louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04187638: Effect of Olive Oil Consumption on Cardiovascular Biomarkers
Official title: Effect of Olive Oil Consumption on Cardiovascular Biomarkers in Asians and Caucasians: A Randomized, Crossover, Controlled Interventional Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Risk Factor
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomized, double-blind, placebo-controlled crossover trial.
Primary purpose: TREATMENT

Brief summary: The main aim of this study is to examine the effect of olive oil consumption on several cardiovascular risk markers between Caucasians and Asian ethnicity. The primary assessments: endothelial function's biomarkers: cell and vascular adhesion molecules (ICAMs and VCAMs) and nitric oxide (NO). The secondary assessments: Lipid profile.


Eligibility criteria: Inclusion Criteria:

Male

Orient Asians (including Chinese, Japanese, Korean, and Malaysia Chinese) and Caucasians

Age 18-70 years

Self-reported in good general health

Exclusion Criteria:

Female

Age older than 70 years or younger than 18 years

Diagnosed and/or are taking medications for hypertension (\>140/90mmHg)

Diabetes

High blood cholesterol

Heart problems (e.g. arrhythmia, high-grade stenosis of the carotid artery or carotid sinus syndrome)

Allergy to olive oil or olive oil products

Lactose intolerance

Taking omega-3 supplements in fish oil and vitamins supplements in the last six months.

Primary outcomes:
measure: changes in ambulatory blood pressure
timeFrame: Baseline and 2 weeks
Secondary outcomes:
measure: Changes in plasma total cholesterol
timeFrame: Baseline and 2 weeks
measure: Changes in Intercellular Adhesion Molecule 1
timeFrame: Baseline and 2 weeks
measure: Changes in vascular cell adhesion molecule 1
timeFrame: Baseline and 2 weeks
measure: Changes in C-reactive protein
timeFrame: Baseline and 2 weeks
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Department of Applied Sciences, Faculty of Health and Life Sciences, Northumbria University
Study officials:
References:
Clinical trial NCT06752538: Assessment of Robotic Versus Laparoscopic Gastrectomy for GC Patients With Intraoperative Technical Complexity
Official title: Assessment of Robotic Versus Laparoscopic Gastrectomy for Gastric Cancer Patients With Intraoperative Technical Complexity: A Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrectomy for Gastric Cancer
Robotic Surgical Procedures
Laparoscopic Surgical Procedures
Keywords: Surgical difficulty
Gastrectomy
Robotic
Laparoscopic
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2024-12-30
Enrollment: 3534
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: Patients with pathologically confirmed T1-4aN0-3bM0 gastric adenocarcinoma who underwent radical RG or LG between August 2016 and June 2019 at eight high-volume tertiary teaching hospitals in China

Brief summary: While robotic gastrectomy (RG) is increasingly used in gastric cancer surgery, its potential advantages over laparoscopic gastrectomy (LG) in Intraoperative technical complexity (ITC) cases remain debated.

Detailed description: This retrospective cohort study included 3,534 patients with gastric cancer who underwent radical gastrectomy at eight high-volume hospitals. ITC was defined by any of the following criteria: operative time exceeding the third quartile, intraoperative estimated blood loss ≥ 400 mL, or conversion to open surgery. Propensity score matching (PSM) and inverse probability of treatment weighting (IPTW) were conducted to compare short- and long-term outcomes.

Eligibility criteria: Inclusion Criteria:

* Patients with postoperatively histologically confirmed T1-4aN0-3bM0 gastric adenocarcinoma who underwent RG or LG

Exclusion Criteria:

* Remnant gastric cancer
* Previous malignant
* ASA class \>3
* Use of indocyanine green
* Neoadjuvant chemotherapy
* Loss to follow-up
* Combined resection

Primary outcomes:
measure: Overall survival
timeFrame: Within 3 years after surgery
Secondary outcomes:
measure: recurrence
timeFrame: 36 months
measure: Postoperative complications
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Chang-Ming Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06536738: Esophageal Fistula After Anterior Cervical Decompression and Fusion
Official title: Esophageal Fistula After Anterior Cervical Decompression and Fusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Fistula
Lead sponsor: Taizhou Hospital
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients secondary esophageal fistula following anterior cervical decompression and fusion surgery.

Brief summary: This study aims to evaluate the incidence, risk factors, and preventive measures of esophageal fistula following anterior cervical decompression and fusion. By understanding the mechanisms and clinical manifestations of this complication, the study seeks to provide clinicians with better guidelines for treatment and improve postoperative outcomes for patients.


Eligibility criteria: Inclusion Criteria:

Patients aged 18 and older. Diagnosed with a secondary esophageal fistula following anterior cervical decompression and fusion surgery.

Postoperative confirmation of the esophageal fistula via imaging studies or endoscopy.

Presence of clinical symptoms such as dysphagia, coughing, or signs of infection.

Patients or their legal representatives must provide informed consent.

Exclusion Criteria:

Preexisting esophageal diseases such as esophageal cancer, severe esophagitis, or congenital anomalies.

Other types of fistulas not related to the surgery. Severe comorbid conditions, including: Uncontrolled diabetes, severe cardiovascular diseases, immunosuppression, pregnant women.

Individuals unable or unwilling to comply with study protocols. Life expectancy of less than six months due to other underlying health conditions.

Primary outcomes:
measure: The healing rate after the repair of an esophageal fistula
timeFrame: 2 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05123638: VR vs. Conventional Cycling Exercise for Geriatric Inpatient Physical Activation
Official title: Is Virtual Reality Assisted Cycling Exercise Superior to Conventional Stationary Cycling in Geriatric Patients for Increasing Physical Activity Levels During Hospitalization?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inactivity, Physical
Treatment Adherence and Compliance
Hospital Acquired Condition
Sarcopenia
Keywords: Virtual Reality
Patient Preference
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2021-11-17
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stratified randomization (based os Cumulated-Ambulation Score of 6 vs. \<6) of geriatric inpatients to either VR assisted stationary cycling exercise or conventional stationary cycling exercise.
Primary purpose: OTHER

Brief summary: The aim of this study is to investigate whether virtual reality assisted stationary cycling exercise results in more physical activity than conventional unsupervised stationary cycling exercise. Physical activity levels are reported for both exercise duration and volume and non-exercise activity.


Eligibility criteria: Inclusion Criteria:

* Admitted to geriatric ward at Bispebjerg Hospital with an minimum of 3 days (anticipated) left of stay.
* Volunteering

Exclusion Criteria:

* Unable to be easily mobilized by training staff.
* Unable to perform the stationary cycling exercise modality.
* Lack of Danish speaking and reading skills.
* Lack of senses (blind, deff pr heavily hearing impaired).
* Suffering from delirium, vertigo or dementia beyond a moderate degree.
* Judged medically contraindicated by therapeutic, medical or care staff

Primary outcomes:
measure: Voluntary exercise duration
timeFrame: 3-14 days
Secondary outcomes:
measure: Voluntary exercise amount
timeFrame: 3-14 days
measure: Measures of 24 hour physical activity and sedentary behavior
timeFrame: 3-14 days
Other outcomes:
Locations:
city: Bispebjerg
country: Denmark
facility: Bispebjerg Geriatric Ward
Study officials:
affiliation: CopenAge
name: Charlotte Suetta
role: STUDY_DIRECTOR
References:
Clinical trial NCT03337438: Alcohol and Health: Personalized Feedback
Official title: Alcohol and Health: Personalized Feedback
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Alcohol Consumption, Youth
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Heavy episodic drinking (HED) among college students remains a concern within the U.S., as rates of HED are still high in this population. Though a variety of brief motivational interventions for alcohol use in college students have demonstrated significant effects, these effects are often small and not consistently maintained over time. Personalized feedback interventions (PFIs) are a particularly promising approach, as these are often acceptable to college students, as well as low-cost, and easy to disseminate. Though presentation of interperson discrepancy via descriptive and injunctive norms has shown consistent effects within PFIs and received much attention in the literature, intraperson, or ideal-actual self discrepancies, has largely been ignored. Drawing from cognitive dissonance theory, self-regulation theory, and motivational interviewing, the current study aims to evaluate the efficacy of an alcohol PFI with a values component to incorporate ideal-self discrepancy into a typical intervention.


Eligibility criteria: Inclusion Criteria:

* Must be at least 18 years of age
* Must be able to speak and read English
* Must report consuming alcohol in a typical week over the past month

Exclusion Criteria:

* Must not deny drinking within the past month
* Non-English speaking
* Under the age of 18

Primary outcomes:
measure: Alcohol consumption
timeFrame: one-month post baseline
measure: Alcohol consequences
timeFrame: one month post-baseline
measure: Value-behavior discrepancy for values related to alcohol use
timeFrame: one month post-baseline
Secondary outcomes:
measure: Perceptions of norms
timeFrame: one month post-baseline
measure: Trait mindfulness
timeFrame: one month post-baseline
Other outcomes:
Locations:
city: Stillwater
country: United States
facility: North Murray Hall Oklahoma State University
state: Oklahoma
Study officials:
References:
Clinical trial NCT00156338: Effect of Intraoperative Fluid Management on Morbidity
Official title: Effect of Intraoperative Fluid Management on Morbidity in Patients Undergoing Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epidural Anesthesia
Keywords: Fluid therapy
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether intraoperative fluid and sodium restriction decreases postoperative morbidity


Eligibility criteria: Inclusion Criteria:

* epidural anesthesia
* ASA I-III

Exclusion Criteria:

* metastasized cancer
* pregnancy

Primary outcomes:
measure: all cause Morbidity
timeFrame: one year
Secondary outcomes:
measure: Gastral and intestinal function
timeFrame: within the first 30 days after surgery
measure: all cause Mortality
timeFrame: one year
measure: Gastral and intestinal function
timeFrame: one year after surgery
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Raphaelsklinik
city: Münster
country: Germany
facility: St. Franziskus-Hospital Münster
city: Münster
country: Germany
facility: Department of Anesthesiology and Intensive Care, University Hospital Münster
Study officials:
affiliation: Department of Anesthesiology and Intensive Care, University Hospital Münster
name: Martin Westphal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04901338: Cytokine Hemoadsorption in ECMO Patients
Official title: Cytokine Hemoadsorption in ECMO Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SIRS
Cytokine Storm
Cardiogenic Shock
Cardiac Arrest
Septic Shock
ARDS, Human
Keywords: Hemoadsorption
ECMO
SIRS
ARDS
Post-resuscitation syndrome
ECPR
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 25
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: Patients on VA ECMO or VV ECMO treated with hemoadsorption

Brief summary: Cytokine hemoadsorption is a novel therapy used to improve outcome in critically ill patients with a dysregulated cytokine response and hemodynamic instability. Patients on extracorporeal membraneous oxygenation (ECMO) often develop severe systemic inflammatory response syndrome (SIRS). Cytokine removal using different types of hemoadsorption devices is believed to block the vicious circle of inflammation dysregulation when other basic therapeutic measures fail. To date there are very limited reports on ECMO and cytokine hemoadsorption combination therapy. The aim of this retrospective study is to evaluate feasibility and effectiveness of hemoadsorption in veno-arterial and veno-venous ECMO patients.


Eligibility criteria: Inclusion Criteria:

* VA/VV ECMO
* hemoadsorption
* Age ≥ 18 years

Exclusion Criteria:

* no additional exclusion criteria after being eligible for ECMO

Primary outcomes:
measure: Haemodynamic stabilization
timeFrame: Within 12 hours after hemoadsorption
Secondary outcomes:
measure: Lactate, interleukin-6, C-reactive protein and procalcitonin clearance
timeFrame: Within 12 hours after hemoadsorption
measure: Weaning from ECMO
timeFrame: from day of ECMO-implant for every 24 hours until date of weaning or death, whichever came first, assessed up to 90 days
measure: ICU length of stay
timeFrame: from day of ICU-admission for every 24 hours until date of discharge or death, whichever came first, assessed up to 90 days
measure: Hospital mortality
timeFrame: from day of hospital admission until date of discharge or death, whichever came first, assessed up to 90 days
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Center Ljubljana
Study officials:
References:
Clinical trial NCT00285038: Ultrasound (US)-Doppler for the Diagnosis of Asymptomatic Deep Vein Thrombosis (DVT) in Gynecologic Cancer Patients
Official title: US-Doppler for the Diagnosis of Asymptomatic DVT in Gynecologic Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Vein Thrombosis
Keywords: Deep vein thrombosis
Gynecological cancer
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2006-02-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Gynecological Ambulatory cancer patients

Brief summary: The aim of this study is to determine the prevalence of asymptomatic lower extremity DVT detected by Doppler ultrasound in a selected group of patients suffering from gynecological malignancies.

Detailed description: The association between malignancy and venous thromboembolism (VTE) is well known. It has been shown that there is a high prevalence of VTE in gynecological malignancies. Early detection of VTE can identify patients who may benefit from anticoagulant therapy and prevent morbidity and mortality.

NO clear guidelines are available for anticoagulant prophylaxis in a selected group of ambulatory gynecological cancer patients. It has been shown, in other selected groups of patients that Ultrasound Doppler can be used in order to diagnose asymptomatic DVT (deep vein thrombosis).

Eligibility criteria: Inclusion Criteria:

* Gynecological cancer patients
* Ambulatory performance status of 0-2
* Prior to, or during, chemotherapy and/or radiation

Exclusion Criteria:

* Before or near surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Ministry of Health, Israel
name: Nira Beck-Razi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01604538: Italian Pulmonary Embolism Registry - IPER
Official title: Italian Pulmonary Embolism Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Pulmonary Embolism
Lead sponsor: University Of Perugia
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 1700
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 acute pulmonary embolism

Brief summary: RAZIONALE

Pulmonary embolism is a complex disease, with a highly variable clincal presentation. Diagnosis starts with clinical probability assessment mainly based on medical history and rapidly available clinical data. Pulmonary embolism can be managed by emergency department, cardiology, pneumology geriatrics or internal medicine physicians. Thus, initial clinical management can varies based on the attitude of the attending physician.

Diagnosis is a crucial point as it can influence short term mortality.

OBJECTIVE

The registry has 3 main objectives:

1. educational objective,
2. improvement in the knowledge of epidemiology, management and outcome of acute pulmonary embolism in Italy
3. scientific objective


Eligibility criteria: Inclusion Criteria:

* consecutive patients with acute pulmonary embolism

Exclusion Criteria:

* age \<18 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: San Carlo Borromeo hospital, Milan, Italy
name: Franco Casazza, MD
role: STUDY_CHAIR
References:
citation: Zuin M, Bilato C, Bongarzoni A, Zonzin P, Casazza F, Rigatelli G, Roncon L. Impact of clinical profile at admission on the outcomes in patients hospitalized for acute pulmonary embolism: data from the IPER Registry. J Thromb Thrombolysis. 2023 Jan;55(1):166-174. doi: 10.1007/s11239-022-02726-1. Epub 2022 Nov 9.
citation: Becattini C, Casazza F, Forgione C, Porro F, Fadin BM, Stucchi A, Lignani A, Conte L, Imperadore F, Bongarzoni A, Agnelli G. Acute pulmonary embolism: external validation of an integrated risk stratification model. Chest. 2013 Nov;144(5):1539-1545. doi: 10.1378/chest.12-2938.
Clinical trial NCT05724290: Mechanism of EGR2 in Allergic Rhinitis
Official title: The Regulatory Mechanism of EGR2 Mediated by miR-150-5p on Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Rhinitis, Allergic
Keywords: nasal polyps
chronic rhinosinusitis
atopic NPs
non-atopic NPs
EGR2
Lead sponsor: Zunyi Medical College
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 3
Sex: ALL
Minimum age (years): 16
Maximum age (years): 76
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: EGR2 may be a target for the treatment of nasal polyps.

Detailed description: There is much debate about the etiology of nasal polyps, so the pathogenesis of nasal polyps still needs to be clarified. Surgery for noninflammatory nasal polyps may be better control, but surgery is not effective for recurrent sinusitis and nasal polyps. Therefore, more research is needed to determine the best targeted therapy for nasal polyps. We found that EGR2 expression was upregulated in CRSwNP patients with allergic rhinitis.In addition, the expression of EGR2 in CRSwNP mucosa was significantly higher than that in the control group, and the expression of EGR2 in CRSwNP with allergic rhinitis was higher than that in CRSwNP without allergic rhinitis. EGR2 may be involved in the pathogenesis of nasal polyps, and may also be related to the severity and recurrence of nasal polyps. EGR2 may be a target for the treatment of nasal polyps.

Eligibility criteria: Inclusion Criteria:

All patients were stopped by systemic or topical corticosteroid treatment at least one month before the study.

Exclusion Criteria:

Patients had NPs accompanied by choanal polyps, fungal nasal sinusitis, cystic fibrosis, acute upper airway upper infection or other systemic diseases.

Primary outcomes:
measure: expression of EGR2
timeFrame: one months
Secondary outcomes:
Other outcomes:
Locations:
city: Zunyi
country: China
facility: Department of Central Laboratory of the Third Affiliated Hospital of ZunYi Medical University
Study officials:
affiliation: Zunyi Medical College
name: Yong Luo, Doctor
role: PRINCIPAL_INVESTIGATOR
References: