louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06472674: China Healthy Aging Cohort Study
Official title: China Healthy Aging Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Age Problem
Disability
Dementia
Death
Keywords: Disability, Dementia, Ageing, Cohort
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 6780
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community residents aged 60 years or older in China

Brief summary: This is a community-based prospective cohort study in China. The study has been initialized in 2024 and included older residents. The goal of this observational study is to explore the risk factors related to disability and dementia in the elderly Chinese community population, and develop a risk prediction model for disability and dementia.

Detailed description: This is a community-based prospective cohort study in China. Individuals who were aged 60 years or older, had lived in the communities for more than 1 year, and had signed the informed consent form were enrolled in the present study. The study has been initiated in 2024 and aimed to explore the risk factors related to disability and dementia in the elderly Chinese population, and develop a risk prediction model for disability and dementia. This work consists of three steps as follows. First, by integrating the data of the elderly cohort of 4 communities in Beijing, Shenzhen, Haikou and Hangzhou, we plan to establish a Chinese elderly database. Second, to explore the risk factors of disability and dementia in elderly Chinese. Third, to construct risk prediction models of disability and dementia in Chinese elderly.

Eligibility criteria: Inclusion Criteria:

* Aged 60 years or older
* Lived in the community for more than 1 year
* Signed the informed consent form

Exclusion Criteria:

* Cannot complete the survey

Primary outcomes:
measure: The prevalence and incidence of functional disability using a population-based survey
timeFrame: An average of 1 to 2 years
measure: The prevalence and incidence of mild cognitive impairment using a population-based survey
timeFrame: An average of 1 to 2 years
measure: The prevalence and incidence of dementia using a population-based survey
timeFrame: An average of 1 to 2 years
measure: The conversion rate of normal to mild cognitive impairment
timeFrame: An average of 1 to 2 years
measure: The conversion rate of mild cognitive impairment to dementia
timeFrame: An average of 1 to 2 years
measure: The prevalence and incidence of movement disorder using a population-based survey
timeFrame: An average of 1 to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Yi Tang, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04665674: Adult Pulmonary Langerhans Cell Histiocytosis: a National Registry-based Prospective Cohort Study
Official title: Enquête épidémiologique Sur la prévalence et le Pronostic de l'Histiocytose Langerhansienne Pulmonaire de l'Adulte en France
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Histiocytosis
Histiocytosis, Langerhans-Cell
Histiocytosis Pulmonary
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 500
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: All patients with newly diagnosed PLCH at adulthood (i.e. 18 years of age or older) referred to the French national reference centre for Histiocytoses

Brief summary: The long-term outcomes of adult patients with pulmonary Langerhans cell histiocytosis (PLCH), particularly survival, is largely unknown. This is the first prospective study in the field evaluating the long-term outcomes of PLCH patients. This french countrywide registry-based study included a large cohort of PLCH patients followed for a sufficiently long period to address risk factors of long-term outcomes of PLCH patients.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Diagnosis of PLCH was either histologically confirmed on a biopsy of an involved tissue, or based on the combination of the following criteria: 1) an appropriate clinical picture; 2) a typical nodulo-cystic pattern on lung high-resolution computed tomography (HRCT) and 3) exclusion of alternative diagnoses

Exclusion Criteria:

-

Primary outcomes:
measure: Overall survival
timeFrame: 20 years
Secondary outcomes:
measure: CRF
timeFrame: 20 years
measure: PH
timeFrame: 20 years
measure: Malignant diseases
timeFrame: 20 years
measure: Extra-pulmonary involvement in isolated PLCH
timeFrame: 20 years
measure: Annual prevalence
timeFrame: 20 years
Other outcomes:
Locations:
city: Paris
country: France
facility: French national reference centre for Histiocytoses
Study officials:
References:
citation: Benattia A, Bugnet E, Walter-Petrich A, de Margerie-Mellon C, Meignin V, Seguin-Givelet A, Lorillon G, Chevret S, Tazi A. Long-term outcomes of adult pulmonary Langerhans cell histiocytosis: a prospective cohort. Eur Respir J. 2022 May 26;59(5):2101017. doi: 10.1183/13993003.01017-2021. Print 2022 May.
Clinical trial NCT00709774: Right Ventricular Septal Pacing for the Prevention of Left Ventricular Dysfunction in Patients With Atrio-Ventricular Block
Official title: Right Ventricular Septal Pacing for the Prevention of Left Ventricular Dysfunction in Patients With Atrio-Ventricular Block
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrio-Ventricular Block
Lead sponsor: Osaka General Medical Center
Sponsor class: OTHER
First posted: 2008-07-03
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of the right ventricular septal pacing on left ventricular function compared with right ventricular apical pacing.


Eligibility criteria: Inclusion Criteria:

* the patients who need pacemaker implantation for atrio-ventricular block

Exclusion Criteria:

* Pregnancy, left ventricular dysfunction at the time of implantation

Primary outcomes:
measure: Hospitalization for the heart failure
timeFrame: 6 months
Secondary outcomes:
measure: incidence of atrial fibrillation
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05231174: Efficacy of Using Large Language Model to Assist in Diabetic Retinopathy Detection
Official title: Efficacy of Using Large Language Model to Assist in Diabetic Retinopathy Detection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diagnosis
Diabetic Retinopathy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 535
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: With the increase in population and the rising prevalence of various diseases, the workload of disease diagnosis has sharply increased. The accessibility of healthcare services and long waiting times have become common issues in the public health medical system, with many primary patients having to wait for extended periods to receive medical services. There is an urgent need for rapid, accurate, and low-cost diagnostic services.


Eligibility criteria: Inclusion Criteria The study will include adults aged 18 years and above who have been diagnosed with Type 2 diabetes but have not previously been screened for DR. Participants must demonstrate good compliance with clinical examinations, and provide informed consent.

Exclusion criteria The study will exclude patients who have previously been diagnosed with DR, those who have recently undergone eye surgery, and those with other significant eye diseases that could potentially confound the results of DR screening. Individuals with ocular, auditory, or cognitive impairments that prevent the use of mobile phones or reading will also be excluded.

Primary outcomes:
measure: AUROC of the self-evaluation tool
timeFrame: Immediately after using the chatbot
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhognshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yingfeng Zheng
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00660374: Safety and Efficacy of Insulin NPH Compared to a New Insulin Formulation in Subjects With Type 2 Diabetes
Official title: Assessment of Safety and Efficacy of Insulin NPH Compared to a New Insulin Formulation on Glycaemic Control in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-04-17
Enrollment: 402
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 trial is conducted in South America. This trial aims for a comparison of the safety and efficacy of insulin NPH and a new insulin formulation on blood glucose control.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes for at least 12 months
* Current NPH treatment for at least 3 months - alone or as the only insulin in combination with OADs
* Body Mass Index (BMI) less than or equal to 40 kg/m2
* HbA1c less than or equal to 9.5%
* FPG less than or equal to 12 mmol/L

Exclusion Criteria:

* Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
* Treatment with more than 1 IU/kg NPH insulin daily
* Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
* Known or suspected allergy to trial products or related products
* Receipt of any investigational drug within one month prior to this trial
* Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers

Primary outcomes:
measure: HbA1c
timeFrame: For the duration of the trial
Secondary outcomes:
measure: Fructosamine
timeFrame: For the duration of the trial
measure: FPG
timeFrame: For the duration of the trial
measure: 4-point SMPG profiles
timeFrame: For the duration of the trial
measure: Incidence of hypoglycaemic episodes
timeFrame: For the duration of the trial
measure: Frequency and severity of adverse events (including injection site reactions)
timeFrame: For the duration of the trial
measure: Laboratory safety parameters (haematology, biochemistry and lipids)
timeFrame: For the duration of the trial
measure: Physical examination and vital signs
timeFrame: For the duration of the trial
measure: HbA1c
timeFrame: For the duration of the trial
Other outcomes:
Locations:
city: Salvador
country: Brazil
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03854565: Glycocalyx Biomarkers in ARDS for Clinical Prognosis and Pulmonary Fibrosis
Official title: Predictive Value of Glycocalyx Biomarkers in Mechanical Ventilation of Patients With ARDS for Clinical Prognosis and Long-term Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS, Human
Endothelial Dysfunction
Mechanical Ventilation Pressure High
Keywords: ARDS
Endothelial Dysfunction
mechanical ventilation
Glycocalyx
pulmonary fibrosis
mortality
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients have been diagnosed ARDS with mechanical ventilation, and do not been used heparin, molecular heparin, chondroitin sulfuric acid.

Brief summary: ARDS is a severe disease in ICU, and could induce high mortality. Glycocalyx is an important matrix construction which covers endothelial cells, it could protect endothelial cells injury and the glycocalyx biomarkers could predict pulmonary injury.

Decorin is a member of the small leucine-rich proteoglycan (SLRP) family, contains a single glycosaminoglycan (GAG) chain and a core protein with 12 leucine-rich repeats. In the previous study, decorin is associated with cardiac and liver fibrosis, however, the effects of decorin on ARDS pulmonary fibrosis have not been clarified.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18yrs and \<80yrs
2. Meet ARDS Berlin definition
3. With mechanical ventilation

Exclusion Criteria:

1. have chronic pulmonary disease
2. have use heparin or low molecular heparin or chondroitin sulfuric acid

Primary outcomes:
measure: 28 days mortality from patients involved in the study
timeFrame: 28 days
Secondary outcomes:
measure: CT and syndecan-1 to evaluate pulmonary fibrosis
timeFrame: 1mon, 3mon and 6 month
measure: pulmonary function test to evaluate pulmonary function
timeFrame: 1mon, 3mon and 6 month
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital, Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda hospital, Southeast University, Jiangsu, China
name: Chun C Pan, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02312765: Reducing Heart Failure Re-admissions by Enhancing Sleep Apnea Treatment Adherence
Official title: Reducing Heart Failure Re-admissions by Enhancing Sleep Apnea Treatment Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Sleep Apnea Syndromes
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: AirCare Labs, LLC
First posted: 2014-12-09
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Sleep apnea, characterized by abnormal breathing at night, is often untreated in patients with heart failure. Helping patients to effectively use the most common form of treatment for sleep apnea, positive airway pressure therapy, can improve their heart function. This can reduce the likelihood that the patient will be re-admitted to the hospital. AirCareLabs has developed an innovative solution that allows patients to communicate with health care providers 24 hours a day, thus allowing them to get the help they need to effectively use positive airway pressure and thereby reduce the risk of being re-admitted to the hospital.


Eligibility criteria: Inclusion Criteria:

* Congestive heart failure and sleep apnea

Exclusion Criteria:

* Cognitive impairment

Primary outcomes:
measure: Number of Participants Adhering to Positive Airway Pressure (PAP)
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pennsylvania
name: Nalaka Gooneratne, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01002365: Perioperative Hyperoxygenation and Wound Site Infection Following Surgery for Acute Appendicitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Appendicitis
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2009-10-27
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Patients undergoing open appendectomy for acute appendicitis were enrolled in a randomized prospective study.


Eligibility criteria: Inclusion Criteria:

* Consent was given
* 15 years old or older
* Underwent acute appendicitis

Exclusion Criteria:

* Lack of follow up
* Younger than 15 years
* Not eligible according to physician decision

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Western Galilee Hospital
Study officials:
References:
citation: Bickel A, Gurevits M, Vamos R, Ivry S, Eitan A. Perioperative hyperoxygenation and wound site infection following surgery for acute appendicitis: a randomized, prospective, controlled trial. Arch Surg. 2011 Apr;146(4):464-70. doi: 10.1001/archsurg.2011.65.
Clinical trial NCT02138565: Effect of Bariatric Surgery on Kidney Function
Official title: Effect of Bariatric Surgery on Kidney Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese Subjects Who Will Undergo Gastric By-pass Surgery
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
First posted: 2014-05-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Primary hypothesis:

A large reduction in weight is not associated with a change in accurately measured glomerular filtration rate (GFR) (51Chromium ethylenediaminetetraacetic acid plasma clearance (51Cr-EDTA)).

Secondary hypothesis:

A large reduction in weight is associated with a greater change in estimated GFR (The Modification of Diet in Renal Disease (MDRD-formula)) than in accurately measured GFR.

Other formulas for estimated GFR (Cockcroft Gault, Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), CKD-EPI with cystatin C) are better correlated with accurately measured GFR.


Eligibility criteria: Inclusion Criteria:

* Male or female, older than 18 years of age
* Appointed to gastric by-pass surgery on Hvidovre Hospital, Denmark

Exclusion Criteria:

* Withdrawal of surgical indication
* Severe oedema or ascites

Primary outcomes:
measure: Change in accurately measured GFR
timeFrame: Up to 6 months and 18 months after surgery
Secondary outcomes:
measure: Change in estimated GFR (as measured by the MDRD formula, the Cockcroft Gault formula, CKD-EPI formula and CKD-EPI with cystatin C formula).
timeFrame: Up to 6 months and 18 months after surgery
measure: Change in 24hour blood pressure
timeFrame: Up to 6 months and 18 months after surgery
measure: Change in arterial stiffness (as measured by sphygmocor)
timeFrame: Up to 6 months and 18 months after surgery
measure: Change in body composition, as measured by Dual-energy X-ray absorptiometry scan (DXA-scan)
timeFrame: Up to 6 months and 18 months after surgery
measure: Change in accurately measured GFR compared with change in estimated GFR
timeFrame: Up to 6 months and 18 months after surgery
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Peter Rossing
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Peter Rossing, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: von Scholten BJ, Persson F, Svane MS, Hansen TW, Madsbad S, Rossing P. Effect of large weight reductions on measured and estimated kidney function. BMC Nephrol. 2017 Feb 6;18(1):52. doi: 10.1186/s12882-017-0474-0.
Clinical trial NCT03693365: Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
Official title: The Reliability of Noninvasive Effective Pulmonary Blood Flow to Detect Fluid Responsiveness During a Positive End-expirator Trial in Ventilated Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Keywords: Carbon dioxide
Pulmonary blood flow
Ventilation
Lead sponsor: Hospital Privado de Comunidad de Mar del Plata
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac and noncardiac surgery patients ASA 2-4

Brief summary: Fluid responsiveness is difficult to assess at the bedside. The accuracy of published techniques to detect preload-dependent patients have many pitfalls and limitations. The present study test the role of noninvasive effective pulmonary blood flow measured by expired carbon dioxide to detect fluid responsivess in mechanically ventilated patients.

Detailed description: This is a prospective and observational study designed to test the accuracy of the non-invasive effective pulmonary blood flow measured by the capnodynamic methodology for detect preload-dependent patients.

Fourty patients undergoing mechanical ventilation during surgery will be studied. Preload-depency (fluid responsiveness) will be tested during an increase in end-expiratory pressure (PEEP) from 5 to 10 cmH2O during one minute. Pulse pressure variation will be use as the reference method to detect preload-dependency. The effective pulmonary blood flow will be continuously recorded during the PEEP maneuver. Receiver Operator Curves will be used to detect fluid responsiveness taking a pulse pressure variation higher than 13%.The corresponding cut off value for the effective pulmonary blood flow signal will be determined..

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Programmed cardiac and noncardiac surgeries
* Need of invasive arterial blood pressure monitoring.

Exclusion Criteria:

* Emergency surgeries.
* Acute pulmonary diseases
* Arrhytmias
* Congestive cardiac failure

Primary outcomes:
measure: Fluid responsivess assessment with the effective pulmonary blood flow
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mar del Plata
country: Argentina
facility: Hospital Privado de Comunidad
state: Buenos Aires
Study officials:
affiliation: Hospital Privado de Comunidad de Mar del Plata
name: Gerardo Tusman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tusman G, Groisman I, Maidana GA, Scandurra A, Arca JM, Bohm SH, Suarez-Sipmann F. The Sensitivity and Specificity of Pulmonary Carbon Dioxide Elimination for Noninvasive Assessment of Fluid Responsiveness. Anesth Analg. 2016 May;122(5):1404-11. doi: 10.1213/ANE.0000000000001047.