louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04955210: A Multi-Center Data System and Collaborative Network in China for Severe Infection and Sepsis Children
Official title: Establishment of a Multi-Center Big Data System for Severe Infection and a Collaborative Network on Sepsis in Chinese Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Severe Sepsis
Keywords: Sepsis
Critical Illness
severe infection
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 5000
Sex: ALL
Minimum age (years): 29
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children hospitalized in PICU of Children's Hospital of Fudan University from April 2021 to April 2025

Brief summary: 1. To research the current situation of severe infection in children in China, and to investigate the incidence, prognosis and disease burden of severe infection in children in different regions of China. 2. Establish the risk prediction model and diagnosi model of severe infection in children, and verify the accuracy of the model in multi-center; 3. To study the effectiveness and safety of different treatments in real diagnosis and treatment, and to evaluate the efficacy of subgroups under different ages and high risk factors.

Detailed description: 1.Children between 0 and 18 years old. 2.Severe pneumonia and/or sepsis.Patients were included who meet the guidline for diagnosis and treatment of community-acquired pneumonia in Children (2019) issued by the National Health Commission of the people's Republic of China and/or who meet the International Guide to the 2020 campaign to Save sepsis: management of septic shock and sepsis-related organ dysfunction in children. 3.notifiable infectious diseases.4.The researcher believes that he is not suitable to participate in other situations in this study.5.Participants in other clinical trials in the same period.

Eligibility criteria: Inclusion Criteria:

1. Children between 0 and 18 years old.
2. Severe pneumonia and/or sepsis.

Exclusion Criteria:

1. notifiable infectious diseases.
2. The researcher believes that he is not suitable to participate in other situations in this study.
3. Participants in other clinical trials in the same period.

Primary outcomes:
measure: survival rate
timeFrame: within 28 days after they discharged from PICU
Secondary outcomes:
measure: length of stay in PICU
timeFrame: within 28 days after they discharged from PICU
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: The Children's Hospital of Fudan University
name: Guoping Lu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05600010: Detection of Microplastics in Cardiac Surgery Patients
Official title: Detection of Microplastics in Cardiac Surgery Patients: Its Metabolic Pathways and Toxic Effects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Surgery
Microplastics
Nanoplastics
Cardiovascular Diseases
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac surgery patients

Brief summary: The exponential growth in plastic production/use translates into a parallel increase in environmental plastic waste, which is constantly degraded into microplastics and nanoplastics. Information on the effects of microplastics on human health is still preliminary.

Cardiac surgery patients is a population high exposed to plastics. This observational study will obtain biological samples of cardiac surgery patients as a reference and vulnerable group of individuals highly exposed to microplastics and potentially more susceptible.

The objective of this research is to be able to detect microplastics on blood and operation samples of cardiac surgery patients as well as their potential genotoxic and immunological damage.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Elective cardiac surgery

Exclusion Criteria:

* Emergency surgery or limited-term surgery
* Previous cardiac surgery
* Previous severe liver disease
* Pregnant or planning to become pregnant
* Have a malignant tumor

Primary outcomes:
measure: Detection of microplastics in human heart tissue and the blood
timeFrame: perioperative: preoperative and pro-/postoperative blood and intraoperative heart tissue
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Anzhen Hospital
name: Kun Hua
role: STUDY_CHAIR
References:
Clinical trial NCT03659110: Post-Approval Safety Monitoring Program to Assess the Safety Profile of GARDASIL in China Usual Practice
Official title: Post-Approval Safety Monitoring Program to Assess the Safety Profile of GARDASIL in China Usual Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Keywords: vaccine
safety
Lead sponsor: Beijing Chaoyang District Centre for Disease Control and Prevention
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Volunteers aged 20-45 years

Brief summary: This is a post-Approval Safety Monitoring Program to assess the safety profile of GARDASIL in china usual practice.


Eligibility criteria: Inclusion Criteria:

* Any person who is intended to be inoculated with first dose GARDASIL based on his/her own wishes at screening

Exclusion Criteria:

1. Unable to provide written informed consent
2. Any woman who is known being pregnant at screening
3. Subject who is participating or going to participate in another study which involves GARDASIL administration

Primary outcomes:
measure: Evaluate the Rate of Adverse reactions of GARDASIL in China usual practice
timeFrame: 24 months
measure: Number of participants with adverse events following any dose of vaccine
timeFrame: within 30 days after each dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT07023510: The VALVE-AI Trial
Official title: VALidation of Screening Valvular Heart Disease Using Electrocardiogram Powered by Artificial Intelligence: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Valvular Heart Disease Patients
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 8648
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The goal of this clinical trial is to learn if an artificial intelligence-powered electrocardiogram (AI-ECG) can help detect moderate or severe valvular heart diseases (VHDs) in adults. The main question it aims to answer is:

．Can AI-ECG screening identify patients with significant heart valve diseases who may benefit from early echocardiography? Researchers will compare the rate of moderate or severe VHD detection between the experimental group and the control group to see if AI-ECG improve the detection rate of significant VHDs.

Participants will:

* Be classified as high- or low-risk for VHD using an AI-ECG system
* In the experimental group, high-risk participants will receive echocardiography based on AI-ECG results
* In the control group, usual clinical care will be provided without routine echocardiography for AI-ECG high-risk results.


Eligibility criteria: Inclusion Criteria:

* At least one 12-lead ECG within 1 year
* Age 60-85 years of age

Exclusion Criteria:

* Documented echocardiography within 3 years before indexed ECG
* Any known valvular heart disease
* History of any valvular surgery
* Post-heart transplant

Primary outcomes:
measure: Composite of any moderate or severe VHD
timeFrame: Within 90 days after randomization.
Secondary outcomes:
measure: Detection of moderate or severe MR
timeFrame: Within 90 days after randomization.
measure: Detection of moderate or severe AR
timeFrame: Within 90 days after randomization.
measure: Detection of moderate or severe AS
timeFrame: Within 90 days after randomization.
measure: Detection of moderate or severe TR
timeFrame: Within 90 days after randomization.
measure: New detection of other cardiac diseases
timeFrame: Within 90 days after randomization.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
Study officials:
References:
citation: Lin YT, Lin CS, Tsai CS, Tsai DJ, Lou YS, Fang WH, Lee YT, Lin C. Comprehensive clinical application analysis of artificial intelligence-enabled electrocardiograms for screening multiple valvular heart diseases. Aging (Albany NY). 2024 May 16;16(10):8717-8731. doi: 10.18632/aging.205835. Epub 2024 May 16.
Clinical trial NCT06140810: Impact of Atelectasis on RVEDP Following Orthotropic Heart Transplantation
Official title: Impact of Atelectasis and Lung Recruitment on RVEDP Measurement in Children Undergoing Cardiac Catheterization for Surveillance Following Orthotropic Heart Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Transplant Failure
Anesthesia
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2023-11-20
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a study in patients following orthotropic heart transplantation meeting the inclusion exclusion criteria.

Brief summary: Following orthoptopic heart transplantation (OHT), children undergo surveillance cardiac catheterizations to assess for signs of rejection including muscle biopsy as well as pressure measurements to guide post transplant treatment regiments. These procedures are done under general anesthesia which promotes lung tissue collapse (atelectasis). What is not known is the effect of atelectasis on intracardiac pressures which are a critical area of monitoring post-transplant patients for rejection.

Detailed description: Following orthoptopic heart transplantation (OHT), children undergo surveillance cardiac catheterizations to assess for signs of rejection including muscle biopsy as well as pressure measurements. These procedures are done under general anesthesia which promotes lung tissue collapse (atelectasis). Atalectaisis is known to alter intra-thoracic pressures and cardiac loading conditions. What is not known is the effect of atelectasis on intracardiac pressures which are a critical area of monitoring post-transplant patients for rejection. Therefore, the aim of this study is to identify if atelectasis impacts the pressure measurements obtained during cardiac catheterization.

Eligibility criteria: Inclusion Criteria:

* Patients having undergone orthotropic heart transplantation
* Patients requiring routine heart catheterization for post-transplant surveillance
* General anesthesia

Exclusion Criteria:

* Patient/parental refusal
* Patients with suspected or known acute rejection
* Known anti-rejection medication non-compliance
* Patients within 1 year following heart transplant
* Home oxygen requirement
* Previous lung surgery (e.g., lobectomy) other than biopsy
* Lung transplantation
* Known pulmonary fibrosis
* Known pulmonary hypertension (\>1/2 systemic)
* Sedation without the use of an airway device
* Active respiratory infection -Inability to provide recruitment breaths \>25mmHg -Cardiomegaly
* Recipient/donor size mismatch

Primary outcomes:
measure: Number of participants with reduction of right ventricular end diastolic pressure of 3mmHg or greater
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Childrens Hospital
state: Texas
Study officials:
affiliation: Texas Childrens Hospital
name: adam adker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01143610: A New Therapeutic Approach for Root Coverage
Official title: A New Regenerative Therapeutic Approach for Root Coverage: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Recession
Keywords: Root coverage
Graft
Soft tissue
Periodontal regeneration
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2010-06-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Different surgical techniques have been proposed for root coverage, showing varying results especially in areas of deep recessions. The aim of this study is to evaluate the effectiveness of the newly forming bone technique (NFB)as an alternative treatment for Miller class I or II deep recessions, requiring regeneration of lost periodontal tissues. Sample should be comprised of patients aged 18-45 years, both genders, presenting at least one site with marginal tissue recession \>4mm. Patients will be randomly assigned to either one of the groups, based on treatment technique: newly forming bone (NFB) or subepithelial connective tissue graft (SCTG). Clinical examinations will be performed by a single blinded examiner at baseline, 1, 3, 6 and 9 months after surgery. Intra-group analysis will be performed by one way analysis of variance for repeated measures. Inter-group analysis will be performed by unpaired t-test for each of evaluation periods.

Detailed description: Both gender patients presenting Miller class I or II recession defects \>4mm were selected. Patients were randomly assigned to treatment groups: newly forming bone graft (NFBG) or subepithelial connective tissue graft (SCT). Patients were treated in the period of February 2008 and March 2008 and monitored during 9 months.

Eligibility criteria: Inclusion Criteria:

* Healthy adults with at least one tooth presenting marginal tissue recession equal to or greater than 4mm in depth and one edentulous area or tooth to be extracted.

Exclusion Criteria:

* Smokers
* Pregnants
* Use of anti-convulsants, anti-hypertensives, cyclosporine or hormones
* Use of antibiotics for the last 6 months
* Patients under treatment for medical conditions or presenting systemic disorders that would impair treatment results (e.g.: uncontrolled diabetes mellitus)

Primary outcomes:
measure: Percentage of Root Coverage
timeFrame: Baseline, 9 months post-operatively
Secondary outcomes:
measure: Gain of Clinical Attachment Level
timeFrame: 9 months post-operatively
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: School of Dentistry at Bauru-USP, Discipline of Periodontics
state: SP
Study officials:
affiliation: School of Dentistry at Bauru, University of São Paulo
name: Adriana P Sant'Ana, DDS PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Dentistry at Bauru, University of São Paulo
name: Bruna R Ferraz, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02766010: A Comparative Clinical Study to Assess the Accuracy of TensorTip MTX, a Non Invasive Device
Official title: A Comparative Clinical Study to Assess the Accuracy of TensorTip MTX, a Non Invasive Device for the Measurement of Physiological and Hematological Parameters
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Blood Pressure
Lead sponsor: Cnoga Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2016-05-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 1. Aim- This study is aimed to access the accuracy of TensorTip MTX device measuring Hemoglobin A1C, Oxygen Concentration and Saturation ,Carbon Dioxide, Blood pH, Hemoglobin, Hematocrit, Red Cells Count, platelets, Blood Urea Nitrogen, Sodium, Potassium, Chloride, total bilirubin, cholesterol (HDL, LDL), Serum Creatinine, Peripheral Pulse Rate, Blood Pressure, Mean Arterial Pressure, cardiac output, cardiac index, stoke volume and blood gases compared with the simultaneous results from hospital references device (when available)
2. Hypothesis- Human physiological biomarkers may be measured from the color distribution of the internal or external (skin) tissue. The technology of the TensorTip device is based on the color distribution of the peripheral blood tissue, which enables the measurement of certain biomarkers and vital signs under consideration

Detailed description: 1. This is a comparative clinical trial in which the measurements obtained by the TensorTip device will be compared with those obtained by the reference devices used by the hospital on daily or periodic monitoring (the devices will be identified by name and version at the final report).
2. Eligible real time color signal obtained by the TensorTip during the measurement shall be recorded simultaneously with the measurements obtained by the reference devices (as described in the above point).

Eligibility criteria: Inclusion Criteria:

1. Male or female, age \> 18
2. Agree to sign voluntary inform consent.

Exclusion Criteria:

1. Refusal to sign an informed consent and to participate in the study.
2. Below the age of 18.
3. Finger size not suitable for the measurement chamber.
4. Injured skin in the measurement site.
5. Long fingernails

Primary outcomes:
measure: blood pressure measurement of the TensorTip against hospital readings
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01726010: 22-G-Procore Needle for the Diagnosis of SETs of the Upper GI Tract
Official title: Endoscopic Ultrasound Guided Biopsy of Subepithelial Tumors of the Upper Gastrointestinal Tract Using the 22-G-Procore Needle
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Subepithelial Tumors of the Upper Gastrointestinal Tract
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2012-11-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this prospective study is to evaluate the feasibility of the 22-G Core Biopsy Needle with reverse bevel (Procore TM) in biopsy sampling of subepithelial tumors of the upper gastrointestinal tract.


Eligibility criteria: Inclusion Criteria:

1. Patient age 18 years and older
2. All patients with subepithelial tumors of the upper GI tract (maximum size: 3 cm)

Exclusion Criteria:

1. Unable to obtain informed consent
2. ASA class 4 or 5
3. known pregnancy
4. contraindication endoscopy
5. contraindication for taking biopsies

Primary outcomes:
measure: diagnostic yield
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinikum rechts der Isar
state: Bavaria
Study officials:
References:
Clinical trial NCT03683810: The Effectiveness of Lactoferrin in the Management of Treatment-induced Anemia
Official title: The Effectiveness of Lactoferrin in the Management of Treatment-induced Anemia in Hematological Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Anemia
Keywords: hemoglobin
quality of life
Lead sponsor: Cyprus University of Technology
Sponsor class: OTHER
Collaborators: name: Hematological Clinic - Nicosia General Hospital
name: German Oncology Center, Cyprus
name: Limassol Hematology-oncology Center
First posted: 2018-09-25
Enrollment: 50
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: This will be a randomised control trial designed to test the effectiveness of lactoferrin in the management of treatment-induced anemia in patients with hematological malignancies.

Detailed description: Chemotherapy induced anemia (CIA) is a common adverse event in cancer patients reported to occur in 20-60% whilst the resulting low hemoglobin level is associated with impaired quality of life. Lactoferrin (LF) is a non-haem iron-binding protein that is part of the transferrin protein family, along with serum transferrin, ovotransferrin, melanotransferrin and the inhibitor of carbonic anhydrase, whose function is to transport iron in blood serum.

The aim of the study is to test the effectiveness of LF along with standard care in the management of treatment-induced anemia.

Eligibility criteria: Inclusion Criteria:

* Patients on active treatment (chemotherapy i.e. cyclophosphamide, doxorubicin, rituximab, cisplatin carboplatin, etoposide)
* Ability to independently complete the questionnaires

Exclusion Criteria:

* Allergy to Milk
* Lactose intolerance
* Celiac disease
* Patient of whom chemotherapy has been interrupted for more than 2 weeks (due to adverse effects)

Primary outcomes:
measure: Hemoglobin
timeFrame: Change from baseline at 2, 4, 6, 8, 10, 12
Secondary outcomes:
measure: Ferritin
timeFrame: Change from baseline at 2, 4, 6, 8, 10, 12
measure: Cytokine
timeFrame: Change from baseline at 2, 4, 6, 8, 10, 12 weeks
measure: LgG
timeFrame: Change from baseline at 2, 4, 6, 8, 10, 12 weeks
measure: LgA
timeFrame: Change from baseline at 2, 4, 6, 8, 10, 12 weeks
measure: LgM
timeFrame: Change from baseline at 2, 4, 6, 8, 10, 12 weeks
measure: General Quality of LIfe
timeFrame: Change from baseline at 4, 8, 12 weeks
measure: Health related quality of life
timeFrame: Change from baseline at 4, 8, 12 weeks
measure: Functional Assessment of Cancer Therapy Anemia
timeFrame: Change from baseline at 4, 8, 12 weeks
Other outcomes:
Locations:
city: Limassol
country: Cyprus
facility: Hematology-Oncology Center
city: Nicosia
country: Cyprus
facility: Nicosia General Hospital
Study officials:
affiliation: Cyprus University of Technology (Nursing Department)
name: Andreas CHARALAMBOUS
role: PRINCIPAL_INVESTIGATOR
References: