louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02277353: Evaluation of SVV From NICOM as a Predictor of Fluid Responsiveness in Prone Position During Spine Surgery
Official title: Evaluation of Stroke Volume Variation Derived From NICOM as a Predictor of Fluid Responsiveness in Prone Position During Spine Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid Responsiveness
Prone Position
Non Invasive Cardiac Output Monitoring
Keywords: Fluid responsiveness
NICOM
Prone Position
Stroke Volume Variation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2014-10-29
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing spine surgery under general anesthesia in prone position

Brief summary: NICOM® is a recently developed noninvasive cardiac output monitoring device, and indices derived from NICOM® such as SVV has been reported to predict fluid responsiveness in the previous studies. However, its usefulness in prone positioning has not been investigated. Thus, the aim of this prospective observational study is to evaluate the usefulness of stroke volume variation (SVV) derived from NICOM® to predict fluid responsiveness in prone patients undergoing spine surgery.


Eligibility criteria: Inclusion Criteria:

* ASA I or II patients undergoing spine surgery in prone position

Exclusion Criteria:

* Pre-existing arrhythmic disorders/moderate to severe valvular heart disease/obstructive pulmonary disease (COPD grade \>2), left ventricular dysfunction with LV EF less than 50, preoperative need for inotropics or vasopressors
* BMI \>30kg/m\^2 or \<15kg/m\^2
* Preoperative serum Cr \> 1.3mg/dL
* Patients with coagulopathy

Primary outcomes:
measure: Stroke volume variation from NICOM®
timeFrame: 5 min after infusion of bolus fluid
Secondary outcomes:
measure: pulse pressure variation and stroke volume variation from Flotrac/Vigileo system
timeFrame: 5 min after infusion of bolus fluid
Other outcomes:
measure: TPR (total peripheral resistance), TPRI (total peripheral resistance index)
timeFrame: 5 min after infusion of bolus fluid
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Seoul Hospital, Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jeong Jin Min, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00282451: Effect of Biphasic Insulin Compared to Biphasic Insulin Combined With Insulin Aspart, With or Without Metformin in Type 2 Diabetes
Official title: Comparison of Biphasic Insulin Aspart 30 Twice Daily With Biphasic Insulin Aspart 30 Twice Daily Plus Lunchtime Injection of Insulin Aspart, in Combination With or Without Metformin (for Both Treatment Groups) in Subjects With Type 2 Diabetes. A Multi-center, Randomized, Open-labeled, Two-armed Parallel Group Trial in Subjects With Type 2 Diabetes Previously Treated With Conventional Biphasic Human Insulin 30/70
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2006-01-26
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Africa and Middle East. The objective of the study is to compare glycemic control of Biphasic insulin Aspart 30 twice daily with Biphasic insulin Aspart 30 twice daily plus Insulin Aspart, both insulin treatments with or without metformin, in subjects with type 2 diabetes, previously treated with Biphasic Human Insulin 30/70.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic subjects
* Current treatment with Biphasic Human Insulin 30/70 twice daily alone or in combination with any oral hypoglycaemic agent for at least 3 months prior to entering the trial
* HbA1c at least 12%
* Willing and able to perform self blood glucose monitoring (SMBG)

Exclusion Criteria:

* History of drug or alcohol dependence
* Receipt of any investigational drug within the last month prior to this trial
* Anticipated change in dose of prescription medication, which may influence glucose regulation (Mono Amino Oxidase-inhibitors, non selective beta-adrenergic agents, anabolic steroids and systemic glucocorticoids)
* Severe uncontrolled hypertension
* Recurrent severe hypoglycemia as judged by investigator
* Any disease or condition, which the Investigator feels, would interfere with the trial

Primary outcomes:
measure: HbA1c
timeFrame: At Visit 6 (14 weeks)
Secondary outcomes:
measure: Postprandial glucose concentration increments (calculated based on 7-point blood glucose profiles)
Other outcomes:
Locations:
city: Aghakhan
country: Egypt
facility: Novo Nordisk Investigational Site
city: Giza
country: Egypt
facility: Novo Nordisk Investigational Site
city: Jeddah
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
city: Riyadh
country: Saudi Arabia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00257751: Different Regimen of Aprotinine(Trasylol) Administration in Patients Receiving Antiplatelet Therapy With Clopidogrel (Plavix)
Official title: Different Regimen of Aprotinine(Trasylol) Administration in Patients Receiving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2005-11-23
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clopidogrel (Plavix), a platelet ADP receptor antagonist, has become the standard of care to prevent thrombosis in interventional cardiology and is increasingly being used in unstable angina and NSTEMI. An increasing number of patients are referred to emergent or urgent CABG, and several studies, as well as our own experience, have shown that preoperative administration of irreversible platelets inhibitors increase the risk of bleeding complications following CABG.

Detailed description: Aprotinine (Trasylol) is a potent antifibrinolytic agent known to reduce bleeding after cardiac surgery. The most commeon practice is to give Trasylol in high doses immediately before surgery, during the operation, and during the first postoperative hours. However, it has also been shown that there is a hemostatic effect of the drug when given in a lower dose postoperatively, but this remains unclear.

Eligibility criteria: All coronary bypass operations in patients receiving Plavix within the last 7 days

Primary outcomes:
measure: Perioperative bleeding
measure: Blood transfusions
measure: Reoperation
Secondary outcomes:
measure: Difference in costs related to low/high dose
Other outcomes:
Locations:
Study officials:
affiliation: Oslo University Hospital
name: Eivind Øvrum, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06608251: Association of Plasma Metabolomic Biomarkers with Chronic Ischemic White Matter Injury
Official title: Association of Plasma Metabolomic Biomarkers with Chronic Ischemic White Matter Injury
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Myelinopathy
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: older than 45 years old and without stoke be able to cooperate with the improvement of brain MRI examination

Brief summary: The cases were screened according to the inclusion criteria, and after the patients signed the informed consent, the clinical data were collected, the imaging data were evaluated, and blood samples were taken for follow-up measurements. In the early morning of the second day after the patient was enrolled, 5mL of peripheral venous blood was drawn and sent to the neurology laboratory of our hospital for separation, and the detection of plasma metabolomics markers was performed.

Detailed description: In the early morning of the second day after the patient was enrolled, 5mL of peripheral venous blood was drawn and sent to the neurology laboratory of our hospital for separation, and the detection of plasma metabolomics markers was performed.Inluding CRP，Complete blood count，Liver and kidney function indicators，et.

Eligibility criteria: Inclusion Criteria：

1. Be older than 45 years old;
2. Patients admitted to the Department of Neurology due to headache, vertigo, anxiety, etc.;
3. There were no symptoms of neurological deficit on physical examination;
4. Able to cooperate with the improvement of brain MRI examination;
5. Sign the informed consent form.

Exclusion Criteria:

1. History of stroke, traumatic brain injury, intracranial tumor, central nervous system infection, active malignant tumor, thyroid disease, autoimmune disease, active or chronic inflammatory disease, severe liver and kidney impairment, etc.;
2. accompanied by neurological deficit symptoms;
3. refusal to participate in the study;
4. Other conditions judged by the investigator to be unsuitable for enrollment.

Primary outcomes:
measure: myelinopathy
timeFrame: 2024.06.01-2027.06.01
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Ying Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00126451: A Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed or Refractory Breast, Colorectal and Non-Small Cell Lung Cancer (0683-011)(TERMINATED)
Official title: A Phase II Clinical Study of Oral Suberoylanilide Hydroxamic Acid in Patients With Relapsed or Refractory Breast, Colorectal, and Non-small Cell Lung Cancer.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Colorectal Cancer
Non-small-cell Lung Carcinoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-08-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an investigational study to determine the response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to oral suberoylanilide hydroxamic acid (SAHA), to evaluate PET as an earlier indicator of response to SAHA as assessed by response evaluation criteria in solid tumours (RECIST) criteria and to evaluate the safety and tolerability of oral suberoylanilide hydroxamic acid.


Eligibility criteria: Inclusion Criteria:

* Patient must be 18 years or older with confirmed diagnosis of breast adenocarcinoma, colorectal carcinoma or non-small cell lung cancer
* Patients must have relapsed or refractory disease following at least one chemotherapeutic treatment regimen.
* Has a measurable, positron emission tomography (PET) assessable lesion
* Adequate blood, liver, bone marrow and kidney functions
* Has not received any chemotherapy for at least 4 weeks prior to entry in this study
* Agrees to take adequate measures to prevent pregnancy.

Exclusion Criteria:

* Patient has had prior treatment with histone deacetylase (HDAC) inhibitor.
* Patient has had treatment with investigational agents within the last 30 days.
* Patient has active infection or had intravenous (IV) antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drugs.
* Patient has HIV, hepatitis B or hepatitis C infection.
* Patient is pregnant or lactating.
* Patient has allergy to any component of the study drug.

Primary outcomes:
measure: Response rate of relapsed/refractory breast, colorectal and non-small cell lung cancer to SAHA using RECIST criteria.
Secondary outcomes:
measure: Positron emission tomography (PET) as an earlier indicator of the response to SAHA as assessed by RECIST criteria. To evaluate the safety and tolerability of SAHA for 14 days every 21 days.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Vansteenkiste J, Van Cutsem E, Dumez H, Chen C, Ricker JL, Randolph SS, Schoffski P. Early phase II trial of oral vorinostat in relapsed or refractory breast, colorectal, or non-small cell lung cancer. Invest New Drugs. 2008 Oct;26(5):483-8. doi: 10.1007/s10637-008-9131-6. Epub 2008 Apr 19.
Clinical trial NCT06421051: Transauricular Vagus Nerve Stimulation Improves Postoperative Sleep Disorders in Elderly Patients.
Official title: Transauricular Vagus Nerve Stimulation (taVNS) Improves Postoperative Sleep Disorders in Elderly Patients:a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vagus Nerve Stimulation
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 164
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative sleep disorder is one of the common complications after general anesthesia. Compared to patients of various ages, elderly patients have a much higher incidence of postoperative sleep disturbance. Postoperative sleep disorders can have many adverse effects, including cognitive impairment, altered pain perception, and emotional disorders, which are not conducive to the long-term prognosis of elderly patients. Enhancing postoperative sleep quality in older patients has become a significant public health concern in the current day due to its direct relationship to both maximizing surgical outcomes and enhancing physical health. This study intends to conduct a prospective, randomized controlled, triple-blind clinical trial on use of transauricular vagal nerve stimulation to improve sleep disorders in elderly patients after general anesthesia surgery, aiming to investigate the efficacy of transauricular vagal nerve stimulation in postoperative sleep disorders in elderly patients.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing non-craniocerebral surgery under elective general anesthesia
* Age ≥65 years old
* American society of Aneshesiologists Grade I to III
* Sign informed consent

Exclusion Criteria:

* Patients who are expected to retain tracheal intubation after surgery
* Disturbance of consciousness, mental disorder, inability to cooperate
* Expected survival \< 3 months
* The estimated operation time is \< 2 hours
* The expected postoperative hospital stay is \< 5 days

Primary outcomes:
measure: Incidence of sleep disorders within 5 days after surgery.
timeFrame: Day 1 to day 5 after surgery.
Secondary outcomes:
measure: Sleep quality after surgery.
timeFrame: Day 1,3,5 after surgery.
measure: Postoperative pain score
timeFrame: Day1 and 2 after surgery.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT04322851: B-line by Lung US in Patients With Acute Decompensated Heart Failure
Official title: Implication of B-line Estimated by Lung Ultrasound on Risk of Reintubation in Mechanically Ventilated Patients With Acute Decompensated Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are on mechanical ventilation due to acute heart failure

Brief summary: The purpose of this study is to evaluate that B-line detected by lung ultrasound before extubation in patients with acute decompensated heart failure can predict future risk of reintubation and clinical outcomes during admission in Korea.


Eligibility criteria: Inclusion Criteria:

* mechanical ventilation due to acute heart failure

Exclusion Criteria:

* none

Primary outcomes:
measure: Re-intubation rate
timeFrame: within 72 hours from initial extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Minseok Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05006651: Video Laryngoscope vs. Video Stylet During General Anesthesia With Obesity Patient
Official title: Video Laryngoscope vs. Video Stylet During General Anesthesia With Obesity Patient
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation; Difficult or Failed
Obesity
Keywords: obesity
Intubation
Lead sponsor: Buddhist Tzu Chi General Hospital
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 325
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity patients are more common in recent years. They have potential difficult airway. Two different video devices are popular used in Taiwan, video larygoscope and video stylet. We compared video larygoscope (McGrath MAC) and video stylet (Trachway) during elective surgery require tracheal intubation with obesity patients. The control group is traditional laryngoscope. 325 patients would be enrolled, above 100 patient each group.


Eligibility criteria: Inclusion Criteria:

* Elective surgery needs intubation
* ASA I to III
* BMI\>30kg/m2

Exclusion Criteria:

* Head and neck cancer
* Skull, neck fracture
* Tracheal trauma
* NPO\< 8hr
* Lung disease with hypoxemia
* Mental Disorders
* Patient wouldn't be extubated after operation immediately
* Contraindicated to muscle relaxant

Primary outcomes:
measure: Time to Intubation
timeFrame: 10 minute
measure: Intubation difficulty
timeFrame: 10 minute
Secondary outcomes:
measure: Any injury during intubation
timeFrame: 24 hours
Other outcomes:
Locations:
city: Hualien City
country: Taiwan
facility: Hualien Tzu Chi Hospital
state: Hualien
Study officials:
affiliation: Hualien Tzu Chi General Hospital
name: Po-Kai Wang
role: STUDY_CHAIR
References:
Clinical trial NCT05768451: Ultrasound Radiomics for Predicting Breast Cancer and Axillary Lymph Node Metastasis
Official title: Accurate Prediction of Breast Cancer and Axillary Lymph Node Metastasis Burden by Multi-modal Ultrasound-based Radiomics
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Axillary Lymph Node Metastasis
Keywords: breast cancer
multi-modal ultrasound
radiomics
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast tumors seen in Nanjing Gulou Hospital in September 2018 and later and confirmed by histological pathology were selected, and all patients had complete preoperative US, UE and CEUS examination data.

Brief summary: The project is proposed based on multimodal ultrasonic imaging omics building used for accurate prediction of the breast cancer and axillary lymph node metastasis load artificial intelligence forecasting model, this method can dig the hidden features of ultrasonic image is not visible to the naked eye, make up the subjectivity in the process of clinical doctors in diagnosis and treatment, provide accurate, objective basis for clinical decision making.


Eligibility criteria: Inclusion Criteria:

* patients who have not received breast puncture biopsy or neoadjuvant chemotherapy, etc. prior to ultrasonography;
* patients who are not allergic to the ultrasound contrast agent (SonoVue) and have signed an informed consent form for ultrasonography
* patients with breast tumors who have undergone surgical treatment at our hospital and have complete case histories.

Exclusion Criteria:

* patients with incomplete case data;
* cases with large breast masses that do not completely show the region of interest (ROI);
* patients who have undergone breast aspiration biopsy or other treatments such as neoadjuvant chemotherapy or endocrine therapy before ultrasound examination.

Primary outcomes:
measure: Accuracy of differential diagnosis between benign and malignant
timeFrame: 2022.12.15-2023.12.30
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04324151: Pembrolizumab Combined With Double Platinum Based Chemotherapy for Potentially Resectable NSCLC
Official title: Pembrolizumab Combined With Double Platinum Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer

Brief summary: This study aims to explore the efficacy and safety of Pembrolizumab Combined With Double Platinum-Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer

Detailed description: Inclusion criteria:

diagnosed with Non-small cell lung cancer EGFR and ALK and ROS1 negative Treatment naive Potentially Resectable identified by MDT

Eligibility criteria: Inclusion Criteria:

* ≥18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology
* Potentially Resectable NSCLC
* Treatment Plan is Crizotinb or Standard Chemotherapy

Exclusion Criteria:

* Patients with contraindication of chemotherapy
* Pregnant or breast feeding women

Primary outcomes:
measure: PFS
timeFrame: may 2020- may 2021 (1 year)
Secondary outcomes:
measure: OS
timeFrame: may 2020- may 2021 (1 year)
measure: ORR
timeFrame: may 2020- may 2021 (1 year)
Other outcomes:
Locations:
city: Changsha
country: China
facility: Yongchang Zhang
state: Hunan
Study officials:
affiliation: Hunan Cancer Hospital
name: Yongchang Zhang
role: PRINCIPAL_INVESTIGATOR
References: