louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01121614: Mesenteric Vessel Sealing by Three Instruments
Official title: A Pilot Study to Compare Collateral Damage and Vessel Sealing Ability of LOTUS Ultrasonic Shears, Ethicon Harmonic Scalpel™ and LigaSure™ on Human Mesenteric Blood Vessels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: Harmonic scalpel
ultrasonic scalpel
LOTUS
LigaSure
vessel sealing
burst pressure
collateral damage
Lead sponsor: University Hospital Plymouth NHS Trust
Sponsor class: OTHER
First posted: 2010-05-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Ultrasonic cutting-coagulation devices (UCCD) are surgical instruments which use ultrasonic energy to cut through and coagulate tissue. An Ethicon version (trademarked "Harmonic Scalpel" and "Ultracision") is used in a variety of surgical procedures. Its surgical performance has been directly compared with that of electrically powered diathermy instruments in animal and clinical trials. LOTUS is a company based in Ashburton, Devon, which has developed a UCCD that works in a slightly different way to the Harmonic Scalpel. There are also bipolar feedback diathermy instruments which use electrical energy to seal blood vessels, such as LigaSure. The aim of this project is to obtain data to design a fully powered trial to answer the research question: do LOTUS and Ethicon UCCDs and LigaSure bipolar device reliably seal and divide blood vessels? The investigators will also be examining the degree of collateral tissue damage caused by each instrument.

Hypotheses

* LOTUS UCCD, Ethicon Harmonic Scalpel and LigaSure are equivalent at sealing and dividing mesenteric blood vessels.
* LOTUS UCCD, Ethicon Harmonic Scalpel and LigaSure cause equal amount of collateral damage when sealing and dividing blood vessels.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing laparoscopic or open colorectal resection

Exclusion Criteria:

* Pregnant or lactating women
* Patients under eighteen years of age
* History of coagulation abnormality
* Inability to understand the nature of the study

Primary outcomes:
measure: Bursting pressure of sealed vessel
timeFrame: 1 day
Secondary outcomes:
measure: Success/failure to seal vessel
timeFrame: 1 day
measure: Depth of collateral damage
timeFrame: After histological fixation is complete; within one week
Other outcomes:
Locations:
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
state: Devon
Study officials:
References:
citation: Noble EJ, Smart NJ, Challand C, Sleigh K, Oriolowo A, Hosie KB. Experimental comparison of mesenteric vessel sealing and thermal damage between one bipolar and two ultrasonic shears devices. Br J Surg. 2011 Jun;98(6):797-800. doi: 10.1002/bjs.7433. Epub 2011 Mar 25.
Clinical trial NCT03054714: Long-term Hemodialysis Catheter Removal and Delayed Replacement, Versus Exchange Over a Guidewire to Treat Catheter Related Blood Stream Infection
Official title: Prospective, Randomized Study of Long-term Hemodialysis Catheter Removal, Versus Guidewire Exchange to Treat Catheter Related Blood Stream Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Related Blood Stream Infection
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-02-16
Enrollment: 798
Sex: ALL
Minimum age (years): 14
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, randomized Study of tunneled cuffed hemodialysis catheter removal and delayed replacement, versus exchange over a guidewire to treat catheter related blood stream infection

Detailed description: The aim of this study was to compare the clinical outcomes of catheter-related (CRBSI) managed with two different strategies: Guidewire exchange of the infected catheter with a new one over a guidewire versus catheter removal with delayed replacement.

Eligibility criteria: Inclusion Criteria:

* All patients end stage renal disease on hemodialysis from tunneled cuffed dialysis catheters with suspected catheter-related bloodstream infection with no identifiable infection source except the catheter were included.

Exclusion Criteria:

* metastatic infection,

Primary outcomes:
measure: infection free survival
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Almeida BM, Moreno DH, Vasconcelos V, Cacione DG. Interventions for treating catheter-related bloodstream infections in people receiving maintenance haemodialysis. Cochrane Database Syst Rev. 2022 Apr 1;4(4):CD013554. doi: 10.1002/14651858.CD013554.pub2.
Clinical trial NCT04394195: sFlt1: a Biomarker of Organ Dysfunction in Critically-ill Patients With COVID-19?
Official title: sFlt1: a Biomarker of Organ Dysfunction in Critically-ill Patients With COVID-19?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CORONAVIRUS INFECTIONS
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients with COVID-19 hospitalized in University Hospital of Reims

Brief summary: Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) The management of critically-ill patients with organ failure due to COVID-19 represents a major healthcare burden. While endothelial inflammation has been reported in these patients, the pathophysiological mechanisms remain incompletely elucidated.

Detailed description: Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures. (Limit : 32 000 characters)

The soluble fms-like tyrosine kinase 1 (SFlt1) is the soluble form of VEGF-A receptor 1 (VEGFR1). By linking VEGF-A with a high affinity, sFlt1 blocks the VEGF-A / VEFR1 axis and impairs endothelial homeostasis. Its production increases during inflammation. We hypothesize that sFlt1 is upregulated and correlates with endothelial dysfunction and outcomes in critically-ill patients with COVID-19.

Eligibility criteria: Inclusion Criteria:

* Patient with documented COVID-19 (positive PCR)
* Hospitalized in University Hospital of Reims
* Patient or family who have previously consented

Exclusion Criteria:

* Patient \<18 yo
* Patient not insured under the French social security

Primary outcomes:
measure: Association between concentration of circulating sFlt1 and use of vasopressor
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
citation: Dupont V, Kanagaratnam L, Goury A, Poitevin G, Bard M, Julien G, Bonnivard M, Champenois V, Noel V, Mourvillier B, Nguyen P. Excess Soluble fms-like Tyrosine Kinase 1 Correlates With Endothelial Dysfunction and Organ Failure in Critically Ill Coronavirus Disease 2019 Patients. Clin Infect Dis. 2021 May 18;72(10):1834-1837. doi: 10.1093/cid/ciaa1007.
Clinical trial NCT06719895: Web-Based Newborn Care Education for Primiparous Pregnant Women
Official title: Web-Based Newborn Care Education for Primiparous Pregnant Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Web Based Education
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: For pregnant women expecting their first baby, readiness during pregnancy is an important factor in successfully performing hygienic care for their babies. This study was planned to determine the effect of web-based education on the readiness levels of primiparous pregnant women for newborn hygienic care practices. In this study, the aim was to support pregnant women and mothers after birth in newborn care and to develop their application skills with the web-based education program given to primiparous pregnant women.


Eligibility criteria: Inclusion Criteria:

* Aged between 15 and 19 years
* Being 19 years old and above
* Being literate
* Being primigravida
* Having a single baby (not twins or more)
* Being a volunteer to participate in the study
* Having no health problems for the mother and the baby
* Having a computer, tablet or smart phone and the ability to use it
* Having regular internet access

Exclusion Criteria:

* The mother being 18 years of age or younger
* Being multigravida and/or multiparous
* Having a health problem related to the mother or the baby
* Not having a smart phone or wireless internet during the study period
* Not filling out the survey forms incompletely and not watching videos about hygienic care of the newborn

Primary outcomes:
measure: Mothers' readiness levels for hygienic care of newborns
timeFrame: first test and final test 4 weeks after the first test, one month
Secondary outcomes:
Other outcomes:
Locations:
city: VAN
country: Turkey
facility: Van Yüzüncü Yıl University
state: Tuşba
Study officials:
References:
Clinical trial NCT06227195: Mechanism of IL-10 Pathway-mediated Regulatory B Cell Dysfunction in Osteoarthritis
Official title: Mechanism of IL-10 Pathway-mediated Regulatory B Cell Dysfunction in Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Knee Arthritis
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with knee osteoarthritis come to our hospital

Brief summary: Our previous work has shown that Treg function is impaired in OA patients, but the cause of Treg deficiency has not been investigated. Since Breg has been shown to promote Treg differentiation and tissue repair, it is highly likely that the absence of the immunomodulatory effect of Breg in OA patients leads to impaired Treg differentiation. Based on the above data, we hypothesized that Breg plays a protective role in the course of OA by regulating T cell composition and promoting Treg differentiation through the secretion of anti-inflammatory factor IL-10


Eligibility criteria: Inclusion Criteria:Patients who met the American College of Rheumatology diagnostic criteria for OA

-

Exclusion Criteria:

* Patients with trauma, other forms of arthritis such as rheumatoid arthritis, psoriatic arthritis or spondyloarthritis, and other active inflammatory diseases

Primary outcomes:
measure: Number of Breg
timeFrame: 4 and 8 weeks after DMM
Secondary outcomes:
measure: Cytokine secretion by T cells
timeFrame: 4 and 8 weeks after DMM
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
References:
Clinical trial NCT05113095: A Survey of Darvadstrocel in People with Crohn's Disease
Official title: Postmarketing Surveillance Registry to Evaluate Safety and Efficacy of Darvadstrocel for the Treatment of Complex Perianal Fistulas in Crohn's Disease Patients (J-INSPIRE) (All-case Surveillance)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Crohn's Disease
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-11-09
Enrollment: 275
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with complex perianal fistulas in Crohn's Disease who received Darvadstrocel will be included.

Brief summary: This study is a survey in Japan of Darvadstrocel injection used to treat Crohn's disease people with complicated anal fistula. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects related from Darvadstrocel injection and to check if Darvadstrocel injection improves symptoms of Crohn's disease. During the study, participants with Crohn's disease will take Darvadstrocel injection according to their clinic's standard practice. The study doctors will check for side effects from Darvadstrocel for 36 months.


Eligibility criteria: Inclusion Criteria All patients with complex perianal fistulas in Crohn's Disease who received Darvadstrocel will be included.

Exclusion Criteria None

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 36 Months
measure: Percentage of Participants who Achieve Clinical Response
timeFrame: Baseline, Up to Months 36
measure: Percentage of Participants who Achieve Clinical Remission
timeFrame: Baseline, Up to Months 36
measure: Percentage of Participants who Achieve Combined Remission
timeFrame: Baseline, Up to Months 36
Secondary outcomes:
measure: Percentage of Participants who Occurred Recurrence of Previously Treated Anal Fistulas in Participants who Achieved Clinical Remission at the Previous Visit
timeFrame: Baseline, Up to Months 36
measure: Percentage of Participants with New Perianal Abscess in a Previously Treated Anal Fistula
timeFrame: Baseline, Up to Months 36
measure: Change from Baseline in Perianal Disease Activity Index (PDAI)
timeFrame: Baseline, Up to Months 36
measure: Change from Baseline in Harvey Bradshaw Index (HBI: Simple CDAI Score)
timeFrame: Baseline, Up to Months 36
measure: Health-Related Quality of Life (HRQOL) Measured by EuroQoL Five Dimensions Five Levels (EQ-5D-5L) Scale
timeFrame: Baseline, Up to Months 36
measure: HRQOL Measured by Crohn's Anal Fistula Quality of Life (CAF-QoL) Scale
timeFrame: Baseline, Up to Months 36
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda selected site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04542395: COVID-2019 Testing and Vaccination Among African American and Latinx Public Housing Residents
Official title: Multilevel Participatory Intervention to Reduce Barriers and Promote Social and Behavioral Facilitators of COVID-19 Testing Among African Americans and Latinx Public Housing Residents
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Coronavirus
Lead sponsor: Charles Drew University of Medicine and Science
Sponsor class: OTHER
First posted: 2020-09-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This proposal seeks to enhance acceptability and uptake of COVID-19 testing and vaccination to engage African American and Latinx public housing residents in South Los Angeles. Given the multiple disparities experienced by public housing residents, the investigators will utilize a theoretically-based, multidisciplinary and culturally tailored intervention to reduce barriers and implement innovate strategies to engage this population in the uptake of COVID-19 testing and vaccination.

Detailed description: Through the engagement and empowerment of 15 trained COVID-19 health ambassadors, the investigators will jointly implement and evaluate a theoretically based and culturally-sensitive socio-behavioral intervention that will: a) reduce mistrust, fatalistic beliefs, and related psychosocial barriers that hinder COVID-19 testing and vaccination; b) increase receptivity and willingness for uptake of COVID-19 testing and vaccination; and c) assess perceived impact of psychosocial and health outcomes related to COVID-19 testing and vaccination for 310 African American and Latinx public housing residents.

Eligibility criteria: Inclusion Criteria:

* Identify as Latino/Hispanic or African American/Black
* Reside in one of the six collaborating public housing
* 18 years old and older
* Speak either English or Spanish

Exclusion Criteria:

* Does not self-identify as African American and/or Black
* Under the age of 18
* Unable to speak English or Spanish
* Does not Reside in one of the six collaborating public housing

Primary outcomes:
measure: Prevalence of COVID-19 testing, pneumococcal and influenza vaccinations Using Test History Self-Report
timeFrame: Intervention: 3 months; Follow-up Point: 6 months post-intervention
measure: Percentage of Participants Achieving Decreased Levels of COVID-19 Risk Using the NIH Toolbox Surveys on COVID-19
timeFrame: Intervention: 3 months; Follow-up Point: 6 months post-intervention
measure: Percentage of Participants Achieving Decreased Levels of COVID-19 Mistrust and Barriers Using the NIH Toolbox Surveys on COVID-19
timeFrame: Intervention: 3 months; Follow-up Point: 6 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Housing Authority of Clty of Los Angeles
state: California
Study officials:
affiliation: Charles R. Drew University of Medicine & Science
name: Mohsen Bazargan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01779895: Probiotic Administration and Perennial Allergic Rhinitis
Official title: Effect of Probiotic Lactobacillus Paracasei NCC2461 on House Dust Mite Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhinitis, Allergic, Perennial
Keywords: Dust mite
Perennial allergic rhinitis
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2013-01-30
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
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 evaluate the efficacy of a probiotic strain in improving the quality of life in adult subjects suffering from perennial allergic rhinit.


Eligibility criteria: Inclusion Criteria:

* Adults between 20-65 years old
* Confirmed allergy (allergic rhinitis) to dust mite for more than 2 years, as determined by anamnesis and by a miniRQLQ of ≥ 1
* Positive Skin prick testing measure greater than 3mm wheal diameter to the dermatophagoides pteronyssinus species of house dust mite extract
* Body Mass Index 19-29
* Having obtained his/her informed consent

Exclusion Criteria:

* Anemia
* Allergy to any food or medication
* Asthma
* Family history of congenital immunodeficiency or chronic consumption (more than one week at Screening) of immunosuppressive or anti-inflammatory treatments
* Ongoing treatment with antibiotics or undergoing allergen immunotherapy at Screening
* Consumption of probiotic and other dietary nutritional interventions
* More than 2 drinks/day alcohol consumption or use of illicit drugs
* Pregnant women
* Subjects with expected low compliance
* Blood donation in the past month or planning to donate blood until a month after the end of the study
* Currently participating or having participated in another interventional clinical trial during the last four weeks prior to the beginning the study

Primary outcomes:
measure: Quality of life, measured by a validated mini rhinoconjunctivitis quality of life questionnaire (MiniRQLQ)
timeFrame: 8 weeks
Secondary outcomes:
measure: Level of pro-inflammatory cytokines in ex-vivo stimulated whole blood cells
timeFrame: Measured 3 times: at the start of product intake, after 4 weeks and after 8 weeks
measure: Basophil activation in ex-vivo stimulated whole blood cells
timeFrame: Measured 3 times: at the start of product intake, after 4 weeks and after 8 weeks
measure: Total Nasal Symptom Score (TNSS), Total Ocular Symptom Score (TOSS), Medication score
timeFrame: Measured weekly for the 8 weeks of product intake
measure: Level of Specific Immunoglobulin E
timeFrame: Measured 2 times: at the start of product intake and after 8 weeks
measure: Frequency of adverse events
timeFrame: during the 8 weeks of product intake
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Metabolic Unit, Nestlé Research Centre
Study officials:
affiliation: Nestlé Research Centre
name: Maurice Beaumont, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03252795: Uterus Transplantation From a Multi-organ Donor
Official title: Uterus Transplantation From a Multi-organ Donor: A Prospective Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility, Female
Mayer Rokitansky Kuster Hauser Syndrome
Keywords: Infertility, female
Mayer Rokitansky Kuster Hauser Syndrome
Transplantation; Deceased donor
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Uterus transplantation: screening, in vitro fertilization \[IVF\] treatment to be able to freeze embryos, uterus transplantation, pregnancy and afterwards removal of the uterus.


Eligibility criteria: Inclusion Criteria:

* Female with Maier-Rokitansky-Kuster-Hauser syndrome
* Mucosal neovagina of at least 7 cm
* In a stable relationship for at least 1 year
* Child wish
* Good renal function (and presence of both kidneys)
* Psychologically stable and compliant
* At least 8 frozen embryos after IVF/intracytoplasmic sperm injection \[ICSI\]
* Living in Belgium and a good health insurance
* Willing and able to provide informed consent

Exclusion Criteria:

* Major pelvic surgery
* Major chronic illnesses
* Other risk factors or malignancies
* BMI \> 30

Primary outcomes:
measure: Survival of the uterus 1 year after transplantation
timeFrame: 1 year after uterus transplantation
measure: Complications after uterus transplantation
timeFrame: As long as the uterus remains in situ (the uterus will be removed within one year after delivery)
measure: Ongoing pregnancy rate
timeFrame: 4 weeks after embryo transfer
measure: Take home baby rate
timeFrame: 9 months after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital - Women's Clinic
Study officials:
References: