations:
city: Kolkata
country: India
facility: School of Digestive and Liver Diseases (SDLD), IPGME & R, Kolkata
Study officials:
affiliation: Associate Professor, Division of Gastroenterology, SDLD, IPGME & R, Kolkata-700020
name: Kshaunish Das, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00374686: Study of Prophylactic Vs Preemptive Valganciclovir
Official title: Prophylactic Vs Preemptive Oral Valganciclovir for Management of Cytomegalovirus Infection in Adult Renal Transplant Recipients: A Clinical and Pharmacoeconomic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytomegalovirus Infection
Keywords: cytomegalovirus
kidney
transplantation
valganciclovir
preemptive
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2006-09-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a study of prophylactic Vs preemptive oral valganciclovir for management of cytomegalovirus infection in adult renal transplant recipients looking at clinical and pharmacoeconomic outcomes

Detailed description: This is a study of prophylactic Vs preemptive oral valganciclovir for management of cytomegalovirus infection in adult renal transplant recipients looking at clinical and pharmacoeconomic outcomes. Patients at risk for CMV (D+/R-, D+/R+, D-/R+) were randomized to prophylaxis (valganciclovir 900 mg qd for 100 days, n=49) or preemptive therapy (900 mg bid for 21 days, n=49) for CMV DNAemia (CMV DNA level \>2000 copies/ml in ≥ 1 whole blood specimens by quantitative PCR done weekly for 16 weeks then at months 5, 6, 9, and 12. Clinical and virologic outcomes were measured and pharmacoeconomic outcomes will be analyzed

Eligibility criteria: Inclusion Criteria:

* All patients who received a kidney transplant at Washington University Medical Center between March 2003 and June 2004.

Exclusion Criteria:

* Age younger than 18
* Refusal to consent for the study
* Allergy to ganciclovir and severe illness too serious to justify randomization

Primary outcomes:
measure: Primary outcomes included occurrence of CMV infection and disease and response to therapy
Secondary outcomes:
measure: Secondary outcomes were incidence of acute rejection, allograft survival, allograft dysfunction, death, and incidence of neutropenia
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Daniel C Brennan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khoury JA, Storch GA, Bohl DL, Schuessler RM, Torrence SM, Lockwood M, Gaudreault-Keener M, Koch MJ, Miller BW, Hardinger KL, Schnitzler MA, Brennan DC. Prophylactic versus preemptive oral valganciclovir for the management of cytomegalovirus infection in adult renal transplant recipients. Am J Transplant. 2006 Sep;6(9):2134-43. doi: 10.1111/j.1600-6143.2006.01413.x. Epub 2006 Jun 19.