louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05535309: Establishment of Risk Factors Model of Drug-induced Coagulation Disorder Caused by Cefoperazone Sulbactam Sodium
Official title: Epidemiological Study on Drug-induced Coagulation Disorder Caused by Cefoperazone Sulbactam Sodium and Construction of Prediction Model
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Risk Factors
Keywords: Coagulation disorder
Epidemiological study
Risk factors
Building models
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators included inpatients who were hospitalized from January 1, 2018 to December 30, 2021. The patients must be over 18 years old and take cefoperazone sulbactam sodium. Patients with underlying diseases that may affect the results were excluded and divided into exposure group and control group for study.

Brief summary: The incidence rate of drug-induced blood diseases accounts for about 10% of all drug-induced diseases, most of which are serious at the time of onset, and the mortality rate can be as high as 32.5%. In this study, cefoperazone sulbactam sodium, which is commonly used in clinic, was selected as the target drug, and the epidemiological characteristics of drug-induced coagulation dysfunction and the construction of risk factor models were studied by single factor and multiple factor Logistic regression analysis.

Detailed description: Investigators selected inpatients from Qianfoshan Hospital of Shandong Province from January 1, 2018 to December 30, 2021, extracted the cohort according to the inclusion and exclusion criteria, and divided it into exposure group and control group to find out the risk factors of cefoperazone sulbactam sodium causing coagulation disorders, and build a risk factor model of drug-induced coagulation disorders caused by cefoperazone sulbactam sodium.

Eligibility criteria: Inclusion Criteria:

All inpatients who used cefoperazone sulbactam sodium during hospitalization;

* Hospital stay ≥ 48h
* Age ≥ 18 years old

Exclusion Criteria:

* Age \< 18 years
* Severe liver and kidney dysfunction
* Patients with vitamin K deficiency
* Patients with hematological diseases
* Patients with advanced malignant tumor or mental disease
* Patients with incomplete clinical data

Primary outcomes:
measure: Coagulation disorder
timeFrame: Through study completion,up to half a year.
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Xiao Li,MD
state: Shandong
Study officials:
References:
Clinical trial NCT06124209: Use of Fibrin Sealant Patch for Vein Anastomosis During Deceased Donor Liver Transplantation- Randomized Clinical Trial
Official title: Use of Fibrin Sealant Patch for Vein Anastomosis During Deceased Donor Liver Transplantation- Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Liver Transplant; Complications
Keywords: tachosil
liver transplantation
vena cava inferior anastomosis
fibrin sealant
hemostasis
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

Brief summary: The study aims to evaluate the effect of the hemostatic matrix with fibrinogen and thrombin (TachoSil®) on vena cava inferior anastomoses during liver transplantation from a deceased donor.

The research comprises two groups: an experimental cohort with patients receiving a hemostatic matrix of fibrinogen and thrombin on the anastomotic line of the inferior vena cava, and a control cohort utilizing hemostasis without matrix sealent. The study involves a total of 170 participants, evenly distributed with 85 patients in each group.

Detailed description: Studies have shown that materials containing fibrin shorten the time to hemostasis in the case of planned liver resection, but did not show a significant effect on the occurrence of postoperative bleeding. The aim of the study is to supplement knowledge about hemostatic matrices in liver transplantation, which will be used for the inferior vena cava anastomosis.

The study aims to evaluate the effect of the hemostatic matrix with fibrinogen and thrombin (TachoSil®) on vena cava inferior anastomoses during liver transplantation from a deceased donor.

The research comprises two groups: an experimental cohort with patients receiving a hemostatic matrix of fibrinogen and thrombin on the anastomotic line of the inferior vena cava, and a control cohort utilizing hemostasis without matrix sealent. The study involves a total of 170 participants, evenly distributed with 85 patients in each group.

Eligibility criteria: Inclusion Criteria:

* age over 18
* elective liver transplantation
* informed consent to participate in the study

Exclusion Criteria:

-decision to use packing during liver transplantation (bail out strategy)

Primary outcomes:
measure: Significant postoperative bleeding
timeFrame: 10 days
Secondary outcomes:
measure: Postoperative complication
timeFrame: 10 days
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of General Transplant and Liver Surgery
state: Mazovian Voivodeship
Study officials:
affiliation: Medical University of Warsaw
name: Paweł Rykowski, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05192109: Study 2: Learning New Words From Overhearing in Children With Autism Spectrum Disorder (ASD)
Official title: Study 2: Learning New Words From Overhearing in Children With Autism Spectrum Disorder (ASD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: New York University
Sponsor class: OTHER
Collaborators: name: Emerson College
First posted: 2022-01-14
Enrollment: 342
Sex: ALL
Minimum age (years): 18
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this research is to explore abilities to learn word meanings from overheard conversations in children with ASD (and, as a control, typically developing children).

Specific Aim 2 (Experiment 2): Determine whether children with ASD can learn from addressed and overheard teaching via videoconferencing. The investigators will use a similar procedure to Study 1, except that both overheard and directed teaching will take place on video.


Eligibility criteria: Inclusion Criteria:

children with or without a diagnosis of ASD between 18 to 71 months of age

Exclusion Criteria:

native language is not English born premature (\< 36 weeks) has uncorrected hearing or vision impairments has developmental disorders or medical conditions other than ASD that affect language or cognition (excepting psychiatric conditions often comorbid with ASD such as ADHD) has a history of photosensitive epileptic seizures

Primary outcomes:
measure: Proportion of Time During Which Children's Eye Gaze is Directed Toward the Target Object
timeFrame: immediately after viewing 3-minute interaction
measure: Proportion of Time During Which Children's Eye Gaze is Directed Toward the Target Object
timeFrame: 5 minutes after viewing interaction
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Emerson College
state: Massachusetts
city: New York
country: United States
facility: New York University
state: New York
Study officials:
References:
Clinical trial NCT04332809: A Randomized Controlled Trial on Wound Irrigation in Open Appendectomy.
Official title: A Randomized Controlled Trial on Irrigation of Open Appendectomy Wound With Gentamicin- Saline Solution Versus Saline Solution for Prevention of Surgical Site Infection.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Appendicitis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 208
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A large retrospective study compared wound irrigation with antiseptic solution, with antimicrobial agent, and with normal saline in patients undergoing open appendectomy and concluded an evident superiority of antibiotic wound irrigation over both normal saline and antiseptic solution.

The present trial aimed to assess the efficacy of layer-by-layer wound irrigation with gentamicin-saline solution versus saline solution in prevention of incisional SSI after open appendectomy for acute appendicitis. We postulated that irrigation of every layer of the surgical wound separately would help reduce the incidence of incisional SSI by eradication of bacterial contamination of each layer which may occur during delivery, manipulation, and removal of the inflamed appendix through the McBurney's incision.


Eligibility criteria: Inclusion Criteria:

* The study included patients of both genders aging between 16 and 65 years who presented to the emergency department with acute appendicitis. Acute appendicitis was diagnosed by clinical examination and intraoperative findings and the diagnosis was confirmed with histopathologic examination of the removed appendix.

Exclusion Criteria:

* Patients with appendicular mass, appendicular abscess, appendicitis associated with generalized peritonitis, acute abdomen due to other causes as revealed intraoperatively, patients with normal appendix as revealed intraoperatively and after histopathologic examination, patients taking long course of steroid therapy or immunosuppressive treatment, and patients unwilling to participate in the trial.

Primary outcomes:
measure: Incidence of surgical site infection
timeFrame: 6 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh H Emile, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00180609: SCANCAP Scandinavian Automatic Capture Study
Official title: Scandinavian Automatic Capture Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bradycardia
Lead sponsor: Guidant Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: The primary objective of this study is to document the success rate of the automatic threshold testat pre-discharge in a normal pacemaker patient population implanted with Guidant Insignia Ultra or AVT .

Detailed description: Currently the optimal programming of the pacemaker output considers both pacemaker efficiency (prolonging battery longevity) and patient safety (adequate safety margin). A decrease in the programmed output can be used to increase the projected battery life or to eliminate diaphragmatic or pectoral muscle stimulation. An increase in programmed output may be required to account for increasing thresholds after lead implantation. The ability of an implanted pacemaker to automatically adjust the ventricular output above the pacing threshold while maintaining the appropriate safety margin has been explored since the early 1970s. The Automatic capture feature in the INSIGNIA I Ultra/AVT pacemaker automatically adapts the ventricular pacing output to ensure capture of the ventricle while optimizing the output voltage. The primary objective of this study is to document the success rate of the automatic threshold test in a normal pacemaker patient population by following normal pacemaker follow-up results for 1 year.

Eligibility criteria: Inclusion Criteria:

* Suitable candidate for a INSIGNIA I Ultra or Insignia I AVT pacemaker (with a ventricular lead). Availability for follow-up at the centre. Willingness to participate in this study. Age 18 or above, or of legal age to give informed consent as specified by national law.

Exclusion Criteria:

* Inability or refusal to sign the Patient Informed Consent. Known pregnancy. Presence of mechanical tricuspid valve

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Viborg
country: Denmark
facility: Medicinsk Afdeling, Sygehus Viborg
Study officials:
affiliation: Medicinsk Afdeling, Sygehus Viborg, Viborg, Denmark
name: Per D Christensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06518109: Caregivers of Children With Autism Spectrum Disorder
Official title: Caregiver's Burden and Their Relationship to Physical Activity, Exercise Self-Efficacy, Perceived Exercise Benefits and Barriers in Caregivers of Children With Autism Spectrum Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Caregiver Burden
Exercise
Physical Activity
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population were being over 18 years of age, caring for a CwASD for at least 1 year, the child with autism being 18 years of age or younger, being an informal caregiver, and the caregiver being the person with primary responsibility for caring for the CwASD in the family.

Brief summary: This study aims to examine the relationship between caregiving burden and physical activity, exercise self-efficacy, and perceived exercise benefits and barriers in caregivers of Caregivers of children with autism spectrum disorder (CwASD).The study population consisted of primary caregivers of a CwASD for at least 1 year. Caregiving burden was assessed using the Zarit Caregiver Burden Scale, physical activity using the International Physical Activity Questionnaire-Short form (IPAQ-SF), exercise self-efficacy using the Exercise Self-Efficacy Scale, and perceived exercise benefit using the Exercise Benefits/Barriers Scale. The relationship between caregiver burden and other parameters was analysed.


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age,
* Caring for a CwASD for at least 1 year,
* The child with autism is 18 years old or younger,
* being an informal carer,
* The caregiver is the person with primary responsibility for the care of the CwASD in the family.

Exclusion Criteria:

* People over the age of 65,
* Those without a diagnosed chronic physical condition leading to disability,
* Those caring for more than one CwASD, another disabled person, an older adult or someone needing care

Primary outcomes:
measure: The Zarit Caregiver Burden Scale
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: University of Health Sciences
Study officials:
References:
Clinical trial NCT03767309: Management of Miller Class I & II Gingival Recession
Official title: Management of Miller Class I & II Gingival Recession Using Conventional Versus Abrasive De-epithelization of Palatal Graft
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Recession
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-12-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Management of Miller class I \& II gingival recession using coronally advanced flap combined with conventional de-epithelialized free gingival graft versus coronally advanced flap combined with abrasive de-epithelized connective tissue graft Null hypothesis: In patients with Miller class I and II gingival recession, there is no difference between coronally advanced flap with conventional de-epithelialized free gingival graft and coronally advanced flap with abrasive de-epithelized connective tissue graft in recession depth reduction.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Systemically healthy patients.
* Miller's Class I and II recession defects with recession depth ≥ 2mm.
* Presence of identifiable cemento-enamel junction (CEJ).
* Clinical indication and/or patient request for recession coverage.
* Smoking ≤ 10 cigarettes/day.
* Cooperative patients able and accept to come for follow up appointments.

Exclusion Criteria:

* Pregnant females.
* Smoking ˃ 10 cigarettes/day.
* Contraindication for periodontal surgery.
* Patients with poor oral hygiene.
* Recession defects associated with caries or restoration as well as
* Teeth with evidence of a pulpal pathology
* Molar teeth

Primary outcomes:
measure: Direct Post-operative pain
timeFrame: 7 days
measure: Indirect Post-operative pain
timeFrame: 7 days
Secondary outcomes:
measure: Complete Root Coverage
timeFrame: 6 months
measure: Recession depth.
timeFrame: 6 months
measure: Gingival Recession Width
timeFrame: 6 months
measure: Width Of Keratinized Gingiva
timeFrame: 6 months
measure: Root Coverage Esthetic Score
timeFrame: 6 months
measure: Gingival thickness
timeFrame: 6 months
measure: Surgical chair time
timeFrame: at the time of surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00185809: Scintigraphic Assessment of I- Transport in Metastatic Breast Cancer and Evaluation of I31I Ablative Therapy: (Part I) Radioiodide Imaging Study
Official title: Scintigraphic Assessment of I- Transport in Metastatic Breast Cancer and Evaluation of I31I Ablative Therapy: (Part I) Radioiodide Imaging Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
First posted: 2005-09-16
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligibility criteria include histological proof of invasive breast cancer and current radiological evidence of metastatic disease.

Brief summary: The purpose of this study is to examine breast cancers that express the protein (NIS) that may be found in malignant breast tissues and to evaluate proteins found in blood and their relationship to NIS, to test whether iodide can be concentrated by breast cells to possibly treat some breast cancers with radioactive iodine, and to calculate the amount of radioactive iodine entering breast cancer cells, how long your cancer retains the agent as well as how much is taken up by other organs, particularly the thyroid gland.

Detailed description: To demonstrate iodide uptake capacity of breast cancer metastases by imaging women with iodide radioisotope (123I) and calculating potential ablative dose of radioactive iodide (131I).

Eligibility criteria: Inclusion Criteria:- Only women diagnosed with breast cancer

* 18 years of age or older
* From whom informed consent can be obtained
* Patient is able to provide a fluid (e.g. cyst fluid)
* Patient with blood test that shows protein may allow iodide to accumulate in breast tissue
* Patient who's breast cancer cells accumulated I123 and held on to it for 24 hours Exclusion Criteria:- Males
* Children

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Irene L. Wapnir
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05043909: The Effects of Virtual Reality and Augmented Reality Training System on Elderly Oral Care Skill for Oral Hygiene and Nursing Students
Official title: Virtual Reality Training System on Oral Health Care for Dependency Elderly in Oral Hygiene Students: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Education
Keywords: Dependency
Elderly
Medical Education
Oral Hygiene
Virtual Reality
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Virtual reality (VR) has been proposed as a promising technology for education since the combination of immersive and interactive features enables experiential learning. The study aimed to evaluate the effectiveness of VR-based training on oral health care for dependency elderly among oral hygiene students.

Detailed description: A randomized controlled trial was conducted. Overall, the study recruited students from third grade of Department of Oral Hygiene students in Kaohsiung Medical University during 2021. The participants were randomly assigned to virtual-reality experimental (EG; n = 11) and control (CG; n = 12) groups. The students in EG received a 2-hour VR training for elderly oral health care at 2-week (Time 2), 4-week (Time 3) and 6-week (Time 4) follow-ups. Each student collected the data by a self-administrated questionnaire before and immediately after each of the intervention. Linear regression in generalized estimating equations (GEE) compare the differences between both groups.

Eligibility criteria: Inclusion Criteria:

* third grade of Department of Oral Hygiene students in Kaohsiung Medical University during the 2021 academic semester
* Participants have to take both the courses of 'Basic Medical Nursing Care' and 'Oral Health Care for Community People and Long-term Care Residents' before intervention.

Exclusion Criteria:

* none

Primary outcomes:
measure: Elderly oral care-related knowledge
timeFrame: Change from Baseline knowledge at 2-, 4-, 6-week follow-ups after the interventions
measure: Attitude toward elderly oral care
timeFrame: Change from Baseline attitude at 2-, 4-, 6-week follow-ups after the interventions
measure: Self-efficacy of elderly oral care
timeFrame: Change from Baseline self-efficacy at 2-, 4-, 6-week follow-ups after the interventions
measure: Intention to elderly oral care behaviors
timeFrame: Change from Baseline intentions at 2-, 4-, 6-week follow-ups after the interventions
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
state: San Min District
Study officials:
affiliation: Kaohsiung Medical University
name: Hsiao-Ling Huang
role: PRINCIPAL_INVESTIGATOR
References: