louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04824833: Effects of US-guided SAPB During Breast Surgery
Official title: The Effects of Ultrasound-guided Serratus Anterior Plane Block on Intraoperative Opioid Consumption and Hemodynamic Stability During Breast Surgery: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodynamic Instability
Opioid Use
Block
Breast Cancer
Keywords: hemodynamics
serratus anterior plane block
opioid consumption
breast surgery
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The serratus anterior plan (SAP) block is a technique that has recently gained popularity in the context of breast surgery. SAP block resulted in better hemodynamic stability, early ambulation and shorter hospital stay, as well as hospital costs for postoperative breast patients.

We aimed to investigate the effects of the serratus anterior plane block in women undergoing breast surgery, in the intraoperative period.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-75,
* ASA I-II-III risk group
* Patients who underwent breast surgery under general anesthesia, who underwent serratus anterior plan block for analgesia, or who were provided analgesia with conventional methods
* Patients whose informed consent was read and whose consent was obtained

Exclusion Criteria:

* who do not want to participate in the study,
* ASA IV-V patients

Primary outcomes:
measure: hemodynamic stability
timeFrame: during surgery
measure: opioid consumption
timeFrame: during surgery
Secondary outcomes:
measure: emergence time
timeFrame: end of the surgery
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University medicine faculty
state: Kozlu
Study officials:
References:
citation: Baytar C, Aktas B, Aydin BG, Piskin O, Cakmak GK, Ayoglu H. The effects of ultrasound-guided serratus anterior plane block on intraoperative opioid consumption and hemodynamic stability during breast surgery: A randomized controlled study. Medicine (Baltimore). 2022 Sep 2;101(35):e30290. doi: 10.1097/MD.0000000000030290.
Clinical trial NCT04137133: Patienthèque of Finisterian (South of Brittany) Children With Cystic Fibrosis in the Time of Precision Medicine
Official title: Patienthèque of Finisterian (South of Brittany) Children With Cystic Fibrosis in the Time of Precision Medicine.Descriptive Monocentric Study for Identification and Validation of Biomarkers Predictive of Clinical Evolution
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 20
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to evaluate the relevance of Porphyromonas as a biomarker predicting the risk of P. aeruginosa primocolonization in children form 0 to 18 years old with cystic fibrosis.

Detailed description: This is a monocentric study in 3 phases:

* Pre-inclusion: at the first visit to the CRCM (support for a positive screening confirmed by sweat test and genotyping CFTR)
* Inclusion: possible between the 2nd visit to the CRCM (about 2 months old) and the 6th month
* Follow-up: up to 36 months old. The pace of visits will be based on the usual follow-up rate of CF infants Clinical and paraclinical data and samples will be collected as part of the usual follow-up of CF children. Inclusions and follow-up visits will be carried out at the Roscoff CRCM as well as respiratory explorations and biological samples. Dermatological and odontological follow-ups will be scheduled for each patient at the rate of an annual visit to the CHRU in Brest in the relevant departments.

Eligibility criteria: Inclusion Criteria:

* Newly screened infants with a confirmed diagnosis of cystic fibrosis in its classic form (clinical symptoms and two positive sweat tests and/or two mutations of the cftr gene from Class I to III)
* Children free of any colonization with P. aeruginosa
* Affiliation with the social security system
* Consent signed by the holders of parental authority or the sole parent holding parental authority

Exclusion Criteria:

* Children colonized with P. aeruginosa according to the cytobacteriological examination and / or molecular test of sputum or pharyngeal specimens
* Children grafted
* Children not affiliated to a social security scheme or not entitled to
* Children whose parent (s) are (are) minor (s)
* Children whose holders of parental authority do not master the French language
* Refusal to participate in the study

Primary outcomes:
measure: Presence of P. aeruginosa in bacterial sputum cultures in one of bronchial secretions sample
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Roscoff
country: France
facility: Fondation Ildys
Study officials:
References:
Clinical trial NCT04092933: Perioperative Risk Calculator
Official title: Machine-learning Model for Perioperative Risk Calculation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Perioperative/Postoperative Complications
Keywords: machine learning
decision support
risk calculator
anesthesia
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Health Information Management, Belgium
First posted: 2019-09-17
Enrollment: 175559
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent surgical interventions with general or regional anesthesia at Klinikum rechts der Isar, Munich after the implementation of an electronic patient data management system in May 2014

Brief summary: The aim of this project is to develop a machine-learning model for calculating the risk of postoperative complications. In addition to the data collected during the premedication, the model will include all intraoperative values recorded in the Patient Data Management System (PDMS), which include not only vital and respiratory parameters, but also medication and doses, intraoperative events and times. Postoperative complications are defined according to their severity according to the Clavien-Dindo score (Dindo, Demartines et al., 2004) and are collected from the data available in the health information system (HIS).

The machine-learning model is created using an extreme-gradient boosting algorithm which has been updated with new data from the year 2021 to ensure accuracy of the model.


Eligibility criteria: Inclusion Criteria:

* all patients who underwent surgery with anesthesia

Exclusion Criteria:

* none

Primary outcomes:
measure: postoperative complications
timeFrame: 30 days
Secondary outcomes:
measure: in-hospital mortality
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01140633: Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda
Official title: Novel Measures and Theory of Pediatric Antiretroviral Therapy Adherence in Uganda
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-infection/Aids
Keywords: HIV/AIDS
pediatric
wireless adherence monitoring
HIV Infections
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Mbarara University of Science and Technology
First posted: 2010-06-09
Enrollment: 46
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: young children receiving HIV antiretroviral therapy in a rural African setting

Brief summary: Current measures of adherence detect problems weeks to months after they occur. Because the HIV virus rapidly begins replicating and mutating in the absence of effective antiretroviral therapy, treatment failure may develop before an intervention can be deployed. Real-time objective adherence monitoring could redirect efforts from a reactive response to the proactive prevention of treatment failure. Because adherence is so closely associated with viral suppression, accurate adherence monitoring could also strategically limit viral monitoring only to those patients at a defined risk for viral rebound.

This observational study is assessing a wireless adherence monitoring device and mobile phone-based adherence data collection among caregivers of children under the age of ten years in Mbarara, Uganda. It involves both quantitative and qualitative measures of the feasibility and acceptability of these measures, as well as circumstances of adherence lapses and other individual and cultural factors affecting adherence. The qualitative data will be used to explore models of adherence behavior, which will likely include the child-caregiver dynamic, the child's mental and physical health, and social support mechanism.

Detailed description: See above.

Eligibility criteria: Inclusion Criteria:

* age 1 to 10 years
* HIV-infected, meeting Ugandan criteria for antiretroviral therapy
* living within 30 km of Mbarara, Uganda

Exclusion Criteria:

* lack of mobile-phone reception

Primary outcomes:
measure: Distribution of adherence
timeFrame: Monthly adherence levels will be determined over the six-month study period.
Secondary outcomes:
measure: Feasibility and acceptability of wireless adherence measures
timeFrame: Assessments will be made a the one-month time point.
measure: Model of adherence behavior
timeFrame: Data collected at baseline and during adherence interruptions will be analyzed at the end of the six-month study period.
Other outcomes:
Locations:
city: Mbarara
country: Uganda
facility: Mbarara University Teaching Hospital
Study officials:
affiliation: Massachusetts General Hospital
name: Jessica E Haberer, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05021133: Tele-Navigation of Lung Cancer Screening (Tele-Navi LCS)
Official title: Tele-Navigation of Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: lung cancer
cancer screening
health informatics
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2021-08-25
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Adherence to annual follow up is critical to achieving mortality benefits and optimizing cost-effectiveness of lung cancer screening (LCS). However, adherence to LCS follow-up in the real world is suboptimal. Using telehealth, the investigators will co-create Tele-Navigation of Lung Cancer Screening with patients and LCS stakeholders as an intervention to promote adherence of follow-up LCS. The investigators will then implement the Tele-Navi LCS intervention to a pilot sample of patients and evaluate its feasibility in the primary care setting. The investigators will measure the number of patient participants who completed Tele-Navi LCS and follow-up LCS within 180 days from Tele-Navi LCS.


Eligibility criteria: Inclusion Criteria:

* Is eligible for LDCT for LCS follow-up
* Has technology to complete study activities (e.g., video call visit)
* English speaker
* Has undergone LCS at UMMH
* Is overdue for LDCT follow-up

Exclusion Criteria:

* Has previous diagnosis of lung cancer
* Has active cancer diagnosis
* Is a nursing home or group care resident
* Is pregnant

Primary outcomes:
measure: Completion of Tele-Navi LCS
timeFrame: 30 days
Secondary outcomes:
measure: Completion of Follow-up LCS
timeFrame: 180 days
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Mayuko Ito Fukunaga, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04966533: Characterize Metzker Pigmentary Disorders
Official title: Characterize Metzker Pigmentary Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pigment Dispersion
Mosaicism
Keywords: Metzker pigmentary disorder
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 74
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children coming at the pediatric dermatology consultation with a Metkzer pigmentary disorder between 2005 and 2021

Brief summary: Metzker pigmentary disorders are frequent cause of consultation in pediatric dermatology. The investigators can describe 4 patterns. They must be differentiated from mosaicisms because they aren't associated with neurologic disorders and don't require any follow up.


Eligibility criteria: Inclusion criteria:

* Metzker pigmentary disorder, age between birth and 18 years old

Exclusion criteria:

* None

Primary outcomes:
measure: Metzker pigmentary disorder pattern
timeFrame: 1 day
Secondary outcomes:
measure: Rate of Evolution
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospitals of Montpellier
name: Didier BESSIS, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04910633: Medical Treatment of Solid Tumors at the Lyon University Hospital Cancer Institute During the First Wave of COVID-19 in France: A Conservative Approach
Official title: Medical Treatment of Solid Tumors at the Lyon University Hospital Cancer Institute During the First Wave of COVID-19 in France: A Conservative Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Solid Tumor
Covid19
Keywords: COVID-19
Cancer
Solid Tumor
Qualitative study
First pandemic wave
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a LUHCI cancer code created after 2015 and a LUHCI COVID-19 code created between March 2020 and May 2020.

Brief summary: An article to present how cancer patients were taken in charge at Lyon University Hospital Cancer Institute (France) during the first peak of the COVID-19 pandemic between March and May 2020 is under writing.

It will present strategies that were set-up to avoid cross-contamination between patients and caregivers, patients treatment adaptation (timing, dosage,..) and how consultations, multidisciplinary team meetings, surgical procedures and clinical trials were impacted.

Part of this article will also illustrate the characteristics of patients with a solid tumor(s) that have been hospitalized during this timeframe for the COVID-19. How cancer type and stage affect Covid severity and mortality.will be described for a small sample of patients (44). These qualitative figures will be compared to literature current state of the art.


Eligibility criteria: Inclusion Criteria:

* Patients with a LUHCI code created after 2015 and a LUHCI COVID-19 code created between March 2020 and May 2020.

Exclusion Criteria:

* Patients who did not allow the reuse of their medical file data for research related to COVID-19-

Primary outcomes:
measure: Illustration of the repartition of COVID+ patient severity (Low/Medium/Severe status) depending on cancer nature, stage and patient age.
timeFrame: At the end of Month 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Lyon University Hospital Cancer Institute
Study officials:
References:
Clinical trial NCT01522833: Non Small Cell Lung Cancer Patients Treated With Erlotinib Six Months or Longer
Official title: Non-Small-Cell Lung Cancer Patients Treated With Erlotinib Six Months or Longer: Demographics, Treatment and Outcome Characteristics of Patient Cases in a Community-Based Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Keywords: NSLCL
Erlotinib
Tarceva
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2012-02-01
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: EGFR-wt and EGFR mutation positive advanced NSCLC patient cases with an erlotinib-treatment duration of six months or longer (as 2nd/3rd line and/or maintenance single-agent therapy) in a community-based setting

Brief summary: With roughly 80% of cancer patients receiving their oncology care in the community setting, the investigators are proposing to sample from a community-based center to evaluate the percentage of epidermal growth factor receptor (EGFR)-wild type patients that gain benefit from erlotinib and assess the clinical characteristics that are associated with erlotinib-responders. Additionally, biopsy specimens from enrolled patient cases that are EGFR-wt will be evaluated via exploratory genetic analysis for correlated markers.


Eligibility criteria: Inclusion Criteria:

* Patients must have had NSCLC.
* Patients must have received erlotinib (single-agent) for six months or longer for NSCLC in the second/third line setting or as maintenance therapy.
* Patients must have tissue available for EGFR-mutation status testing (if not previously performed) or EGFR-mutation status test results available.
* Patients must have tissue available for exploratory genetic analysis.
* Patients must have all clinical information, treatment response data and outcomes data available for review.
* Patients must be deceased.

Primary outcomes:
measure: demographics
timeFrame: 24 months
measure: treatment characteristics
timeFrame: 24 months
measure: outcome characteristics
timeFrame: 24 months
Secondary outcomes:
measure: Biomarker characteristics
timeFrame: 24 months
measure: Exploratory genetic analysis
timeFrame: 24 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: David R Spigel, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06195033: Randomized Controlled Clinical Trial of Internal Fixation of Intertrochanteric Fractures of Femur Guided by Conventional Versus IF-AI Artificial Intelligence Program
Official title: Randomized Controlled Clinical Trial of Internal Fixation of Intertrochanteric Fractures of Femur Guided by Conventional Versus IF-AI Artificial Intelligence Program
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hip Fractures
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 132
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our team has developed an AI software to guide the surgical protocol for femoral intertrochanteric fractures. This is a prospective randomized controlled clinical study that will include patients with femoral intertrochanteric fractures combining medial posterior and lateral wall fractures, and will randomly divide the patients into a traditional surgical protocol group and an AI-guided surgical protocol group. The efficacy and safety indexes such as operation time, blood loss, operation cost, infection rate, hospitalization time, postoperative pain score, fracture healing time, internal fixation failure rate and mortality rate were compared between the two groups to verify the efficacy and safety of AI-guided surgical treatment plan.


Eligibility criteria: Inclusion Criteria:

1. Over 60 years old, male or female.
2. Osteoporosis intertrochanteric fracture, which met the diagnostic criteria of X-ray intertrochanteric fracture, and osteoporosis T-value \<2.5.
3. Patients with 1mm resolution CT imaging data.
4. Willing to participate in the project, sign the informed consent, and be able to complete the follow-up work.

Exclusion Criteria:

1. Patients with pathological fractures, old fractures, stress fractures, and periprosthesis fractures;
2. Patients lacking 1mm resolution CT imaging data;
3. Severe malnutrition, heavy smoking, alcoholism and other systemic conditions affect fracture healing;
4. Patients with severe medical diseases that cannot be operated on;
5. Patients participating in other clinical studies.

Primary outcomes:
measure: Fracture healing situation 36 weeks after surgery
timeFrame: 36 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: