louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03354078: Effect of Subcutaneous Tissue Closure on Wound Complications
Official title: The Effect of Subcutaneous Tissue Closure Technique in Cesarean Section on Reducing Postoperative Wound Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section
Keywords: Cesarean section
Wound infection
Gapping
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Only a small number of research studies evaluated the impact of various subcutaneous tissue and skin closure methods at cesarean section. In a meta-analysis a major decline in incision site rupture was revealed when suturing the subcutaneous tissue in women with a subcutaneous depth \>2 cm.

Detailed description: Postoperative wound complications are one of the great issues in cesarean section (CS) with an incidence ranging from 3% to 30%.1 Obesity, operative time, diabetes, age of the patient, anemia, associated infection (e.g chorioamnionitis), the use of internal monitoring, delayed labor with many vaginal examinations and reduced nutrition are recognized risk factors for wound infections.

Evaluating the various techniques for closure of the subcutaneous layer.

Eligibility criteria: Inclusion Criteria:

* All patients included in this research BMI ≥ 30, First cesarean section performed, no medical disorders with pregnancy e.g DM, HTN. All patients were subjected to full history taking, examination.

depth of subcutaneous tissue estimated by a special device used (sterilized operative ruler). number of sutures estimation

Exclusion Criteria:

* The following patients were excluded BMI \<30, Previous CS, DM with pregnancy, HTN with pregnancy

Primary outcomes:
measure: The number of participants who passed without postoperative complications
timeFrame: one month post cesarean section
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algazeerah hospital -Location (Giza -Egypt )
name: Mahmoud Alalfy, M.s.c
role: STUDY_CHAIR
References:
citation: Alalfy M, Elgazzar A, Fares T, Nagy O, Ellithy A, Lasheen Y, Kamel A, Soliman M, Hassan A, Samy A, Taher AM, Ogila AI, Saad H, Salah H, Ramadan M, Nabil M, Hatem DL, Fikry M. Effect of subcutaneous tissue closure technique in cesarean section on postoperative wound complications in obese Egyptian women. J Matern Fetal Neonatal Med. 2019 Aug;32(15):2452-2459. doi: 10.1080/14767058.2018.1438399. Epub 2018 Feb 20.
Clinical trial NCT01120678: Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay
Official title: Improved Detection of Neonatal Sepsis Using a Targeted Biomarker Assay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Sepsis
Keywords: cytokines
neonatal sepsis
diagnosis of sepsis
bacteremia
blood culture
clinical sepsis
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Wallace H. Coulter Foundation
First posted: 2010-05-11
Enrollment: 250
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants in the Newborn Intensive Care Unit greater than three days of age undergoing sepsis evaluation.

Brief summary: The purpose of this study is to determine whether analysis of specific serum biomarkers will improve the diagnosis of late onset neonatal sepsis and to determine the correlation between plasma levels of specific cytokines and bacteremia in NICU patients \>3 days of age.

Detailed description: All infants in the Newborn Intensive Care Unit greater than three days old that had blood cultures sent were eligible for this study. Left-over blood from the time at blood culture was collected for research purposes. Study personnel separated the serum and stored samples at -80 degrees until analysis. Samples were analyzed in batch for neonatal sepsis biomarkers using an antibody-coated microsphere assay with dual laser detection. Clinical information collected included symptoms prompting the blood culture, CBC and culture results, and antibiotic therapy.

Eligibility criteria: Inclusion Criteria:

* NICU patients \> 3 days of age

Exclusion Criteria:

* less than 3 days old or no waste blood available

Primary outcomes:
measure: Cytokine response
timeFrame: Within the first twenty-four hours after blood cultures are obtained.
Secondary outcomes:
measure: Heart rate characteristics
timeFrame: Within twenty-fours pre and post blood culture.
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Charlottesville
country: United States
facility: University of Virginia Neonatal Intensive Care Unit
state: Virginia
Study officials:
affiliation: University of Virginia School of Medicine
name: Karen Fairchild, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01602978: Comparison of Pulse Hemoglobin and Pleth Variability Index
Official title: Comparison of Pulse Hemoglobin and Pleth Variability Index to Standard Methods of Guiding Intraoperative Fluid and Transfusion Management During Major Surgical Procedures.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia
Fluid Management
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: Masimo Labs
First posted: 2012-05-21
Enrollment: 299
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: The study population will be adults more than 18 years old that are scheduled for a major surgical procedure.

Brief summary: The purpose of this study is to investigate whether a validated sensor that is able to measure how much oxygen-carrying molecules called hemoglobin using pulse hemoglobin and Pleth Variability Index (PVI)\] are in your blood during surgery can help your doctors manage how much fluid and possibly blood you need to get during your surgery. The hope of the study is that the device may provide an early indication you are having bleeding and this may mean you need to be treated with a transfusion. Our current method of checking this is by getting a blood sample for analysis. The investigators hope is that this device may be able to alert the clinician of the need for blood or fluids without a blood draw being needed.


Eligibility criteria: Inclusion Criteria:

* Subjects must be \>18 years old;
* must be having a major surgical procedure;
* The pre-operative estimation of blood loss must be at least 15% of the total blood volume

Exclusion Criteria:

* Does subject have hemoglobinopathy;
* cardiac arrhythmias producing irregular rhythms;
* severe pulmonary disease;
* procedures where loss of more that 10 to 15% of total blood volume is unlikely;
* subject refusal

Primary outcomes:
measure: The difference between hemoglobin values from the two monitors.
timeFrame: Pulse hemoglobin will be monitored during the surgery from the first arterial blood gas drawn to the last ABG drawn.
Secondary outcomes:
measure: Difference between measures compared to patient characteristics
timeFrame: Start of surgery to end of surgery
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Davinder Ramsingh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06602778: Physical Activity Level and Sleep Quality in Type 2 Diabetes
Official title: Association of Physical Activity Level and Sleep Quality with Oxidative Stress and Exercise-related Biomarker Levels in Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus (T2DM)
Sleep
Biomarkers / Blood
Physical Activity Level
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients applying to the endocrinology department at the medical faculty hospital

Brief summary: In this study, we investigated the effects of physical activity level and sleep quality level on total antioxidant level (TAS), total oxidant level (TOS), Malondialdehyde (MDA) and Superoxide Dismutase (SOD) which are markers of oxidative stress, irisin, fibronectin type III-protein 5 (FNDC5).


Eligibility criteria: Inclusion Criteria:

* Being between 30-65 years old
* Volunteering to participate in the study
* Being literate
* Being diagnosed with Type 2 Diabetes

Exclusion Criteria:

* Having a physical or mental illness that prevents communication
* malignant disease,
* infectious disease,
* chronic obstructive pulmonary disease,
* liver disease,
* patients with kidney disease and joint or muscle disease will not be included

Primary outcomes:
measure: biomarkers derived from blood sera
timeFrame: 10 Minutes
measure: ELISA method of oxidative stress markers
timeFrame: 10 minutes
measure: Analysis of exercise-related markers by ELISA method
timeFrame: 10 minutes
measure: International Physical Activity Questionnaire
timeFrame: 5 minutes
measure: Pittsburgh Sleep Quality Index
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
Study officials:
References:
Clinical trial NCT04703478: RespiraConNosotros:a Mobile Application for COVID-19 Respiratory Rehabilitation.
Official title: RespiraConNosotros: Creation and Implementation of a Mobile Application for the Rehabilitation of Patients With Respiratory Sequelae of the SARS-CoV-2 (COVID-19)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Keywords: respiration disorders
telerehabilitation
breathing exercises
complications
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2021-01-11
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: SUPPORTIVE_CARE

Brief summary: Platform with a mobile application to encourage the performance of respiratory exercises, controlled and supervised by physiotherapists. It also includes recommendations, frequently asked questions and the possibility of contacting by chat or video calls with experts to solve possible doubts.

Currently, the application is ready for use, the registration of users and professionals is enabled and have 20 exercises divided into three intensity levels.

It is available for all platforms (PC, ANDROID, iOS). presents a simple deployment, accessible to the entire population and does not require installation.

In the future, investigators will include more languages, a greater variety of exercises and even other types of therapies. Investigators will also carry out the adaptation to functional diversity with subtitles and voice commands.


Eligibility criteria: Inclusion Criteria:

* Respiratory affectation diagnosis
* Internet access to run the application

Exclusion Criteria:

* Presence of contraindications to physical exercise or the lack of comprehensive ability to access the application will be considered.

Primary outcomes:
measure: Rating of perceived exertion (Borg Scale)
timeFrame: 10 minutes.
measure: Level of satisfaction and acceptability.
timeFrame: 20 minutes.
measure: St. George's Respiratory Questionnaire, SGRQ
timeFrame: 40 minutes.
Secondary outcomes:
measure: Age
timeFrame: 2 minutes.
measure: Sex
timeFrame: 2 minutes.
measure: Diagnosis of respiratory pathology
timeFrame: 2 minutes.
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Ines Llamas-Ramos
Study officials:
References:
Clinical trial NCT01582178: Warm Water Versus Room Temperature Water Immersion Colonoscopy
Official title: Warm Water Versus Room Temperature Water Immersion Colonoscopy - a Prospective, Randomized, Double-blind, Single-center Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colonoscopy
warm water immersion
cool water immersion
Lead sponsor: Vitkovice Hospital
Sponsor class: OTHER
First posted: 2012-04-20
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Water immersion insertion has been documented to decrease procedure-related discomfort during colonoscopy. There was used warm water infusion for colonoscope insertion in most of the water immersion colonoscopy trials.

The investigators have been using room temperature water (20-24°C) for water immersion and the investigators did not notice any drawback of it. In our opinion, it is simpler and cheaper option for water immersion colonoscopy and proof of its efficacy and safety could support the use of water immersion technique in routine practice.

The primary endpoint is cecal intubation time and the investigators suppose that the use of warm water infusion does not shorten it significantly. Patient comfort during colonoscope insertion, water consumption, length of the scope while reaching the cecum, need for external compression, need for positioning of the patient and endoscopist´s difficulty with colonoscopy will be also assessed.


Eligibility criteria: Inclusion Criteria:

* outpatient diagnostic colonoscopy
* bowel prep with macrogolum
* initial 2 mg of midazolam i.v.
* signed informed consent form

Exclusion Criteria:

* planned therapeutic intervention
* colorectal surgery in history
* known inflammatory bowel disease or colorectal cancer
* refusal of sedation

Primary outcomes:
measure: Cecal Intubation Time
timeFrame: 3 months
measure: Cecal Intubation Time
timeFrame: 1-30
Secondary outcomes:
measure: Patient Comfort During Insertion Phase of the Colonoscopy
timeFrame: 3 months
Other outcomes:
Locations:
city: Ostrava
country: Czech Republic
facility: Digestive Diseases Center, Vitkovice Hospital
Study officials:
affiliation: Digestive Diseases Center, Vitkovice Hospital
name: Premysl Falt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Falt P, Smajstrla V, Fojtik P, Tvrdik J, Urban O. Cool water vs warm water immersion for minimal sedation colonoscopy: a double-blind randomized trial. Colorectal Dis. 2013;15(10):e612-7. doi: 10.1111/codi.12336.
Clinical trial NCT01779778: Diurnal and Nocturnal Effect of Travatan With SofZia Preservative on Intraocular Pressure and Ocular Perfusion Pressure
Official title: The Diurnal and Nocturnal Effect of Travatan With SofZia Preservative on Intraocular Pressure and Ocular Perfusion Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Open Angle Glaucoma
Ocular Hypertension
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2013-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with open angle glaucoma or ocular hypertension

Brief summary: The purpose of this research study is to determine the diurnal and nocturnal effects of Travoprost with SofZia (Travatan Z) on intraocular pressure and ocular perfusion pressure.

Detailed description: The investigators hypothesize that Travatan Z will significantly lower intraocular pressure and increase ocular perfusion pressure during both the diurnal and nocturnal period, during a 24-hour evaluation, compared to baseline. The investigators further hypothesize that the medication effects will persist at 72 hours after discontinuation of the drug.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of open-angle glaucoma or ocular hypertension, including pigment dispersion glaucoma and pseudoexfoliation glaucoma
* Age ≥ 18 or ≤ 90 years, of either gender, or any race/ethnicity

Exclusion Criteria:

* Females who are currently pregnant or planning to become pregnant, as determined by history during the study period
* Diagnosis of any other form of glaucoma other than open-angle
* Schaffer angle grade \< 2 in either eye by gonioscopy
* Chronic, recurrent, or severe inflammatory eye disease
* Intraocular surgery within 6 months or laser within 3 months
* History of active, recurrent, or chronic ocular infection with the Herpes Simplex Virus
* History of cystoid macular edema
* Inability to safely discontinue all ocular medications for 4 weeks
* Patients who smoke or have irregular daily sleep patterns
* Patients who have started or changed glucocorticoids therapy in the last 3 months
* Patients who are currently undergoing medical marijuana therapy
* Any use of a non-FDA approved medication for glaucoma in the last 3 months

Primary outcomes:
measure: Changes in Intraocular Pressure
timeFrame: Every 2 hours for 24 hours
Secondary outcomes:
measure: Intraocular Pressure Change Duration
timeFrame: 72 hours
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Eye Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Leonard Seibold, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seibold LK, Kahook MY. The diurnal and nocturnal effect of travoprost with sofZia on intraocular pressure and ocular perfusion pressure. Am J Ophthalmol. 2014 Jan;157(1):44-49.e1. doi: 10.1016/j.ajo.2013.09.001. Epub 2013 Oct 30.
Clinical trial NCT02821078: Evaluation of 4D Magnetic Resonance Flow Sequence at Hepatic Level
Official title: Evaluation of 4D Magnetic Resonance Flow Sequence at Hepatic Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Magnetic Resonance Imaging
Keywords: phase-contrast MRI
blood flow
velocity mapping
abdominal imaging
Quantitative MRI
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of the project is to establish the 3D velocity mapping of the hepatic vasculature and its consistency

Detailed description: The objective of the project is to establish the 3D velocity mapping of the hepatic vasculature and its consistency. Specifically, the investigators will assess the consistency of the quantitative data by measuring hepatic blood Inflow (hepatic artery + portal vein) and outflow (inferior vena cava differential flow). According to the mass conservation physical property, blood inflow must equals blood outflow. The relative gap between the measured values will characterize the consistency of the acquisition.

Eligibility criteria: Inclusion Criteria:

* Participants have fasted for 6 hours before examination
* Adult participants

Exclusion Criteria:

* Anyone with a classic contraindication to MRI
* Recanalized umbilical vein
* Severe obesity
* Gadolinium chelate allergy

Primary outcomes:
measure: Hepatic blood flow difference
timeFrame: Day 0
Secondary outcomes:
measure: Comparison between 4D and 2D flow
timeFrame: Day 0
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Thierry Yzet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yzet T, Bouzerar R, Baledent O, Renard C, Lumbala DM, Nguyen-Khac E, Regimbeau JM, Deramond H, Meyer ME. Dynamic measurements of total hepatic blood flow with Phase Contrast MRI. Eur J Radiol. 2010 Jan;73(1):119-24. doi: 10.1016/j.ejrad.2008.09.032. Epub 2008 Nov 12.
Clinical trial NCT02046278: LifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge
Official title: LifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: LifeBond Ltd.
Sponsor class: INDUSTRY
First posted: 2014-01-27
Enrollment: 70
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: A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the anal verge.


Eligibility criteria: Inclusion Criteria:

1. Subject, or authorized representative, signed a written Informed Consent Form
2. Subject is 18 years or older
3. Subject is scheduled for elective open or laparoscopic surgery involving the creation of a circular stapled anastomosis created within 10cm from the anal verge.
4. If female - not be of child bearing potential, or be using acceptable contraception methods.
5. Subject participating in studies involving approved drug or device will be enrolled only following a mutual consideration of the investigator together with the Sponsor.

Exclusion Criteria:

1. Subject has a history of hypersensitivity to porcine derived gelatin or collagen
2. Subject participating in any other study involving an investigational (unapproved) drug or device.
3. Subject with a BMI higher than 40
4. Female Subject states that she is pregnant or breast feeding
5. Subject with ASA status higher than 3
6. Avastin use within 30 days prior to surgery
7. Subject who underwent a prior pelvic anastomosis
8. Subject is scheduled for another surgery during the follow up period of this study (not including stoma closure)

Primary outcomes:
measure: Assessment of the overall Subject safety by incidence of pre specified procedure related Adverse Events.
timeFrame: Up to 15 weeks
Secondary outcomes:
measure: Performance Rate of anastomotic leak (both radiological and clinical leaks)
timeFrame: Up to 15 weeks post procedure or at stoma closure, whichever comes first
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Ziekenhuis
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Gent
country: Belgium
facility: University Hospital
city: Leuven
country: Belgium
facility: UZ Leuven
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Malmo
country: Sweden
facility: Skane University Hospital
city: Stockholm
country: Sweden
facility: Karolinska Institutet
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
References: