louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01681758: An Assessment of Pulse Pressure Variation to Guide Fluid Therapy in Cardiac Surgery Patients
Official title: A Before-and-after Assessment of Pulse Pressure Variation Guided Fluid Therapy in Cardiac Surgery Patients Receiving Mandatory Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cardiac Surgery
Keywords: cardiac surgery
Pulse pressure variation
intravenous fluids
Lead sponsor: Austin Health
Sponsor class: OTHER_GOV
First posted: 2012-09-10
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We aim to test the hypothesis that fluid therapy based on pulse pressure variation (PPV) in patients after cardiac surgery who are mechanically ventilated leads to a significant decrease in the amount of fluid given to such patients in the first 24 hours after surgery

Detailed description: 1. The investigators will study patients after cardiac surgery
2. The investigators will collect data on standard care in pre-intervention population
3. The investigators will collect demographic and clinical data
4. The investigators will collect biochemical data in the first 24 hours after surgery
5. The investigators will collect biochemical, physiological and clinical outcome data
6. The investigators will compare the standard care and intervention period data

Eligibility criteria: Inclusion Criteria:

1. immediately after ICU admission after cardiac surgery
2. mandatory mechanical ventilation -

Exclusion Criteria:

1. Pressure support ventilation
2. ECMO
3. Intra-aortic balloon counterpulsation

Primary outcomes:
measure: Mean amount of fluid given in the first 24 hours after surgery
timeFrame: 24 hours
Secondary outcomes:
measure: Physiological outcome
timeFrame: 24 hours
Other outcomes:
measure: Physiological outcome
timeFrame: 24 hours
Locations:
city: Melbourne
country: Australia
facility: Austin Hospital
state: Victoria
Study officials:
References:
citation: Suzuki S, Woinarski NC, Lipcsey M, Candal CL, Schneider AG, Glassford NJ, Eastwood GM, Bellomo R. Pulse pressure variation-guided fluid therapy after cardiac surgery: a pilot before-and-after trial. J Crit Care. 2014 Dec;29(6):992-6. doi: 10.1016/j.jcrc.2014.07.032. Epub 2014 Aug 7.
Clinical trial NCT02097758: Efficacy of Three Dimensional Transesophageal Echocardiography for Percutaneous Device Closure in Atrial Septal Defect
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Septal Defect
Successful Device Closure
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2014-03-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Background: Three-dimensional echocardiographic image for atrial septal defect (ASD) is useful for evaluation of defect size and shape. The investigators suggested optimal device size using three-dimensional transesophageal echocardiographic image and our formula in previous study.

Purpose: In this study, the investigators seek to predict the correct device size and confirm the accuracy of the formula that we made before device closure in ASD patients.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 year-old
* Susceptible indication for atrial septal defect closure
* Potential candidate for device closure

Exclusion Criteria:

* Poor candidate for device closure: multiple ASDs, ect
* Other heart disease requiring open heart surgery

Primary outcomes:
measure: Successful device implantation
timeFrame: 1 day
Secondary outcomes:
measure: Procedure time
timeFrame: during procedure
Other outcomes:
measure: Complications from device
timeFrame: 1 year
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Jong-Min Song, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jang JY, Heo R, Cho MS, Bae J, Hong JA, Lee S, Ahn JM, Park DW, Kim DH, Kang DH, Song JK, Song JM. Efficacy of 3D transoesophageal echocardiography for transcatheter device closure of atrial septal defect without balloon sizing. Eur Heart J Cardiovasc Imaging. 2018 Jun 1;19(6):684-689. doi: 10.1093/ehjci/jex153.
Clinical trial NCT03586258: Neuropsychological and Brain Medical Imaging Study in Patients With Brain Damage 2
Official title: Anatomical Clinical Correlations. Neuropsychological and Brain Medical Imaging Study in Brain Damage Subjects 2 (CORAC2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebrovascular Disorders
Brain Lesion
Degenerative Disease
Developmental Disability
Keywords: Neuropsychological study
Brain imaging
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2018-07-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Two groups of subjects will be constitute: (i) patients with circumscribed brain injury (including stroke, vascular malformations, tumor or circumscribed infectious lesions) or degenerative/developmental disorders and selective cognitive disorders; (ii) healthy control subjects.

The objective of this project is to evaluate specific neuropsychological deficits and apply current brain imaging techniques (anatomical, diffusion, functional, magnetic stimulation) to patients suffering from these cognitive deficits due to brain damage, in order to elucidate the brain mechanisms underlying these deficits.


Eligibility criteria: Inclusion Criteria:

* Age \> 17 years
* French language
* Effective contraception for women during the study
* Informed consent
* No alcohol intake the day before the exam
* For patients only, focal cerebral lesion (stroke, malformation, tumor, inflammatory, infectious, traumatic), neonatal pathology, developmental or degenerative disease with cognitive deficit

Exclusion Criteria:

* For healthy volunteers: previous neurological history (except non complicated migraine or epilepsy), previous psychiatric history (except depression with good evolution or anxiety), or severe cranial traumatism
* For patients: vigilance disorders, severe depression or anxiety.
* For both: psychotropic medication other than a hypnotic or an anxiolytic at low doses without dose modification for at least one month, severe visual or auditory impairment, patient without judicial or administrative liberty, measure of legal protection or no capable to express their consent, pregnancy or breastfeeding, contraindication for MRI or GVS if applicable, participation in another trial or former involvement in another trial within one month.

Primary outcomes:
measure: Cognitive Deficit
timeFrame: 3 months to more than 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
affiliation: Caen University Hospital, Normandie UNIV, UNICAEN, PSL Research University, EPHE, Inserm, U1077, CHU de Caen, Neuropsychologie et Imagerie de la Mémoire Humaine, 14000 Caen, France
name: Olivier MARTINAUD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06076096: SIFIB As an Anesthesia Method for Lower Extremity Surgeries
Official title: Ultrasound-Guided Supra-Inguinal Fascia Iliaca Block As an Anesthesia Method for Lower Extremity Surgeries: A Single-Center Retrospective Cohort Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Anesthesia Management
Regional Anesthesia
Keywords: Regional Anesthesia
Anesthesia Management
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Specifically, we included patients who underwent SIFIB either as the primary anesthesia method or as a component of the anesthesia plan.

Brief summary: The Ultrasound-guided Supra-inguinal Fascia Iliaca Block (SIFIB) is an advanced regional anesthesia technique strategically directed at the three primary nerves of the lumbar plexus. As the scope of regional anesthesia methods continues to grow in clinical application, this approach emerges as a versatile method. It can be used independently for pain management or as the primary anesthetic method, particularly in well-selected patients undergoing isolated limb surgeries or in combination with other regional anesthesia approaches.

Detailed description: The study follows a retrospective cohort feasibility design, conducted within the confines of a tertiary hospital. The requisite data for analysis was acquired by accessing patient records and electronic data systems. A cohort of 16 patients was carefully chosen for inclusion in the study, and the administration of blocks was carried out before the surgical procedures.

Eligibility criteria: Inclusion Criteria:

* ASA I-III patients who underwent elective lower limb surgical procedures.

Exclusion Criteria:

* Patients who received general anesthesia, neuraxial anesthesia, or infiltration anesthesia were excluded.

Primary outcomes:
measure: Block Success which provided surgical anesthesia, intraoperatively
timeFrame: Intraoperatively and PACU unit (up to 2 hours)
Secondary outcomes:
measure: Additional analgesic requirement
timeFrame: Intraoperatively and PACU unit (up to 2 hours)
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun University
Study officials:
affiliation: Samsun University
name: Serkan Tulgar, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02208596: The Feasibility of Different Doses of Etomidate Admixed With Propofol in Induced Abortion: A Randomized, Double Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Induced Abortion
Anesthesia
Lead sponsor: Third Affiliated Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the feasibility of different doses of etomidate admixed with propofol in induced abortion: a randomized, double blind controlled trial.


Eligibility criteria: Inclusion Criteria:

* Aged between 20 and 35 years
* American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ
* Singleton pregnancy and the gestational period is 6 to 8 weeks
* Expected operation duration is within 60 minutes
* The body weight should be within 15% around the standard weight
* Signed informed consent form

Exclusion Criteria:

* Serious cardiac, cerebral, liver, kidney, lung, endocrine disease
* Upper respiratory infections within 4 weeks
* Long use of hormone or history of adrenal suppression
* History of use of glucocorticoids, aprotinin or immunosuppressant
* Manifestation of immunodeficiency
* History of use of sedatives or opiates
* Needs of Neuromuscular blocker (except intubation)
* Allergy to trial drug or other contraindication
* Pregnant or breast-feeding women
* Attended other trial past 30 days

Primary outcomes:
measure: Heart rate
timeFrame: From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection
measure: Blood pressure
timeFrame: From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection
measure: Pulse oxygen saturation
timeFrame: From baseline (before the injection of propofol or mixture of propofol and etomidate) to 10 min after the injection
Secondary outcomes:
measure: Efficacy of anesthesia
timeFrame: from baseline to discharge from the hospital, expected to no more than 1 hour
measure: Dose of propofol or mixture of propofol and etomidate
timeFrame: from the injection of propofol or mixture of propofol and etomidate to the last supplement of hypnotic agents, expected to be no more than 5 min
measure: Use of specific medications
timeFrame: from the injection of propofol or mixture of propofol and etomidte to discharge from the hospital, expected to no more than 1 hour
measure: Aldrete score
timeFrame: 10 min after the opration
measure: Verbal rating scales of uterine contraction
timeFrame: from 5 min after the operation to discharge from the hospital, expected to be no more than 1 hour
measure: Satisfaction degree of the patient, the surgeon and the anesthetist
timeFrame: 10 min before discharge from the hospital
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06715696: The Hemostatic Effectiveness of "HANBIO" Gauze During Non-emergent Gynecology Surgery.
Official title: Clinical Hemostatic Effectiveness of PET-Collagen Gauze ("HANBIO" Gauze) for Acute Wound: a Prospective, Single-arm, Open-label Evaluation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds and Injuries
Hemostasis
Lead sponsor: HAN Biomedical Inc
Sponsor class: INDUSTRY
First posted: 2024-12-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to collect the hemostatic effectiveness and device safety data of "HANBIO" Gauze in subjects have acute wound result from gynecology surgery.


Eligibility criteria: Inclusion Criteria:

* Female between 20 and 70 years of age.
* Subject scheduled for a non-emergent, gynecological surgery.
* Subject has an identified bleeding site/area intraoperatively.
* Subject is willing to comply with all aspects of the study and have signed informed consent form.

Exclusion Criteria:

* Pregnant or lactating female.
* The wound is chronic wound that not healed within 8 weeks, e.g. ulcers.
* The wound is caused by radiation or burns.
* Subject is sensitive or allergic to collagen.
* Subject is sensitive or allergic to polyester (PET).
* Subject has medical history of coagulation disorder or disease (e.g., hemophilia, thrombocytopenia).
* Subject receives anticoagulants or antiplatelets.
* Subject plans to receive other hemostatic gauze/dressing/agent/medical device as primary hemostasis.
* Subject has participated in another clinical trial within the past 30 days.
* Subjects with any pre-operative or intra-operative findings that may preclude conduct of the study procedure or unable to evaluate the outcomes.

Primary outcomes:
measure: Average Time(sec) to achieve hemostasis
timeFrame: 3 min
Secondary outcomes:
measure: Proportions of subjects achieving hemostatic success at 3 min.
timeFrame: 3 min
measure: Number/proportion of adverse and serious adverse events.
timeFrame: 3 min
measure: Ease of use questionnaire of Product "HANBIO" Gauze (by Principal Investigator)
timeFrame: 3 min
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT01698996: A Randomized Blinded Trial of Abscess Management With Packing vs No Packing
Official title: A Randomized Blinded Trial of Abscess Management With Packing vs No Packing
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Uncomplicated Cutaneous Abscess
Keywords: abscess
packing
emergency medicine
wound care
incision and drainage
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Adult patients presenting to the emergency department with superficial cutaneous abscesses will be randomized after incision and drainage to standard care with wound packing or no packing to determine if there is a difference in the proportion of complications between the two groups.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years
* Abscess ≤ 5cm in diameter
* Truncal or extremity location

Exclusion Criteria:

* Post-operative abscess (abscess in location of operative incision, operation within the last 4 months)
* HIV/immunocompromised/transplant recipient/chronic oral steroid use
* Fever at triage (temp ≥38 degrees Celsius)
* Abscess secondary to Crohn's
* Multiple abscesses requiring drainage
* Prior participation in the study for the same abscess
* Incision and drainage performed with no packing required, or where abscess cavity is \<1 cm max diameter
* Bartholins/perigenital, perianal, or facial abscesses
* Complicated abscesses (fistula, suspicion of muscular extension, consultation/direct referral to general surgery)
* Inability to give consent

Primary outcomes:
measure: Proportion of complications (defined as a composite of the following: need for repeat incision and drainage by physician, need for admission to hospital, or need for escalation to intravenous antibiotics)
timeFrame: 7 days
Secondary outcomes:
measure: Proportion of wounds "closed" at 1 week (wound size <0.5 cm length and depth and no drainage)
timeFrame: 7 days
Other outcomes:
measure: Proportion of wounds "closed" at 2 weeks (wound size <0.5 cm length and depth and no drainage)
timeFrame: 14 days
measure: Pain scores (daily pain scores for first week from patient diary)
timeFrame: 7 days
measure: Amount of Pain Medication Used
timeFrame: 7 days
measure: Resources Utilized
timeFrame: 14 days
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Amit P Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01730196: Lifestyle Change to Prevent Diabetes Via African-American Churches
Official title: Fit Body and Soul: A Lifestyle Intervention for Diabetes Prevention Conducted Through African American Churches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Weight Loss
Lead sponsor: Augusta University
Sponsor class: OTHER
First posted: 2012-11-21
Enrollment: 604
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Fit Body and Soul is single-blinded, cluster- randomized trial of a faith-based adaptation of the GLB program compared with a health education intervention.


Eligibility criteria: Inclusion Criteria:

* Self-described African American
* BMI ≥25kg/m2
* Planning to remain within the community for 1 year
* Non-diabetic

Exclusion Criteria:

* Fasting plasma glucose ≥ 126 mg/dl following at least an 8-hr fast or A1C≥7.0%
* HIV/AIDS
* Active tuberculosis
* Cancer requiring treatment in past 5 years except for cancers that have been cured or in the opinion of the researchers has a good prognosis
* Stroke within the past 6 months
* Cirrhosis of the liver
* Currently pregnant or planning pregnancy within the study period
* Gastric weight-loss surgery
* Weight loss \> 10% in past three months for any reason other than childbirth
* Anti-diabetic medications
* Prescription weight- loss medications
* Anti-neoplastic agents
* Anti-psychotic agents that have gluco-corticoid effect
* Oral corticosteroid use \>6 weeks
* Unwilling or unable to give informed consent
* Unable to communicate with the church team or research group
* Participation in another research study that would interfere with FBAS

Primary outcomes:
measure: Weight change
timeFrame: 12-weeks post intervention
Secondary outcomes:
measure: Fasting plasma glucose
timeFrame: 12 week post intervention
measure: physical activity level
timeFrame: 12 week post-intervention
measure: quality of life measures
timeFrame: 12 week post-intervention
measure: cost-effectiveness
timeFrame: 12 week post-intervetnion
measure: hemoglobin A1C
timeFrame: 12 week intervention
Other outcomes:
measure: waist circumference
timeFrame: 12 weeks post-intervention
Locations:
city: Augusta
country: United States
facility: Georgia Health Sciences University
state: Georgia
Study officials:
affiliation: Augusta University
name: Richard W Sattin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rhodes EC, Chandrasekar EK, Patel SA, Narayan KMV, Joshua TV, Williams LB, Marion L, Ali MK. Cost-effectiveness of a faith-based lifestyle intervention for diabetes prevention among African Americans: A within-trial analysis. Diabetes Res Clin Pract. 2018 Dec;146:85-92. doi: 10.1016/j.diabres.2018.09.016. Epub 2018 Sep 28.
citation: Sattin RW, Williams LB, Dias J, Garvin JT, Marion L, Joshua TV, Kriska A, Kramer MK, Narayan KM. Community Trial of a Faith-Based Lifestyle Intervention to Prevent Diabetes Among African-Americans. J Community Health. 2016 Feb;41(1):87-96. doi: 10.1007/s10900-015-0071-8.
Clinical trial NCT02334358: Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Classic s
Official title: A Multi-center, Prospective and Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Classic s Injected Into the Nasolabial Folds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Correction of Nasolabial Folds
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2015-01-08
Enrollment: 503
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject who receive hyaluronic acid filler into the nasolabial folds

Brief summary: To evaluate long-term safety of YVOIRE classic s by incidence of adverse events including injection site local reactions and biodegradability


Eligibility criteria: Inclusion Criteria:

1. Subjects whose age is over 18 years old
2. Subjects whose WSRS grade is equal or greater than 2
3. Subjects must be willing and able to provide written informed consent
4. Subjects who are scheduled to be treated with YVOIRE classic s for facial tissue augmentation to correct the nasolabial folds

Exclusion Criteria:

1. Subjects who are sensitive to hyaluronic acid or any excipients of YVOIRE classic s
2. Subjects who have received permanent implantation (silicone, PAAG, PMMA, CaHA etc) on the nasolabial folds
3. Subjects who have received nonpermanent aesthetic treatments, such as botulinum toxin injection or filler on the nasolabial folds within 9 months before screening
4. Subjects who have received face lifting or plastic surgery on face within 9 months before screening
5. Subjects who have received laser therapy on the nasolabial folds, chemical peeling or peeling on face within 3 months before the screening
6. Subjects who have any skin diseases (including inflammation and skin cancer) or infectious diseases on the injection sites
7. Subjects who tend to have hypertrophic scars
8. Subjects with a history of streptococcal disease, severe allergy or anaphylaxis or bleeding disorders.
9. Women in pregnancy or lactation

Primary outcomes:
measure: Incidence of Device-related Adverse Events
timeFrame: Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
Study officials:
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Q Li
role: PRINCIPAL_INVESTIGATOR
References: