louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01212315: Effects of Triclosan-coated Sutures in Cardiac Surgery
Official title: Triclosan-coated Sutures in Cardiac Surgery:Effects on Leg Wound Infections and Costs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Wound Infection
Keywords: Wound infection
SSI
Suture
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2010-09-30
Enrollment: 392
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: TREATMENT

Brief summary: The purpose of this study is to assess if triclosan-coated sutures reduces wound infections after saphenous vein harvesting in CABG patients. Secondary objectives are the effect triclosan-coated sutures on sternal wound infections and a cost analysis.

Detailed description: The role of the suture material for the development of postoperative wound infection has been debated for many years. It has been reported that fewer bacteria adhere to monofilament polypropylene than braided polyester sutures in vitro but the results are opposed by a non-randomized clinical study where the use of monofilament sutures was identified as an independent risk factor for leg wound infections after CABG.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective CABG at Sahlgrenska University Hospital with intended use of saphenous vein graft are included.

Exclusion Criteria:

* Patients with on-going sepsis or septicaemia, bacterial infections or known allergy to triclosan are excluded.

Primary outcomes:
measure: Proportion of subjects with leg wound infection.
timeFrame: Within 60 days after heartsurgery
Secondary outcomes:
measure: Culture-proven and antibiotic-treated wound infection after heart surgery
timeFrame: Within 60 days after heart surgery
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Dep of Cardiovascular Surgery and Anesthesia, Sahlgrenska Univerity Hospital
Study officials:
affiliation: Sahlgrenska Univerity Hospital
name: Anders Jeppsson, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steingrimsson S, Thimour-Bergstrom L, Roman-Emanuel C, Schersten H, Friberg O, Gudbjartsson T, Jeppsson A. Triclosan-coated sutures and sternal wound infections: a prospective randomized clinical trial. Eur J Clin Microbiol Infect Dis. 2015 Dec;34(12):2331-8. doi: 10.1007/s10096-015-2485-8. Epub 2015 Oct 2.
citation: Thimour-Bergstrom L, Roman-Emanuel C, Schersten H, Friberg O, Gudbjartsson T, Jeppsson A. Triclosan-coated sutures reduce surgical site infection after open vein harvesting in coronary artery bypass grafting patients: a randomized controlled trial. Eur J Cardiothorac Surg. 2013 Nov;44(5):931-8. doi: 10.1093/ejcts/ezt063. Epub 2013 Feb 22.
Clinical trial NCT01365715: Preoperative Embolization in Surgical Treatment of Spinal Metastases.
Official title: Preoperative Embolization in Surgical Treatment of Spinal Metastases. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Metastases
Keywords: Preoperative embolization
Transcatheter arterial embolization
Therapeutic angiography
Embolization
Surgical blood loss
Spinal metastases
Spinal neoplasms
Vertebral metastases
metastatic spine surgery
Spinal surgery
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-06-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to assess the efficacy of preoperative embolization in decreasing operative blood loss, decreasing the need for intraoperative transfusion and facilitate surgical resection in metastatic spine surgery. Furthermore the study aims at describing the vascularity in a series of spinal metastasis, and to correlate this with perioperative blood loss.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for decompression and posterior thoracic and/or lumbar instrumented spinal fusion because of spinal metastasis/metastases.
* Informed signed consent.

Exclusion Criteria:

* Contrast fluid allergy.
* Clotting disorders.
* Renal failure.
* Not suitable for arterial access.
* Pregnancy.

Primary outcomes:
measure: Perioperative blood loss
timeFrame: Measured intraoperatively and 24 hours postoperatively.
Secondary outcomes:
measure: Perioperative blood transfusion volume
timeFrame: Intraoperatively and until 48 hours postoperatively.
measure: Surgical procedure time.
timeFrame: At skin closure.
measure: Vascularization grade of metastasis
timeFrame: At the angiographic procedure prior to embolization performed 0-48 hours before surgery.
measure: Success of embolization
timeFrame: Directly after the embolization performed 0-48 hours before surgery.
measure: Adverse events related to angiography or embolization
timeFrame: Within 2 postoperative days
measure: Adverse events related to surgery
timeFrame: Within 2 postoperative days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Radiology, Rigshospitalet
Study officials:
affiliation: Department of Radiology, Rigshospitalet. Copenhagen, Denmark.
name: Lars Lönn, MD, Ph.d.
role: STUDY_CHAIR
References:
Clinical trial NCT06663215: The Effect of School-Based Bullying Prevention Program on Bullying Victimization, Tendencies and Future Expectations of Adolescents
Official title: The Effect of School-Based Bullying Prevention Program on Bullying Victimization, Tendencies and Future Expectations of Adolescents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bullying
Keywords: peer, bullying, future expectation, bullying education
Lead sponsor: Harran University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 200
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of this study is to determine the effect of a school-based bullying prevention program on adolescents' bullying victimization, tendencies and future expectations.

Detailed description: Communication is one of the indispensable elements of human history. With the advancement in technology, the use of the internet, social media, and digital tools such as computers and cell phones has taken an important place in human life. Children and young people use the internet for different activities such as doing educational work, exchanging messages via e-mail, playing online games, shopping, using social networks, watching movies and listening to music. It is reported that the age group with the highest rates of computer and internet use is adolescents and young adults (16-24 and 25-34 age groups). Excessive and problematic use of information technologies and the transfer of relationships to virtual environments can bring about some negative situations that may occur in adolescents such as internet addiction and cyberbullying. Cyberbullying, which is the deliberate and regular use of digital technology such as computers, mobile phones and the internet to harass others, includes concepts such as cyberbullying, cyberbullying and cyber victimization. Bullying, which is a proactive behavioral problem, is a situation in which an individual or group repeatedly exhibits humiliating and aggressive behaviors to an individual or group that is relatively weaker than themselves. Bullying and cyberbullying faced by adolescents have become an important problem worldwide.The aim of this study is to determine the effect of a school-based bullying prevention program on adolescents' bullying victimization, tendencies and future expectations.

Eligibility criteria: Inclusion Criteria:

* Studying at Şanlıurfa Eyyübiye Atatürk Anatolian High School and agree to participate in the research

Exclusion Criteria:

* not meeting inclusion criteria

Primary outcomes:
measure: bullying tendency
timeFrame: 1 month
measure: bullying victimization
timeFrame: 1 month
Secondary outcomes:
measure: Future prospects
timeFrame: 1 month
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Fatma Bozdağ
Study officials:
References:
Clinical trial NCT05523115: An Exploratory Investigation of a Supplement to Promote Cognitive Health Benefits
Official title: An Exploratory Investigation of a Supplement to Promote Cognitive Health Benefits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Stress
Memory Deficits
Cortisol Overproduction
Keywords: memory
stress
anxiety
mood
focus
Lead sponsor: Heights
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2022-08-31
Enrollment: 34
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The Smart Supplement has 20 vitamins and minerals that have strong track records of demonstrating positive health effects, both physiologically and cognitively. This twelve-week trial will examine the effectiveness and efficacy of Heights Smart Supplement on both biomarkers and subjective experiences from participants.


Eligibility criteria: Inclusion Criteria:

* In good general health with no major chronic conditions
* Must experience one of the following issues: brain fog
* OR issues with fatigue,
* OR sleep issues,
* OR trouble with focus and concentration,
* OR lead a busy, stressful life.
* Must have a fitness tracker that they use to track sleep behaviors.
* May be on a vegan/vegetarian diet

Exclusion Criteria:

* Females who are pregnant or breastfeeding
* Anyone currently taking other supplements focused on brain health, or multi vitamins, including additional iron supplements
* Anyone taking Thyroxine and Levothyroxine
* Anyone taking antidepressants (such as Sertraline or SSRIs like fluoxetine)
* Anyone on hormone replacement therapy
* Anyone taking blood pressure medication (such as linosipril)
* Anyone with a known allergic reaction
* Any chronic conditions, including oncological and psychiatric disorders

Primary outcomes:
measure: Changes in Measures of C-reactive protein
timeFrame: 12 weeks
measure: Changes in Measures of cortisol
timeFrame: 12 weeks
measure: Changes in Sleep Quality as measured via Fitness trackers and Questionnaires
timeFrame: 12 weeks
Secondary outcomes:
measure: examine the subjective experiences of participants taking the Heights Smart Supplement.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
affiliation: Citruslabs
name: Christopher Hill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06651515: A Study of the Safety and Efficacy of Pancreatic Endocrine Cell Clusters Implanted Into the Omentum of Type 1 Diabetes Patients With Severe Hypoglycemia
Official title: A Phase 1/2 Adaptive Dose Study to Evaluate the Safety and Efficacy of SR-02 Pancreatic Endocrine Cell Clusters Implanted in the Omentum of Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus Type 1
Keywords: severe hypoglycemia
diabetes mellitus
endocrine system diseases
glucose metabolism disorders
Lead sponsor: Seraxis
Sponsor class: INDUSTRY
First posted: 2024-10-21
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety, efficacy and durability of SR-02 administered to the omentum of patients of Type 1 diabetes with severe recurrent hypoglycemia. The study will also help establish the optimal treatment dose. Although this study is open to patients with all HLA or blood types, immunosuppression to prevent rejection will be required in this first in human study.


Eligibility criteria: Key Inclusion Criteria

* Adult 18 to 65 years with a clinical history of T1D
* Diagnosis of T1D at \<40 years of age
* insulin dependence for ≥5 years at pre-screening
* Recurrent severe hypoglycemia
* Willingness to use continuous glucose monitoring

Key Exclusion Criteria

* Use of anti-diabetic agent other than insulin(s) or insulin analog(s) within 3 months of Screening
* Weight loss medication(s) within 3 months of Screening

Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: To investigate the safety and tolerability based on the percentage and relatedness of all treatment emergent adverse events and serious adverse events (TEAEs and SAEs)
timeFrame: day 35 through day 365
measure: The effect on endogenous insulin secretion as assessed by 90-minute MMTT-stimulated C-peptide >0.5 ng/ml (>0.17 nmol/L)
timeFrame: 90 day intervals through day 365
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Shadyside
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06279715: DFI and Aneuploidies
Official title: Evaluation of the Association Between the DNA Fragmentation Index (DFI) and the Frequency of Segmental and Total Aneuploidies
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Embryo Disorder
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Data spreadsheet from October 2020 to December 2023 consisting of more than 800 medical charts.

Brief summary: IVF is the most commonly employed form of assisted reproductive technologies (ART) for the 10-15% of couples who face difficulties becoming pregnant. Many individuals elect to have their IVF-derived embryos analyzed using pregenetic implantation testing for aneuploidies (PGT-A). The use of PGT-A is particularly beneficial for patients at higher risk for aneuploidy, such as those of advanced maternal age and those faced with recurrent pregnancy loss or recurrent implantation failure.

Segmental aneuploidies are generated when a small piece of a chromosome is gained or lost during cell division, resulting in subchromosomal copy number (CN) changes. The frequency of segmental aneuploidies during the cleavage stage varies between studies, from as low as 3.9% to 15% and up to 70 % with no reported correlation with maternal age. This can be explained by the fact that, unlike whole chromosome aneuploidies, segmental aneuploidies most often involve paternally inherited chromosomes.


Eligibility criteria: Inclusion Criteria:

* IVF cycle completed at clinique ovo
* Maternal age between 18 to 43 years included
* PGT-A done on all embryos
* Recent DFI within 1 year of the IVF cycle

Exclusion Criteria:

* Sperm donation

Primary outcomes:
measure: DFI association and aneuploidy
timeFrame: Up to 3 weeks after embryo fertilization
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinique ovo
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Isaac-Jacques Kadoch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00015015: Dichloroacetate Kinetics, Metabolism and Toxicology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lactic Acidosis
Keywords: Dichloroacetate
Chlorinated hydrocarbons
Genetic disease
Toxicology
Biotransformation
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-04-19
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Dichloroacetate (DCA) is a product of water chlorination and a metabolite of certain industrial solvents, thus making it a chemical of environmental concern. However, DCA is also used as an investigational drug for treating various diseases of adults and children, at doses far greater than those to which humans are normally exposed in the environment. Our research involves how DCA is metabolized by healthy adults and by children with a fatal genetic disease, congenital lactic acidosis (CLA) who are treated with DCA.


Eligibility criteria: Children with congenital lactic acidosis Healthy adult volunteers

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Univ. of Florida
state: Florida
Study officials:
References:
Clinical trial NCT05146115: Validation of Modified AST
Official title: Validity and Reliability of the Modified Athletic Shoulder Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Strength
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The participants will have to practice an overhead sport at least 5 hours a week

Brief summary: The objective of the study is the validate and to assess the reliability of a modified version of the Athetic Shoulder Test. The activity of peri-scapular muscles during the realization of the test will be assessed too.

Detailed description: The study will be divided into two sessions. A time of 7-10 days will be provided between the two sessions of tests to limit the influence of sport and training on the results.

Session 1:

* Warm-up
* Realization of the Athletic Shoulder Test (with EMG captors on upper trapezius, lower trapezius and serratus anterior)
* Realization of the modified Athletic Shoulder Test (with EMG captors on upper trapezius, lower trapezius and serratus anterior)

Session 2:

* Warm-up
* Realization of the Athletic Shoulder Test (with EMG captors on upper trapezius, lower trapezius and serratus anterior)
* Realization of the modified Athletic Shoulder Test (with EMG captors on upper trapezius, lower trapezius and serratus anterior)

Eligibility criteria: Inclusion Criteria:

* to practice an overhead sport at least 5 hours a week

Exclusion Criteria:

* no shoulder pain
* no history of shoulder pain
* no history of shoulder surgery
* no scoliosis or lower limb lengths differences

Primary outcomes:
measure: Strength of anteflexors in "I" position
timeFrame: Change from baseline to 10 days
measure: Strength of anteflexors in "Y" position
timeFrame: Change from baseline to 10 days
measure: Strength of anteflexors in "T" position
timeFrame: Change from baseline to 10 days
measure: EMG activity of upper trapezius
timeFrame: during the first session
measure: EMG activity of lower trapezius
timeFrame: during the first session
measure: EMG activity of serratus anterior
timeFrame: during the first session
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Laboratoire d'Analyse du Mouvement Humain
Study officials:
affiliation: ULiège
name: Camille Tooth
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05234515: Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure
Official title: Prospective Bacteriology of sUrGical Site INfection Following Surgery for Intestinal Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Wound Infection
Surgical Site Infection
Bacteria Infection Mechanism
Intestinal Disease
Intestinal Fistula
Lead sponsor: London North West Healthcare NHS Trust
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 21
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: Patients will be recruited from the intestinal failure unit at St Mark's hospital, London North West University Healthcare NHS Trust.

Brief summary: This is a prospective observational study of patients undergoing planned surgery for intestinal failure. The aims of the study are:

* To prospectively characterise preoperative bacterial populations amongst patients undergoing surgery for intestinal failure
* To examine the relationship between preoperative bacteriology and surgical site infection (SSI) in this patient group
* To investigate the effect of surgery and surgical site infection on generic and wound specific quality of life measures


Eligibility criteria: Inclusion Criteria:

* Adults aged \>18 year
* Diagnosis of intestinal failure or enterocutaneous fistula
* Undergoing elective surgery within St Mark's hospital IF unit

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Pregnant

Primary outcomes:
measure: Clinical Surgical Site Infection (SSI)
timeFrame: 0-90 days
measure: Microbiological
timeFrame: 0-90 days
measure: Change in Generic Quality of Life Score
timeFrame: Baseline - 90 days
measure: Change in Wound Specific Quality of Life Score
timeFrame: Baseline - 90 days
measure: Decision conflict
timeFrame: Day 0
measure: Change in Decision Regret
timeFrame: 30 and 90 days
Secondary outcomes:
measure: Length of stay
timeFrame: from day of surgery (day 0)
measure: Complications
timeFrame: 90 days
measure: Abdominal wound healing
timeFrame: 90 days
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: St Marks Hospital
state: London
Study officials:
affiliation: St Marks Hospital & Academic Institute
name: Carolynne F Vaizey
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00394615: Metabolic Imaging Predict Histopathologic Response to Preop ChemoXRT for Locally Advanced Rectal CA
Official title: Metabolic Imaging: Predicting Histopathologic Response to Preoperative Chemoradiotherapy for Locally Advanced Rectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Stanford Cancer Council
First posted: 2006-11-01
Enrollment: 15
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: In this research study of metabolic imaging in locally advanced rectal cancer, we hope to learn whether new medical imaging technology can help predict the response of rectal cancer to preoperative chemotherapy and radiation therapy. Ultimately we hope this information will in the future help us predict which patients will benefit from more or less aggressive initial therapy for their rectal cancer.


Eligibility criteria: Inclusion Criteria:- You must be diagnosed with locally advanced rectal cancer and have chosen treatment with preoperative chemoradiotherapy followed by surgery, which is a standard treatment approach for this disease. Exclusion Criteria:- You are ineligible for this study if you are pregnant or under the age of 18 years old.

Primary outcomes:
measure: To learn whether new medical imaging technology can help predict the response of rectal cancer to preoperative chemotherapy and radiation therapy.
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Albert Koong
role: PRINCIPAL_INVESTIGATOR
References: