louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02327611: CUstodiol Versus RInger: whaT Is the Best Agent?
Official title: CUstodiol Versus RInger: whaT Is the Best Agent? A Randomized Double Blind Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thoracoabdominal Aortic Aneurysms
Lead sponsor: Scientific Institute San Raffaele
Sponsor class: OTHER
First posted: 2014-12-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative renal failure is the most significant risk factor for early mortality after elective surgical repair of thoracoabdominal aortic aneurysms (TAAAs).

To prevent damages related to kidney ischemia during aortic crossclamping and TAAA repair, the most recent guidelines recommend the use of cold crystalloid or blood perfusion. Since the most studied crystalloid solution is the Ringer's lactate solution, this can be considered the standard of care for evaluating the effectiveness of other substrates.

An histidine-tryptophan-ketoglutarate enriched crystalloid solution named Custodiol (Dr. Franz Kohler Chemie GmbH, Bensheim, Germany) is currently used for organ preservation during transplantation and for cardioplegia during open-heart surgery in most EU countries. This solution may provide a better grade of renal protection to ischemic damage than the standard crystalloid solutions.

A recent observational study published by our group suggested a lower incidence of postoperative renal kidney injury in patients undergoing open TAAA surgical repair using renal perfusion with Custodiol, as compared to those perfused with an enriched Ringer's lactate solution.

Objective of this study is the confirmation of the promising findings about the effectiveness of renal perfusion with Custodiol during repair of TAAA compared with other crystalloid.

The study will be a prospective, single-center, randomized, double-blind, controlled trial, investigating Acute Kidney Injury in patients undergoing TAAA open repair using Custodiol renal perfusion versus an enriched Ringer's lactate solution. It is expected to enroll adult patients undergoing elective TAAA open repair. Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.


Eligibility criteria: Inclusion Criteria:

Ability to provide written informed consent; Patient undergoing open surgical repair of TAAA requiring renal perfusion.

Exclusion Criteria:

1. Patients who have participated to experimental trials during the previous 3 months
2. Intervention under emergency / urgency
3. Patient uncooperative and / or affected by mental disease
4. Allergy or intolerance to the study drug
5. Patient under renal replacement treatment (dialysis) before surgery
6. Pregnant or breast-feeding women

Primary outcomes:
measure: Acute Kidney Injury
timeFrame: Kidney function will be assessed during hospital stay (an expected average of 2 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: San Raffaele Hospital
Study officials:
References:
Clinical trial NCT04455711: The Effect of Lidocaine on Smooth Emergence With Double Lumen Tube
Official title: The Efficacy of Intravenous Lidocaine With Continuous Infusion of Remifentanil for Attenuating Double Lumen Tube Induced Cough During Emergence
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cough
Lidocaine
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 80
Sex: MALE
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Cough suppression during emergence and tracheal extubation from general anaesthesia has become an important issue as part of patient safety. Cough arised from the mechanical irritation of endotracheal tube and cuff could be accompanied by various adverse effects such as laryngospasm, hypertension, tachycardia, arrhythmia and increase of intracranial, intraocular, or intra-abdominal pressure.

Several cough-preventing strategies have been proposed for smooth emergence, such as opioids, dexmedetomidine or lidocaine. Maintenance of remifentanil infusion during emergence has been reported to be an effective method in reducing cough and cardiovascular change without delay of recovery. In previous studies, the effetive effect-site concentraions for 95% of adults (EC95) for preventing cough are a little different depending on anaestheic agent, type of surgery and sex, ranged from 2.14 to 2.94 ng/ml. However, since most of these studies are for sing lumen endotracheal tube, similar preventing effect would not be expected for double lumen tube (DLT) because of its large diameter and long length. Another problem is higher concentration of remifentanil more than 2.5 ng/ml could not guarantee the safety after extubation. The efficacy of a single IV bolus of lidocaine for the prevention of cough has been the subject of numerous trials.

Therefore, combined use of lidocaine and remifentanil could effectively prevent emergence cough for DLT without the risk of high concentration of remifentanil.


Eligibility criteria: Inclusion Criteria:

* Patients needs for double lumen tube intubation for one lung ventilation during surgery with ASA (American society of Anesthesiologists) class I or II

Exclusion Criteria:

* Gastroesophageal reflux disease
* Obese patients (BMI \> 30)
* Recent upper respiratory infection history (within 3 weeks)
* Asthma history
* Anticipating difficult airway

Primary outcomes:
measure: Cough incidence
timeFrame: from the time of end of the operation up to 10 min after extubation
Secondary outcomes:
measure: Cough severity
timeFrame: from the time of end of the operation up to 10 min after extubation
measure: hoarseness
timeFrame: 30 min at the recovery room
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggido
Study officials:
affiliation: Ajou University School of Medicine
name: Ji young Yoo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00510211: An Observational Study of Olanzapine Coated and Orodispersible Tablets Effectiveness in Schizophrenic and Bipolar Outpatients.
Official title: An Observational Study of Olanzapine Coated and Orodispersible Tablets Effectiveness in Schizophrenic and Bipolar Outpatients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Bipolar Disorder
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2007-08-01
Enrollment: 1131
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: Patients observed in outpatient settings (ambulatory and community)

Brief summary: The primary objective of this study is to assess the proportion of schizophrenic patients and the proportion of bipolar patients who discontinue olanzapine within 12 months of treatment in outpatient, ambulatory or community settings


Eligibility criteria: Inclusion Criteria:

* patients suffering from schizophrenic or schizoaffective disorders based on the disease diagnostic criteria DSM IV and being prescribed olanzapine during the 45 preceding days.
* patients suffering from bipolar disorders based on the disease diagnostic criteria DSM IV and being prescribed olanzapine during the 45 preceding days for one of the following:
* moderate or severe manic episode
* relapse prevention in patients with bipolar disorder

Exclusion Criteria:

* current treatment with any investigational drug or procedure at entry or during the whole study
* hypersensitivity to olanzapine
* patients with known narrow angle glaucoma risk

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Bad Homburg
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Thessaloniki
country: Greece
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-615-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04254211: Neutrophil-lymphocyte Ratio and Platelet-lymphocyte Ratio as Predictors for Adverse Events in EVAR
Official title: Neutrophil-lymphocyte Ratio and Platelet-lymphocyte Ratio as Predictors for Adverse Events in Endovascular Aneurysm Repair for Abdominal Aorticaneurysm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammation in EVAR
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 230
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included consecutive AAA patients treated electively by EVAR

Brief summary: This study investigated the association of chronic inflammatory markers with the clinical outcome after endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm.

Detailed description: The study included 230 consecutive AAA patients, treated electively by EVAR from March 2016 to February 2019. The values of simple inflammatory markers,neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR), were measured pre- and postoperatively.Adverse events included any major adverse cardiovascular events (MACE), acute kidney injury and death from any cause.

Eligibility criteria: Inclusion Criteria:

* AAA
* Elective
* EVAR

Exclusion Criteria:

* Emergency
* Open surgery

Primary outcomes:
measure: NLR major cardiovascular events (MACE)
timeFrame: Day 4 postopertively
measure: PLR major cardiovascular events (MACE)
timeFrame: Day 4 postopertively
measure: NLR acute kidney injury (AKI)
timeFrame: Day 4 postopertively
measure: PLR acute kidney injury (AKI)
timeFrame: Day 4 postopertively
measure: NLR death
timeFrame: Day 4 postopertively
measure: PLR death
timeFrame: Day 4 postopertively
Secondary outcomes:
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Univeristy of Thessaly
state: Thessaly
Study officials:
affiliation: University of Thessaly
name: Elena Arnaoutoglou, MD, PhD
role: STUDY_CHAIR
affiliation: University Hospital of Larissa
name: Maria Ntalouka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01870011: A Comparison of Propofol Based Total Intravenous Anesthesia and Desflurane Based Balanced Anesthesia on Renal Protection During Deceased Brain Dead Donor Kidney Transplantation - A Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: End Stage Renal Disease
Keywords: Propofol, renal protection, kidney transplantation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Renal ischemia/reperfusion (I/R)-induced injury is known to be associated with immediate and long-term kidney dysfunction after renal transplantation. Protecting the kidney against I/R injury and maintaining renal function during renal transplant surgery is therefore very important in order to improve post-operative outcome. This purpose of this study is to investigate whether propofol anesthesia done in both kidney donors and recipients during deceased brain dead donor kidney transplantation is effective in reducing renal I/R injury via its antioxidant and antiinflammatory properties and improve post-transplant outcome compared to desflurane anesthesia.


Eligibility criteria: Inclusion Criteria:

* Adult deceased brain dead kidney donors and recipients scheduled for renal transplantation

Exclusion Criteria:

1. Donor exclusion criteria:

(1) Refusal of legal guardian

2. Recipient exclusion criteria:

1. Patient refusal
2. Hypersensitivity to propofol, soybeans or peanuts
3. History of vitamin C or E intake within 5 days before surgery
4. History of acute myocardial infarct within 6 months before surgery
5. Congestive heart failure (NYHA III-IV)
6. Autoimmune disease patients
7. BMI over 30 kg/m2
8. Left ventricular ejection fraction less than 35% upon preoperative echocardiography

Primary outcomes:
measure: The difference in inflammatory markers of recipients between groups during and after renal transplantation (CRP, WBC differential count, IL-6, TGF-β)
timeFrame: Inflammatory markers are evelauted immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction
Secondary outcomes:
measure: The difference in renal function of kidney recipients between groups after renal transplantation (BUN/Cr, cystatin C, NGAL)
timeFrame: immediately after anesthesia induction, right before kidney extraction and 1 hour after kidney extraction
Other outcomes:
measure: The difference in global oxidative stress markers of recipients between groups during and after renal transplantation (Free Oxygen Radicals Testing, Free Oxygen Radial Defense)
timeFrame: changes of Global oxidative stress markers from Immediately after anesthesia induction to 2 hours after reperfusion
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT06134011: A Multi-omics-based Metabolic Typing Study of Gastric Cancer
Official title: Clinical Study on Metabolic Typing of Gastric Cancer Based on Transcriptome, Metabolome and Other Multi-omics
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Gastric Cancer
Multi-omics
Diagnosis
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: These cases have histologically or cytologically confirmed gastric cancer and there are no other tumors

Brief summary: In the study, the investigators obtained gastric cancer tissues from 480 gastric cancer patients who had undergone surgery at the Zhejiang Cancer Hospital's biospecimen bank between 2012-2019, and obtained relevant clinical information. The gastric cancer tissues were subjected to transcriptomic, metabolomic and other multi-omics testing, and analyzed for the metabolic changes of gastric cancer, and proposed to discover relevant therapeutic targets.


Eligibility criteria: Inclusion Criteria:

* 18≤age≤80
* Histologically or cytologically confirmed gastric cancer
* Undergo surgery for radical or palliative gastric cancer (both open and laparoscopic)
* Patients with survival follow-up information

Exclusion Criteria:

* Two or more kinds of malignant tumors at the same time
* Incomplete or missing case information
* Preoperative diagnosis of residual gastric cancer

Primary outcomes:
measure: The differences of the metabolism information
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
state: Zhejiang
Study officials:
References:
citation: Li S, Yuan L, Xu ZY, Xu JL, Chen GP, Guan X, Pan GZ, Hu C, Dong J, Du YA, Yang LT, Ni MW, Jiang RB, Zhu X, Lv H, Xu HD, Zhang SJ, Qin JJ, Cheng XD. Integrative proteomic characterization of adenocarcinoma of esophagogastric junction. Nat Commun. 2023 Feb 11;14(1):778. doi: 10.1038/s41467-023-36462-8.
citation: Shi W, Wang Y, Xu C, Li Y, Ge S, Bai B, Zhang K, Wang Y, Zheng N, Wang J, Wang S, Ji G, Li J, Nie Y, Liang W, Wu X, Cui J, Wang Y, Chen L, Zhao Q, Shen L, He F, Qin J, Ding C. Multilevel proteomic analyses reveal molecular diversity between diffuse-type and intestinal-type gastric cancer. Nat Commun. 2023 Feb 14;14(1):835. doi: 10.1038/s41467-023-35797-6.
citation: Wang J, Kunzke T, Prade VM, Shen J, Buck A, Feuchtinger A, Haffner I, Luber B, Liu DHW, Langer R, Lordick F, Sun N, Walch A. Spatial Metabolomics Identifies Distinct Tumor-Specific Subtypes in Gastric Cancer Patients. Clin Cancer Res. 2022 Jul 1;28(13):2865-2877. doi: 10.1158/1078-0432.CCR-21-4383.
Clinical trial NCT02750111: Continuous Glucose Monitoring During Intecorse in Young Adults With Type 1 Diabetes
Official title: Continuous Glucose Monitoring During Intecorse in Young Adults With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus Type 1
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Sheba Medical Center
First posted: 2016-04-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 1 diabetes

Brief summary: Determine the incidence of hypoglycemia during / after sexual intercourse among young adults with type 1 diabetes using continuous -type sugar meter IPRO for a week.

Detailed description: Determine the incidence of hypoglycemia during / after sexual intercourse among young adults with type 1 diabetes using continuous -type sugar meter IPRO for a week.

Eligibility criteria: Inclusion Criteria:

type 1 diabetes

Exclusion Criteria:

type 2 diabetes other concomitant disease

Primary outcomes:
measure: Blood Glucose
timeFrame: week
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba_Medical_Center
Study officials:
affiliation: Sheba Medical Center
name: Orit Hamiel, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02390193: Effect of Hemodialysis on Upper Airways Collapsibility in Patients With Chronic Kidney Disease
Official title: Effect of Hemodialysis on Upper Airways Collapsibility in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Insufficiency, Chronic
Keywords: Chronic kidney disease
Dialysis
Sleep
Pulmonary function
Polysomnography
Upper airway
Lead sponsor: Centro Universitário de Anapolis
Sponsor class: OTHER
Collaborators: name: Irmandade da Santa Casa de Misericordia de Sao Paulo
First posted: 2015-03-17
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Introduction: Currently, chronic kidney disease (CKD) is one of the most serious public health problems, becoming a global epidemic. It is also known that the amount of displacement of overnight rostral fluid, from the lower limbs, is related to increased neck circumference and severity of obstructive sleep apnea (OSA) in patients with end-stage renal disease. Method / Design: A clinical trial study aiming to assess the degree of collapsibility of the upper airway in patients with CKD undergoing hemodialysis has been proposed. The test of the negative expiratory pressure and nocturnal polysomnography will be performed before and after the hemodialysis session. Discussion: The incidence of CKD has increased, due to the increased number of cases of diabetes mellitus and hypertension. Our hypothesis is that the weight gain due to volume overload, observed in the interdialytic period, will exert a negative influence on the degree of collapsibility of the upper airways predispose to OSA in CKD patients.


Eligibility criteria: Inclusion Criteria:

* male or female patients aged 18 to 80 years;
* chronic kidney failure;
* candidate for kidney transplant with indication for dialysis;
* cognitive level sufficient for understanding the procedures and following the instructions;
* absence of dementia or treatment-refractory psychiatric diseases leading to an inability to provide informed consent.
* and agreement to participate by signing a statement of informed consent.

Exclusion Criteria:

* craniofacial abnormalities;
* undergoing active treatment of sleep apnea;
* active malignancy;
* active alcohol and/or drug abuse;

Primary outcomes:
measure: Collapsibility of the upper airway.
timeFrame: 06 months
Secondary outcomes:
measure: Prevalence and severity of sleep disorders
timeFrame: 06 months
measure: Change in pulmonary function.
timeFrame: 06 months
Other outcomes:
Locations:
city: Anápolis
country: Brazil
facility: Centro Universitário de Anápolis - UniEVANGÉLICA
state: GO
Study officials:
affiliation: Centro Universitário de Anápolis - UniEVANGÉLICA
name: Luis VF Oliveira, PhD
role: STUDY_CHAIR
References: