louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06984510: Accelerated Biological Aging is Associated With Increased Risk of T2DM in the MASLD Population
Official title: Accelerated Biological Aging is Associated With Increased Risk of T2DM in the MASLD Population: a Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 2 Diabetes Mellitus (T2DM)
Metabolic Dysfunction-Associated Steatotic Liver Disease
Biological Age
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 2720
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective cohort study is based on physical examination at the Physical Examination Center of The First Affiliated Hospital of Ningbo University and included participants aged 20 to 90 years. Individuals included had available abdominal ultrasound data and at least one recorded metabolic indicator per year. Participants with type 2 diabetes at baseline or with other causes of hepatic steatosis were excluded. The study population was categorized into MASLD and non-MASLD groups for comparative analysis.

Brief summary: The association between biological aging and type 2 diabetes mellitus (T2DM) incidence in individuals with and without metabolic dysfunction-associated steatotic liver disease (MASLD) remains unclear.We assessed biological age by calculating phenotypic age (PhenoAge), Klemera-Doubal method (KDMAge), and homeostatic dysregulation (HDAge). To examine the association of biological ageing with the risk of T2DM, cox regression models were conducted. Furthermore, we applied survival analysis, restricted cubic spline models and population attributable fraction (PAF) to further evaluate the association between biological ageing and T2DM incidence.


Eligibility criteria: Inclusion Criteria:

1. Abdominal ultrasound data available in annual health check-up records
2. At least one of the following five metabolic indicators recorded annually:

(1) Body mass index (BMI) or waist circumference (2) Blood pressure (3) Serum triglycerides (4) High-density lipoprotein cholesterol (HDL-C) (5) Fasting plasma glucose or glycated hemoglobin (HbA1c)

Exclusion Criteria:

1. Age \<20 or \>90 years
2. Other causes of hepatic steatosis (e.g., alcoholic liver disease or hepatitis B infection)
3. Type 2 diabetes mellitus at baseline
4. Missing baseline data for any of the following variables: systolic blood pressure, albumin, alkaline phosphatase, blood urea nitrogen, creatinine, glycated hemoglobin (HbA1c), total cholesterol, lymphocyte percentage, white blood cell count, mean corpuscular volume, uric acid, fasting plasma glucose, and red cell distribution width (RDW)

Primary outcomes:
measure: Incidence of onset T2DM
timeFrame: through study completion, an average of 3 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ningbo
country: China
facility: the First Affiliated Hospital of Ningbo University Ningbo, Zhejiang, China, 315000
state: Zhejiang
Study officials:
References:
Clinical trial NCT02230410: Cryo Balloon for Residual Barrett's Esophagus
Official title: CryoBalloon Focal Ablation System for Residual Barretts Esophagus Post Ablation; a Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett's Esophagus
Keywords: Barrett's
high grade dysplasia
ablation
cyrotherapy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Pentax Medical
First posted: 2014-09-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being done to see if treating residual Barrett's Esophagus after previously having undergone Radiofrequency ablation or Endoscopic Mucosal resection can be eliminated with focal cryotherapy.


Eligibility criteria: Inclusion criteria:

* Age \> 18 years old
* Able to provide informed consent
* Patients with unifocal or multifocal BE with 2 cm who have failed at least 2 serial RFA or other endoscopic therapy such as Endoscopic Mucosal resection,

Exclusion criteria:

* Age younger than 18 years old
* Presence of esophageal varices
* Esophageal stricture precluding passage of an endoscope
* Inability to provide informed consent
* Esophageal cancer (T2 and above)
* Coagulopathy with INR \> 2.0, thrombocytopenia with platelet counts \< 50,000
* Pregnancy (if required a pregnancy test would be performed as part of routine clinical care)

Primary outcomes:
measure: Eradication of Barrett's Esophagus
timeFrame: 3 months post Cryoballon Focal Ablation
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kenneth Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04738110: Post-operative Imaging in High Grade Glioma: is Management Influenced?
Official title: Post-operative Imaging in High Grade Glioma: is Management Influenced?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glioma
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HGG (Grade III and IV WHO criteria) patients discussed in MDTM between March 2018 and March 2020 at KCH and NHNN are being studied.

Brief summary: Magnetic resonance imaging (MRI) is likely to play an important role in the management of high grade glioma. Appropriate and timely neuroimaging in the follow up period is believed to be crucial in making subsequent management decisions. However, there is a paucity in the literature providing evidence to support this. The aim of this study is to determine whether neuroimaging performed at each component of the patient pathway after initial high grade glioma treatment, actually results in a real change in management (as opposed to a perceived change in management). The main emphasis is on all imaging used at the time of a MDM, however, we will also study specifically dynamic susceptibility contrast-enhanced (DSC) MRI and dynamic contrast enhanced (DCE) MRI.

The study is in the format of Mock MDMs to be compatible with real life decision making. Using retrospective identical information available at the MDM i.e. compiled recent correspondence, histopathological and molecular information, the MDM members (oncology nurse, oncologist, neurosurgeon, neuroradiologist, pathologist/molecular scientist) will prospectively determine the patient management with and without the imaging.


Eligibility criteria: Inclusion Criteria:

* Histologically proven HGG patients (Grade III and IV WHO criteria)
* Underwent surgery, radiotherapy and chemotherapy regimen according to 2018 NICE guidelines (1)
* \>=18 years old
* Has follow-up MRI imaging (T1, T2, FLAIR and T1 with contrast enhancement) and also DSC and DCE imaging
* Evaluated at MDT meetings between March 2018 and March 2020.

Exclusion Criteria:

* Patients who have insufficient clinical and radiological follow-up

Primary outcomes:
measure: Determine how MR imaging influences the management of HGG patients
timeFrame: 12 months
Secondary outcomes:
measure: Determine how advanced MR imaging influences the management of HGG patients
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King´s College Hospital NHS Foundation trust
Study officials:
References:
Clinical trial NCT02158910: A Plan on Investigation and Collection of Aricept Safety Information With a Dose Increase on Alzheimer's Disease Patients
Official title: A Plan on Investigation and Collection of Aricept Safety Information With a Dose Increase on Alzheimer's Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-09
Enrollment: 2231
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Alzheimer's disease

Brief summary: The purpose of the study is for investigation and collection of Aricept safety information with a dose increase on Alzheimer's disease patients.

Detailed description: This is an observational study to systematically investigate domestic patients with Alzheimer's disease to figure out the safety under a situation of the use of Donepezil HCl 23mg. Additionally, if the dose of Donepezil HCl increase, there is need to examine the safety of Donepezil HCl 23mg in depth for patients with Alzheimer's disease by comparing aspects of occurring adverse events by the type of Donepezil HCl increase.

Eligibility criteria: Inclusion Criteria

1. Patients who admitted the reading and using of his/her biographical and medical data by word
2. Patients who maintained Aricept dosage for at least 3 months before involved in the study

Exclusion Criteria

1. Hypersensitivity to the active substance or to any of the excipients
2. Breast feeding
3. Pregnancy

Primary outcomes:
measure: Safety and tolerability due to an increase of Aricept in patients with Alzheimer's disease.
timeFrame: Up to 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
city: Chungcheongbuk-do
country: Korea, Republic of
city: Chungcheongnam-do
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Gangwon-do
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Gyeonggji-do
country: Korea, Republic of
city: Gyeongsangbuk-do
country: Korea, Republic of
city: Gyeongsangnam-do
country: Korea, Republic of
city: Jeju-do
country: Korea, Republic of
city: Jeollabuk-do
country: Korea, Republic of
city: Jeollanam-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
References:
Clinical trial NCT04367610: Effects of A Standardized Treatment Approach on Kidney Transplant Recipients With Antibody-Mediated Rejection
Official title: Effects of A Standardized Treatment Approach Comprising Plasma Exchange, Intravenous Immunoglobulin and Rituximab on Kidney Transplant Recipients With Acute or Chronic Antibody-Mediated Rejection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Antibody-mediated Rejection
Kidney Transplant Rejection
Graft Loss
Keywords: antibody-mediated rejection
kidney transplantation
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 75
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: Kidney transplant recipients with biopsy-proven acute or chronic antibody-mediated rejection who were treated using 6 sessions of therapeutic plasma exchange, 2 g/kg of intravenous immunoglobulin and 1-2 weekly doses of 375 mg/m2 rituximab.

Brief summary: Antibody-mediated rejection (ABMR) is one of the leading causes of graft loss in kidney transplant recipients (KTRs). Although it is a well characterized entity, there is limited data regarding effective treatment options for preserving graft functions. Moreover, results from different studies have been contradictory. Therefore, we conducted a study using our registry data to evaluate the effects of a standardized treatment approach consisting of therapeutic plasma exchange (regular plasmapheresis, double filtration plasmapheresis or immunoadsorption), intravenous immunoglobulin and rituximab on KTRs with acute or chronic ABMR.


Eligibility criteria: Inclusion Criteria:

* Being a kidney transplant recipient with biopsy-proven acute or chronic antibody-mediated rejection who were treated using 6 sessions of therapeutic plasma exchange, 2 g/kg of intravenous immunoglobulin and 1-2 weekly doses of 375 mg/m2 rituximab.

Exclusion Criteria:

* Not providing or withdrawing consent.

Primary outcomes:
measure: Graft Loss
timeFrame: 2-5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: Department of Internal Medicine, Istanbul Faculty of Medicine
name: Halil Yazici, MD
role: STUDY_CHAIR
affiliation: Department of Internal Medicine, Istanbul Faculty of Medicine
name: Safak Mirioglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Djamali A, Kaufman DB, Ellis TM, Zhong W, Matas A, Samaniego M. Diagnosis and management of antibody-mediated rejection: current status and novel approaches. Am J Transplant. 2014 Feb;14(2):255-71. doi: 10.1111/ajt.12589. Epub 2014 Jan 8.
Clinical trial NCT05941910: The Effect of Coenzyme Q10 on Endothelial, Vascular and Myocardial Function
Official title: The Effect of 6-month Treatment With Coenzyme Q10 on Endothelial, Vascular and Myocardial Function in Patients With Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: Non-alcoholic fatty liver disease
endothelial function
vascular function
myocardial function
coronary flow reserve
endothelial glycocalyx
flow mediated dilation
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-alcoholic fatty liver disease (NAFLD) is associated with increased cardiovascular risk. The aim of this study is to investigate the effects of coenzyme Q10 (CoQ10) on endothelial, vascular and myocardial function in patients with NAFLD

Detailed description: Non-alcoholic fatty liver disease (NAFLD) is associated with increased cardiovascular risk. The aim of this study is to investigate the effects of coenzyme Q10 (CoQ10) on endothelial, vascular and myocardial function in patients with NAFLD. In this trial patients with NAFLD will receive 240mg Q10 or placebo. At baseline and at 6 months, will be measured: a) Perfused boundary region (PBR) of the sublingual vessels using the SideviewDarkfieldimaging technique (Microscan, Glycocheck), b) pulse wave velocity (PWV-Complior, ALAM), c) flow-mediated dilation (FMD) of the brachial artery, d) left ventricular (LV) global longitudinal strain (GLS), and e) controlled attenuation parameter (CAP)for the quantification of liver steatosis by liver elastography (Fibroscan, Echosens).

Eligibility criteria: Inclusion Criteria:

* NAFLD AND one of below :

  1. dyslipidemia, as it is defined in the metabolic syndrome
  2. increased waist circumference as defined in the metabolic syndrome
  3. Arterial hypertension,
  4. overweight, (BMI\>25)
  5. polycystic ovary syndrome,

Exclusion Criteria:

* Chronic Kidney Disease
* Heart Failure
* Liver failure
* Pregnancy/ Breast feeding
* Active malignancy (receiving Chemotherapy/immunotherapy)

Primary outcomes:
measure: The effect of Q10 on Left Ventricular Myocardial Function
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Vaia Lambadiari
state: Attiki
Study officials:
References:
Clinical trial NCT06168110: A New Treatment Option for Mastalgia
Official title: Transcutaneous Electrical Nerve Stimulation is a Promising Novel Non-pharmacological Treatment Alternative for Mastalgia: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mastalgia
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to determine the effectiveness of transcutaneous electrical nerve stimulation (TENS) treatment on pain and quality of life in mastalgia, which treatment has not yet reached a consensus.

Detailed description: The main objective of this study is to determine the effectiveness of transcutaneous electrical nerve stimulation (TENS) treatment on pain and quality of life in mastalgia, which treatment has not yet reached a consensus. This randomized controlled clinical trial was completed with 20 women suffering from mastalgia. Patients were randomly assigned to the TENS treatment and sham application groups. Pain intensity, pain patterns and quality of life were evaluated with Breast Pain and SF-36 questionnaires before and 10 days after treatment in all patients.

Eligibility criteria: Inclusion Criteria:

* Patients with mastalgia between 18 and 70 yrs old

Exclusion Criteria:

* Previous or new diagnosis of diseases that may cause extramammary mastalgia (history of previous breast surgery; inflammatory and/or tumoral breast or chest disorders such as mastitis, fibrocystic breasts, breast cancer or chest malignancies etc.)
* Having with conditions that might prevent TENS application (pacemaker, metal prosthesis, epilepsy, etc.)
* Being unable or insufficient to fill the questionnaires.

Primary outcomes:
measure: Pain intensity
timeFrame: Before and 10 days after treatment
Secondary outcomes:
measure: Quality of life
timeFrame: Before and 10 days after treatment
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Universityt School of Medicine
Study officials:
affiliation: Ankara University
name: Aysun Genç, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06926010: Hemodynamic Monitoring Carotid Surgery
Official title: Effect of a Predictive Hemodynamic Approach on the Stump Pressure During Carotid Endoartectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carotid Artery Diseases
Haemodynamic Monitoring
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 120
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: patients scheduled for carotid endoarterectomy will be randomly assigned to a group in which arterial hypotension will be avoided by a predictive haemodynamic approach or to a group in which arterial hypotension will be treated in a standard manner


Eligibility criteria: Inclusion Criteria:

- \>18 years old patients

Exclusion Criteria:

* Body MassIndex \> 35 Kg /m2;
* Atrial Fibrillation
* Urgent surgery
* Pregnancy

Primary outcomes:
measure: stump pressure
timeFrame: during surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Policlinico Gemelli
Study officials:
References:
Clinical trial NCT03283410: Determination of Propofol Target Concentration for Young and Elderly by Suppression Rate Analysis
Official title: Determination of Propofol Target Concentration for Young and Elderly by Suppression Rate Analysis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Anesthesia
Keywords: propofol
dose-response
elderly
young adults
Lead sponsor: Brasilia University Hospital
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Propofol's dose-response curve is know for the average adult but propofol's plasmatic concentration under total intravenous anesthesia differences between young and elderly must be modeled. Adaptative clinical trial (Dixon's Up and Down) for determination of ED95% of propofol concentration for hypnosis under general anesthesia for young and elderly adults.

Detailed description: Propofol's dose-response curve is know for the average adult but propofol's plasmatic concentration under total intravenous anesthesia differences between young and elderly must be modeled. Method: adaptative clinical trial (Dixon's Up and Down method) for determination of ED95% of propofol concentration (plasmatic, Marsh model) for hypnosis (BIS ranging from 40 to 60) under general anesthesia for young and elderly adults.

Eligibility criteria: Inclusion Criteria:

* Both sex
* Between 18-28 or 65-75 years old
* ASA physical status I or II
* no pre-anesthetic medications prescribed
* scheduled for surgery under general anesthesia
* willing to participate and sign informed consent.

Exclusion Criteria:

* Contraindications for propofol usage
* history of neurologic or psychiatric diseases
* drug abusers
* users of drugs that alter central nervous system
* pregnancy
* emergency surgeries
* rapid sequence intubation.

Primary outcomes:
measure: BIS value greater than 60 or lower than 40 during general anesthesia
timeFrame: BIS value greater than 60 or lower than 40 during general anesthesia
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor
name: Gabriel MN Guimaraes, MsC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00688610: Antibiotics in Patients With Acute Respiratory Tract Infection With Procalcitonin as Parameter
Official title: Antibiotics in Patients With Acute Respiratory Tract Infections in Primary Care in Consideration of Procalcitonin as Additive Parameter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Tract Infection
Keywords: primary care
procalcitonin
antibiotic prescription
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2008-06-03
Enrollment: 571
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Antibiotics in patients with acute respiratory tract infections in primary care in consideration of procalcitonin as additive parameter.

The purpose of this study is to compare the ordinary manner of antibiotic- prescription with the prescription in consideration of procalcitonin-value in patients with acute respiratory tract infections.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Informed consent
* Respiratory tract infection based on the clinical judgement of the primary care physician

Exclusion Criteria:

* Antibiotic pretreatment in previous 14 days
* Portal hypertension
* Major surgeries or multiple trauma which require hospitalization, in previous 4 weeks
* Autoimmune disease and systemic diseases (lupus erythematodes, wegener´s disease)
* Peritoneal dialysis
* Acute treated or recently operated medullary c-cell-carcinoma, SCLC, carcinoid
* Other inflammatory diseases (e.g. urinary tract infection, pyelonephritis, pancreatitis

Primary outcomes:
measure: days with significant impairment due to acute respiratory tract infection
timeFrame: 14 to 28 days after infection
Secondary outcomes:
measure: number of antibiotic prescriptions
timeFrame: 28 days
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medical School Hannover, Department Pneumology
Study officials:
affiliation: Medical School Hannover
name: Olaf Burkhardt, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burkhardt O, Ewig S, Haagen U, Giersdorf S, Hartmann O, Wegscheider K, Hummers-Pradier E, Welte T. Procalcitonin guidance and reduction of antibiotic use in acute respiratory tract infection. Eur Respir J. 2010 Sep;36(3):601-7. doi: 10.1183/09031936.00163309. Epub 2010 Feb 25.