louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01071772: The Effect of Hyperglycemia on LV Function and Exercise Capacity in Diabetics With and Without Heart Failure.
Official title: Metabolic Substrate Modulation in Insulin Treated Diabetics With and Without Heart Failure: The Effect of Hyperglycemia on Left Ventricular Function and Exercise Capacity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Type 2 Diabetes
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Danish Heart Foundation
name: Region midtjyllands sundhedsvidenskabelige forskningsfond
First posted: 2010-02-19
Enrollment: 18
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Diabetes and Heart Failure are diseases with high morbidity and increased risk of death. Former investigations has shown that diabetes worsens the prognosis of heart failure. However it is uncertain how short term diabetic dysregulation in type 2 diabetics affect cardiac function.

Our hypothesis is that short term dysregulation affects left ventricular function and exercise capacity in insulin treated type 2 diabetics with and without heart failure.

To elucidate this hypothesis diabetic patients with and without heart failure will be investigated after overnight state of either high or normal blood glucose levels on two separate occasions. Metabolic and hormonal parameters will be measured. Systolic and diastolic cardiac function will be assessed, exercise capacity and post exercise regional myocardial tissue velocity as well as 6 minutes walk test will be investigated on both occasions. The study will be a randomized cross-over design.


Eligibility criteria: Inclusion Criteria:

* Either normal ejection fraction (EF) or heart failure (EF =\<45%)
* Insulin treated type 2

Exclusion Criteria:

* Forme stroke with significant physically or mentally disabilitating disorders
* advanced renal disease (creatinine levels \>220 mM)
* advanced lever disease (alanine aminotransferase \> 3 times over reference level).
* pregnancy
* other significant disabilitating disorders

Primary outcomes:
measure: 1: Cardiac systolic (EF by 2D and 3D echocardiography) and diastolic (e´/E and E/A) function before and after exercise.
timeFrame: 1-4 weeks
measure: Exercise capacity
timeFrame: 1-4 months
Secondary outcomes:
measure: Regional left ventricular function before and after maximum exercise(regional 2D tissue velocity and strain)
timeFrame: 1-4 weeks
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department ofCardiology, Aarhus University Hospital, Skejby
state: Region Midtjylland
Study officials:
affiliation: Dept. of cardiolgy, Aarhus University hospital, Skejby. Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark
name: Hans Erik Boedker, Prof, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05667272: A Study on the Occurrence Time of Grade-B Pancreatic Fistula After Pancreatoduodenectomy
Official title: A Study on the Occurrence Time of Clinically Relevant Postoperative Pancreatic Fistula of Grade-B After Pancreatoduodenectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Pancreatic Fistula
Keywords: postoperative pancreatic fistula
Lead sponsor: Changzhou Second People's Hospital affiliated with Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 216
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: (1) Patients with PD or LPD surgery; (2) Surgery performed by the same surgical team.

Brief summary: To confirm the time point of CR-POPF of grade-B that patients with biochemical leak after PD or LPD turned into.

Detailed description: 1. To confirm the time point of CR-POPF of grade-B that patients with biochemical leak after PD or LPD turned into.
2. Establishment of risk assessment model for Grade B fistula.

Eligibility criteria: Inclusion Criteria:

* Patients underwent Pancreatoduodenectomy (PD) or Laparoscopic pancreatoduodenectomy (LPD) surgery.
* Surgery performed by the same surgical team.

Exclusion Criteria:

* PD or LPD combined with another organ resection.
* PD or LPD performed due to trauma.
* PD or LPD for emergency treatment, such as the rupture and bleeding of tumor.
* Palliative resection.
* Patients with severe organ dysfunction before surgery.
* Patients treated with preoperative neoadjuvant chemotherapy or other treatments (Radiotherapy, targeted immunotherapy, etc.).
* Patients with missing data for clinical or radiographic variables.

Primary outcomes:
measure: Postoperative complications
timeFrame: up to postoperative 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Changzhou
country: China
facility: Changzhou Second People's Hospital affiliated to Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Changzhou Second People's Hospital
name: chunfu zhu, PhD
role: STUDY_CHAIR
References:
citation: Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CM, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.
Clinical trial NCT03741972: Metabolic and Hemodynamic Effects of the Inhibitors of Type 2 Sodium Glucose Co-transporters (ISGLT2) in Diabetic Patients With Heart Failure
Official title: Metabolic and Hemodynamic Effects of the Inhibitors of Type 2 Sodium Glucose Co-transporters (ISGLT2) in Diabetic Patients With Heart Failure. GLUCOSUR-IC Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart failure
Diabetes
iSGLT2
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with type 2 diabetes and heart failure who attend a university hospital heart failure unit.

Brief summary: Inhibitors of the type 2 sodium-glucose co-transporter (iSGLT2) may improve the metabolic and hemodynamic profile in patients with DM2 and heart failure.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes
* HbA1c\> 6.5%
* Estimated GF\> 45 ml / min
* BMI: ≥25 Kg / m2
* Stable pharmacological treatment of Heart Failure in the last 3 months

Exclusion Criteria:

* Diabetes type 1 or type LADA (presence of antibodies against GAD and/or IA-2 positive)
* DM2 with C-peptide \<1 ng / mL
* GEF \<45 ml / min
* Recurrent urinary tract infections

Primary outcomes:
measure: Change in cardiac biomarkers
timeFrame: 12 months
Secondary outcomes:
measure: Change in quality of life: EuroQol-5D questionnaire (EuroQol five dimension questionnaire)
timeFrame: 12 months
measure: Improvement of pulmonary congestion
timeFrame: 12 months
measure: Improve in the 6-minute walk
timeFrame: 12 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Germans Trias i Pujol University Hospital
Study officials:
affiliation: Germans Trias i Pujol Hospital
name: Nuria Alonso Pedrol
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03190772: The Role of Expectations in the Pharmacological Treatment of Depression - An Experimental Investigation
Official title: The Role of Expectations in the Pharmacological Treatment of Depression - An Experimental Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Episode
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study aimes at identifying whether positive expectations have an impact on the way depressive participants experience emotions in the form of sadness.


Eligibility criteria: Inclusion Criteria:

* major depression (mild to moderate)
* fluent in German language

Exclusion Criteria:

* bipolar disorder, psychotic disorder, substance dependence
* cardiovascular disease, severe kidney or liver disease, epilepsy
* change of psychotropic medication intake within the last four weeks
* allergic to capsaicin
* allergic to sesame oil
* students in medicine, pharmacy, or psychology in their third year or older
* completed studies in medicine, pharmacy or psychology

Primary outcomes:
measure: Sadness
timeFrame: Directly after watching the film sequence, no follow-up assessments
Secondary outcomes:
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: Justus Liebig University Gießen
state: Hessen
city: Marburg
country: Germany
facility: Philipps University Marburg
state: Hessen
Study officials:
affiliation: Philipps University Marburg
name: Winfried Rief, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01447069: Use of Beta-agonists in Stable Severe Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Cardiomyopathy
Non-ischemic Cardiomyopathy
Heart Failure
Keywords: heart failure stage 3
beta 2 agonist
N-terminal pro-brain natriuretic peptide
ejection fraction <35%
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2011-10-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Salbutamol is effective in the treatment of severe heart failure due to ischemic and non- ischemic cardiomyopathy.


Eligibility criteria: Inclusion Criteria:

* Ambulatory Patients with a diagnosis of ischemic and non-ischemic cardiomyopathy with a measured EF \<35%, class III as defined by the NYHA with ICD and who receive optimal pharmacological therapy.

Exclusion Criteria:

* Heart Failure class I, II, IV
* atrial fibrillation
* any significant valvular disease
* chronic obstructive pulmonary disease who treated with inhaled β2 agonist
* significant kidney disease with eGFR \<30%
* severe uncontrolled electrolyte abnormalities
* prior allergic reaction to Salbutamol
* Pregnancy and nursing women

Primary outcomes:
measure: Changes in plasma level of N-terminal pro-BNP at twelve weeks relative to baseline pro-BNP.
timeFrame: 12 weeks from baseline pro-BNP assessment
Secondary outcomes:
measure: Adverse cardiovascular event: Death, ICD discharge, significant ventricular arrhythmias and hospitalization due to heart failure exacerbation
timeFrame: 12 weeks after baseline assessment
measure: NYHA class changes
timeFrame: 12 weeks after baseline assessment
measure: Echocardiography parameters changes
timeFrame: 12 weeks after baseline assessment
measure: Minnesota Living with Heart Failure Questionnaire changes
timeFrame: 12 weeks after baseline assessment
measure: Non-ventricular arrhythmias and electrolytes disturbances
timeFrame: baseline, 1 week, 4 weeks, 8 weeks and 12 weeks
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin medical center
Study officials:
References:
Clinical trial NCT02493569: A Multicenter Study of Clinical Epidemiology of Breast Cancer in Shaanxi Province of China
Official title: A Multicenter Study of Clinical Epidemiology of Breast Cancer in Shaanxi Province of China (Based on Hospital)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Breast cancer, hospital, epidemiology, diagnosis, treatment
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2015-07-09
Enrollment: 3000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The female breast cancer patients in Shaanxi Province of China, those study population shoud be the hospitalized patients who are confirmed of the primary breast cancer histologically, moreover, the date of the inpatients are within the month we chosen and those inpatients should have been received or under receiving the relevant treatment including surgical treatment, chemotherapy and radiotherapy.

Brief summary: The purpose of the study is to study the epidemic features and diagnosis of female breast cancer, especially the diagnosis and treatment of breast cancer.The disease-free survival (DFS) and the total survival time(OS) of the breast cancer patients will also be studied.

Detailed description: The study is a multicentric, retrospective clinical study based on the hospital. The target number of cases are X patients who are eligible for breast cancer after radical mastectomy. To collect the clinicopathological data and treatment data of the breast cancer patients and do the follow-up visit of all the patients who are included in the study.

Eligibility criteria: Inclusion Criteria:

* Female patients;
* The hospitalized patients who are confirmed of the primary breast cancer histologically;
* The date of the inpatients are within the month we chosen;
* Patients who are within the month we chosen have been received or under receiving the relevant treatment including surgical treatment, chemotherapy and radiotherapy.

Exclusion Criteria:

* Male breast cancer patients;
* Patients with breast cancer who are not under the chosen time;
* Non hospitalized patients.

Primary outcomes:
measure: Overall five-year survival for the female breast cancer patients
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Yu Ren, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06663969: Evaluating Modulation Effects of Temporal Interference Using SEEG
Official title: Evaluating Modulation Effects of Temporal Interference Using SEEG
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deep Brain Stimulation
Drug Resistant Epilepsy
Keywords: Temporal Interference
Stereoelectroencephalography
Drug Resistant Epilepsy
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This single-center prospective study aims to investigate the electrophysiological mechanisms of temporal interference (TI) in humans by analyzing clinical, imaging, and electrophysiological data from patients aged 14-60 with drug-resistant epilepsy.

Detailed description: Temporal Interference (TI) technology is a novel non-invasive method for deep brain stimulation (DBS). By generating an overlapping electric field from safe currents, TI creates focused stimulation in targeted deep brain areas. This approach allows for the exploration of deep brain nuclei functions and has the potential to serve as a non-invasive alternative to traditional invasive DBS for clinical treatments.

Stereoelectroencephalography (SEEG) is a method for recording electrical activity from deep brain structures using implanted depth electrodes to provide a three-dimensional view of neuronal activity.

This study aims to investigate the electrophysiological mechanisms of temporal interference (TI) deep brain stimulation by including patients aged 14-60 with implanted intracranial electrodes. During and after TI stimulation, electrophysiological and clinical data will be recorded. Clinical, imaging, and electrophysiological data will be analyzed and processed to advance understanding of TI's effects in deep brain stimulation.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of drug-resistant epilepsy;
* No severe systemic diseases;
* Implantation of stereotactic electrodes;
* Agreement to participate in this study and signs the informed consent form.

Exclusion Criteria:

* Hematoma at the scalp electrode site or fluid accumulation under the electrode after intracranial electrode placement.

Primary outcomes:
measure: Electrophysiological changes
timeFrame: During the trial(up to 3 hours for each subject)
Secondary outcomes:
measure: Patient's subjective feelings and symptoms
timeFrame: During the trial(up to 3 hours for each subject)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital,Capital Medical University
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Liankun Ren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06309069: Calcified Cerebral Embolism: a Descriptive Study in a Large Single Center Cohort
Official title: Calcified Cerebral Embolism: a Descriptive Study in a Large Single Center Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Calcified Cerebral Embolism
Keywords: calcified cerebral embolism
cerebral infarction
radiological characteristics
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with CEE treated with intravenous thrombolysis (IVT) between 2015 and 2020, and patients with AIT/stroke with a CCE identified on CT between deceber 2019 and april 2023.

Brief summary: Calcified cerebral embolism (CCE) is a relatively rare but underdiagnosed cause of infarction. CCE diagnosis is made by CT. Radiological characteristics of CCE have been reported in small case series. The aim of this study was to describe clinical and radiological characteristics of CCE in a large number of patients, and to compare patients with different radiological CCE characteristics.


Eligibility criteria: Inclusion Criteria:

* Patients with CEE treated with intravenous thrombolysis (IVT) between 2015 and 2020 managed at the CHU de Nîmes or Patients with TIA/stroke with ECC identified on CT between 12/2019 and 04/2023 managed at CHU de Nîmes

Exclusion Criteria:

* Patient's refusal to use his/her data

Primary outcomes:
measure: Calcified aortic brachiocephalic
timeFrame: baseline
measure: cardiovascular risk
timeFrame: baseline
measure: history of stroke
timeFrame: baseline
measure: Population
timeFrame: baseline
measure: Population
timeFrame: baseline
measure: history of surgical/endovascular cardiovascular intervention
timeFrame: baseline
measure: NIHSS
timeFrame: baseline
measure: calcified aortic arch
timeFrame: baseline
measure: calcified carotid
timeFrame: baseline
measure: atherosclerotic plaques
timeFrame: baseline
measure: calcified aortic valves
timeFrame: baseline
measure: calcified mitral valves
timeFrame: baseline
measure: CCE diameter
timeFrame: baseline
measure: density
timeFrame: baseline
measure: involved cerebral artery
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Anissa MEGZARI
role: STUDY_DIRECTOR
References:
Clinical trial NCT05471869: Computational Imaging Research Based on Deep Learning
Official title: Computational Imaging Using Pixel-level Graph Adversarial Learning
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arterial Aneurysm
Keywords: Arterial Aneurysm
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: varity of people

Brief summary: Computational imaging research based on deep learning

Detailed description: Based on the current technical challenges, subject development and upgrade of knowledge, to avoid the occurrence of adverse medical accidents, simplify the diagnostic process, artificial intelligence has become the alternative method of choice, by constructing training deep learning model, the CTA as model inputs aneurysm detection and diagnosis to improve diagnosis effectiveness, promote the development of medical technology

Eligibility criteria: Inclusion Criteria:

1. Age: 18-80 years.
2. CT paired imaging data of vessels, including layer-to-layer plain CT and enhanced CT. 2 Time range: January 2010 to December 2021.
3. Scanning sites: CT and CTA of head, neck, chest, abdomen or iliac.

Exclusion Criteria:

1. Unpaired CT image .
2. Severe artifact CT image.
3. enhancement CT failure image (failure to capture arterial phase or poor arterial development, insufficient flow of contrast agent, etc.)

Primary outcomes:
measure: Objective evaluation
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
References:
Clinical trial NCT04057469: Tulobuterol Patch in Pediatric Patients Undergoing Tonsillectomy
Official title: Effect of Tulobuterol Patch Versus Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tonsillar Hypertrophy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Severance Hospital
First posted: 2019-08-15
Enrollment: 182
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: * Tonsillectomy is a common pediatric procedure for the treatment of sleep-disordered breathing and chronic tonsillitis. Up to half of children having this procedure experience a perioperative respiratory adverse event.
* We tried to determine whether tulobuterol patch (transdermal bronchodilator) premedication decreases the risk of perioperative respiratory adverse events in children undergoing anesthesia for tonsillectomy.


Eligibility criteria: Inclusion Criteria:

* pediatric patients undergoing tonsillectomy

Exclusion Criteria:

* recent upper respiratory infection (2weeks)
* Allergy to tulobuterol patch
* Patients receiving catecholamine (epinephrine, isoproterenol)
* hyperthyroidism
* hypertension
* cardiac disease
* Diabetes melitus
* atopic dermatitis
* Asthma

Primary outcomes:
measure: perioperative respiratory complication
timeFrame: from anesthetic induction to postanesthesia care unit discharge, an average of 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Hyun-Joo Kim
city: Seoul
country: Korea, Republic of
facility: Jin-Kyung Kim
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
References: