louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03302286: Effects of Extra Corporeal Circuit Prime on Electrolytes Balance and Clinical Outcome Following Cardiac Surgery
Official title: Effects of Extra Corporeal Circuit Prime on Electrolytes Balance and Clinical Outcome Following Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Keywords: Heart-Lung Machine
Cardiopulmonary Bypass
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 110
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: About 6000 heart operations are performed in Sweden every year. A heart-lung machine is used almost exclusively in all heart operations. This machine fills the role of heart and lungs during surgery while the heart is stopped. The extra corporeal circuit (ECC) prime results in hemodilution, as assessed from the decrease in haematocrit, electrolyte concentration and total protein content. This hemodilution is an unavoidable consequence of the use of a heart-lung machine with nonblood ECC prime. The alteration of the patient´s blood volume and electrolytes is affected by the prime solution and can be maintained within normal limits. There are no clear recommendation regarding prime components and numerous prime solutions are in use worldwide.

The aim of this study is to investigate whether the use of mannitol in heart-lung machine prime has an effect on electrolytes levels and osmolality when compared with patients who receive no Mannitol.


Eligibility criteria: Inclusion Criteria:

* adult patients of both sexes who will undergo elective isolated coronary artery bypass grafting at the Department of Cardiothoracic Surgery, Skåne University Hospital, Lund

Exclusion Criteria:

* heart failure with left ventricular ejection fraction below 50%
* small size (defined as bodyweight less than 50 kg)
* anaemia with haematocrit less than 24%
* patients with previous cardiac surgery
* patients who receive other fluids or more than 1000 ml additional Ringers's Acetate during cardiopulmonary bypass
* patients with peroperative complications including massive peroperative fluid transfusions

Primary outcomes:
measure: osmolality
timeFrame: Measurements will be taken three minutes after administration of cardioplegia during cardiopulmonary bapass.
Secondary outcomes:
measure: urine outcome
timeFrame: Measurements will be taken during first 24 hours following cardiac surgery
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Thorax
state: Skane
Study officials:
affiliation: Region Skane
name: Snejana Hyllen, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01011686: Safety Study of Autologous Cultured Adipose -Derived Stem Cells for the Fecal Incontinence
Official title: A Phase I Clinical Study of ANT-SM (Autologous Cultured Adipose-derived Stem Cell) for the Treatment of Fecal Incontinence to Evaluate Safety
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Fecal Incontinence
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-11-11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Fecal incontinence affects 18.4% adults in the community and greatly impacts quality of life. There's a problem like inconvenience, pain or allergic response in many therapeutic methods such as a surgical operation or material injection. ANT-SM is autologous adipose-derived stem cell, and so, expect of no immune responses. In this study, patients are given injection of ANT-AM in anal sphincter and followed for 4 weeks to test the safety.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years
* Wexner's fecal incontinence score \> or egal 5
* patient who has fecal incontinence for more than 6 months
* Continuity of anal sphincter at endorectal ultrasound and abnormality of anal function at anorectal manometry
* negative for urine beta-HCG for woman of childbearing age
* agreement to participate, with signed informed-consent

Exclusion Criteria:

* Anorectal surgery within the last 6 months prior to the study
* patient who is allergy to bovine-derived materials and an anesthetic
* patients with a diagnosis of auto immune disease
* Diagnosis of HBV, HCV, HIV and other infectious disease
* Patients with a diagnosis of active Tuberculosis
* Patient is pregnant or breast-feeding
* Women within 6 months post partum
* Patient who is unwilling to use an "effective" method of contraception during the study
* Patients with a diagnosis of Inflammatory Bowel Disease
* Patient who has a clinically relevant history of abuse of alcohol or drugs
* Insufficient adipose tissue for manufacturing of ANT-SM
* Patient whom investigator consider is not suitable in this study
* Patients have history of surgery for malignant cancer in the past 5 years
* Patient who has to undergo ano-rectal surgery
* Patient who has a history of artificial anal sphincter surgery
* Patient who has taken cytotoxic drugs within the last 30 days
* Patient whom investigator consider is not suitable in this study reasons for severe ano-rectal disease, severe constipation, fistula, rectal prolapsed or neurological diseases (spinal cord injury, multiple sclerosis, Parkinson's disease)

Primary outcomes:
measure: Efficacy: Wexner's score evaluation
measure: Safety: Clinically measured abnormality of laboratory tests and adverse events
Secondary outcomes:
measure: Anorectal manometry and endorectal ultrasound at week 4
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT03753386: Identification of Respiratory Profiles From Nasal Pressure Signals
Official title: Identification of Respiratory Profiles From Nasal Pressure Signals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Sponsor class: OTHER
Collaborators: name: SRETT
First posted: 2018-11-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease caused by smoking and associated with significant morbidity due to recurrent exacerbations or even hospitalizations. It is one of the leading causes of death in rich countries.

Early detection of exacerbations of the disease is thus an economic and public health issue in the world. Finding tools for automatic and early detection of an exacerbation is the subject of the study. A continuous analysis of the frequency and shape of the patients' breathing will be used.

As a first step in this study, investigators want to measure the frequency and shape of breathing in healthy subjects as they execute standard activities. These activities include resting, drinking, coughing, speaking, breathing through the mouth, physical exercise and recuperation.


Eligibility criteria: Inclusion Criteria:

* Age of majority
* Health volunteers

Exclusion Criteria:

* Pregnancy
* Age of minority
* Protected adult
* Person deprived of liberty
* Respiratory pathology
* Non affiliation to the health care system

Primary outcomes:
measure: Pressure
timeFrame: 10 Hz for 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: INSERM-UPC UMR_S 1158, Service de Pneumologie et Réanimation, GH Pitié-Salpêtrière
Study officials:
affiliation: Groupe Hospitalier Pitié-Salpêtrière
name: Jesus Gonzalez-Bermejo
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pegoraro JA, Lavault S, Wattiez N, Similowski T, Gonzalez-Bermejo J, Birmele E. Machine-learning based feature selection for a non-invasive breathing change detection. BioData Min. 2021 Jul 18;14(1):33. doi: 10.1186/s13040-021-00265-8.
Clinical trial NCT03618186: Neuroimaging Study
Official title: Neuroimaging Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Cognitive Impairment
Keywords: African Americans
neurological exam
Dementia
Alzheimer's Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-08-07
Enrollment: 240
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The researchers are trying to gather information and learn more about imaging tests in racially different people who are cognitively normal or have dementia.


Eligibility criteria: Inclusion Criteria:

* Male or female African Americans 30 years of age or older
* Subjects who have completed or are scheduled to undergo the neurological evaluation procedures described below.

Exclusion Criteria:

* Subjects unable to lie down without moving for 20 minutes.
* Women who are pregnant or cannot stop breast feeding for 24 hours.
* Claustrophobic patients unable to tolerate the scans.
* Subjects with a prolonged QT interval (as demonstrated by ECG test) cannot participate in the Tau-PET scans.
* Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc, since the quantitative PET data analysis is based on anatomic criteria that are established uniquely for each subject by registration to his/her MRI.

Primary outcomes:
measure: Tau positive scans
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Neill R Graff-Radford, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06686186: Hainan Community Cognition Cohort
Official title: A Prospective Cohort of Hainan Community Elderly Population with Cognitive Impairment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cognitive Impairment
Dementia
Age Problems
Lead sponsor: Hainan Medical College
Sponsor class: OTHER
Collaborators: name: The Second Affiliated Hospital of Hainan Medical University
name: Xuanwu Hospital, Beijing
name: Fudan University
First posted: 2024-11-13
Enrollment: 2000
Sex: ALL
Minimum age (years): 60
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community residents aged 60 years or older in Hainan Province, China

Brief summary: This is a community-based prospective cohort study in Hainan Province, China. The study was initialized in 2023 and included older residents for longitudinal follow-up. The research aims to identify risk factors as well as health and social outcomes that are associated with cognitive impairment in elderly populations, and independently develop AI-assisted software and applications for cognitive enhancement and physical rehabilitation training.

Detailed description: This is a community-based prospective cohort study in Hainan Province, China. Subjects are individuals aged 60 years and above who have lived in the communities for more than six months and have signed informed consent. The research have been initialed in 2023 and aims to identify the risk factors associated with cognitive impairment, to develop software for cognitive enhancement and physical rehabilitation training. The study includes three steps: first, to conduct cognitive function screening in 16 communities in four districts (Xiuying, Meilan, Longhua, and Qiongshan) of Haikou City and establish a database for the elderly in tropical regions; second, to identify risk factors associated with cognitive impairment in the elderly population; finally, to independently develop a software for cognitive function enhancement and physical rehabilitation training.

Eligibility criteria: * Inclusion Criteria:

  * Age 60 years and above
  * Lived in the community for more than 6 months
  * Signed the informed consent form
* Exclusion Criteria:

  * Cannot complete the survey

Primary outcomes:
measure: The prevalence and incidence of cognitive impairment base on the communities
timeFrame: An average of 1 to 2 years
measure: The prevalence and incidence of dementia using a population-based survey
timeFrame: An average of 1 to 2 years
measure: The conversion rate of normal to cognitive impairment
timeFrame: An average of 1 to 2 years
measure: The conversion rate of cognitive impairment to dementia
timeFrame: An average of 1 to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Haikou
country: China
facility: Hainan Medical University
state: Hainan
Study officials:
References:
Clinical trial NCT05301686: Is There a Correlation Between Surgical Technique for Primary Anterior Cruciate Ligament Surgery and the Risk of Subsequent Formation of Fibrous Cyst (Cyclops) in the Knee Joint, Which Leads to the Need for Surgical Removal of the Cyclops?
Official title: Is There a Correlation Between Surgical Technique for Primary Anterior Cruciate Ligament Surgery and the Risk of Subsequent Formation of Fibrous Cyst (Cyclops) in the Knee Joint, Which Leads to the Need for Surgical Removal of the Cyclops? A Registry Study With Patients Operated on With Cruciate Ligament Reconstruction at Aarhus University Hospital From 2005-2019.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cyclop Arthrofibrosis Anterior Cruciate Ligament
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 2556
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary ACL reconstructed patients operated in the period 2005-2019

Brief summary: Fibrous scar tissue formation (Cyclops) after a primary anterior cruciate ligament reconstruction (ACLr) may affect patients' ability to perform work and exercise to such an extent that further arthroscopic surgery may be necessary.

The purpose of the study is to estimate the 2-year incidence of removal of cyclops lesion after ACLr for a cohort of approximal 3000 patients operated at Aarhus University Hospital in the period 2005-2019.

Specifically, change in surgical technique and graft choice will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Patient \>18 years
* Primary ACL reconstruction

Exclusion Criteria:

* Multiligament reconstruction
* Revisions
* ACL reconstruction with double bundle graft

Primary outcomes:
measure: Cyclop lesion
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT02019186: Effects of Vitamin C and E on Endothelial Function in Adolescent Diabetes
Official title: Effects of Vitamin C and E on Endothelial Function in Adolescent Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Keywords: type 1 diabetes
endothelial function
adolescents
vitamin C
vitamin E
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 9
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The endothelium is the lining of the blood vessels that helps prevent damage to the vessels. The endothelium does not function as well as it should in adolescents with type 1 diabetes. This causes future diabetes complications. Adolescents with diabetes also have abnormalities of the cells that repair the endothelium. These abnormalities may be due to damage caused by intermittent hyperglycemia. This studied is designed to study whether low dose, combined Vitamin C and E supplementation improves endothelial function and repair in adolescents with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

1. Children and adolescent with T1D between 8 and 15 years of age will be studied.
2. Started on insulin therapy immediately after diagnosis.
3. Fasting c-peptide levels must be less than 0.4 ng/ml.
4. Hgb A1c levels greater than 8.3%.
5. All subjects must be in good health other than having diabetes. Subjects with hypothyroidism will be allowed assuming they are on stable thyroxine replacement and have normal thyroid function tests.
6. Females on oral contraceptives will also be eligible to participate.

Exclusion Criteria:

1. History oral hypoglycemic agent use.
2. BMI\>95th percentile
3. Hypertension
4. Elevated creatinine levels
5. Microalbuminuria.

Primary outcomes:
measure: endothelial function
timeFrame: 6 weeks
Secondary outcomes:
measure: Endothelial progenitor cells
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Research Institute at Nationwide Children's Hospital
state: Ohio
Study officials:
References:
citation: Hoffman RP, Dye AS, Bauer JA. Ascorbic acid blocks hyperglycemic impairment of endothelial function in adolescents with type 1 diabetes. Pediatr Diabetes. 2012 Dec;13(8):607-10. doi: 10.1111/j.1399-5448.2012.00882.x. Epub 2012 Aug 28.
citation: Dye AS, Huang H, Bauer JA, Hoffman RP. Hyperglycemia increases muscle blood flow and alters endothelial function in adolescents with type 1 diabetes. Exp Diabetes Res. 2012;2012:170380. doi: 10.1155/2012/170380. Epub 2012 Jun 3.
citation: Varvarovska J, Racek J, Stozicky F, Soucek J, Trefil L, Pomahacova R. Parameters of oxidative stress in children with Type 1 diabetes mellitus and their relatives. J Diabetes Complications. 2003 Jan-Feb;17(1):7-10. doi: 10.1016/s1056-8727(01)00228-8.
Clinical trial NCT01938586: Comparison of Traditional Superficial Cutaneous Sutures Versus Steri-Strip Coaptive Film in Layered Dermatologic Closures
Official title: Comparison of Traditional Superficial Cutaneous Sutures Versus Steri-Strip Coaptive Film in Layered Dermatologic Closures on the Back - a Prospective, Randomized, Split-scar Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound Cosmesis
Keywords: Scar
Appearance
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2013-09-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatient dermatology clinic

Brief summary: The purpose of this study is to compare the cosmetic outcome between buried intradermal and superficial cutaneous suture closures versus buried intradermal sutureand superficial Steri-Strip closures in the bilayered repair of dermatologic wounds on the back following elliptical excision of benign or malignant lesions


Eligibility criteria: Inclusion Criteria:

* 18 years or greater in age
* Simple excision of benign or malignant lesion on the back
* Final scar length of at least 3cm

Exclusion Criteria:

* Known history of keloid formation or hypertrophic scars
* Known adhesive allergy
* Pregnancy or active breast feeding

Primary outcomes:
measure: Overall scar appearance as evaluated by the Patient and Observer Scar Assessment Scale
timeFrame: 6 months
Secondary outcomes:
measure: Rates of postoperative complications
timeFrame: 6 months
measure: Time for closure of each split half portion of wound
timeFrame: 1 hour (intraoperative)
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Dermatology Clinic
state: Michigan
Study officials:
References:
Clinical trial NCT02790086: Prevalence Survey in France of Unintentional Perioperative Hypothermia and Its Impact on Two Outcomes
Official title: Prevalence Survey in France of Unintentional Perioperative Hypothermia and Its Impact on Two Outcomes: Blood Loss, Myocardial Injury After Non Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypothermia, Perioperative
Keywords: hypothermia
prevalence
perioperative
anemia
myocardial injury
troponin T
noncardiac surgery
Lead sponsor: Société Française d'Anesthésie et de Réanimation
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 2000
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing surgical intervention, requiring 2 days of hospitalization

Brief summary: The primary objectives of the study are

* to perform a survey on the clinical management of unintentional hypothermia during surgery in France.
* to assess the impact of perioperative hypothermia on anemia and myocardial injury.

Detailed description: 100 investigation centers in metropolitan France will participate in the study, targeting 2000 included patients (20 surgical interventions in each center). The duration of inclusion in each center should last at most 2 weeks.

The selected surgical interventions will be those performed with a high frequency, practiced in all types of hospitals (public, private, university hospital or not), and requiring anesthesia of at leat 30 minutes (general, epidural or intrathecal anesthesia).

Eligibility criteria: Inclusion criteria:

* Non-ambulatory surgery.
* Duration of anesthesia \> 30 minutes.
* Type of surgery: urology, gynecological, gastrointestinal, vascular and orthopedics surgery.
* Type of anesthesia: general, intrathecal or epidural anesthesia.
* patient ≥ 45 years.
* No opposition of patient to participate in the study.

Exclusion criteria:

* Emergency surgery.
* Cardiac surgery, proctology surgery or thoracic surgery.
* Digestive endoscopy or surgical radiology.
* Septic surgery.
* Patient with at least one organ failure.

Primary outcomes:
measure: Core temperature
timeFrame: up to 24 hours
measure: blood loss
timeFrame: up to 24 hours
measure: myocardial injury
timeFrame: up to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Service d'Anesthésie-Réanimation Chirurgicale, Hôpital Cochin
state: Ile de France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Pascal ALFONSI, MD
role: PRINCIPAL_INVESTIGATOR
References: