louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03011879: China STEMI Care Project Phase 2
Official title: China STEMI Care Project Phase 2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ST-Elevation Myocardial Infarction
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Medical Doctor Association
First posted: 2017-01-05
Enrollment: 18000
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: STEMI patients with symptom onset within 30 days

Brief summary: The program is to improve STEMI medical care quality in China. With the documents issued by National Health and Family Planning Commission of the People's Republic of China, the program was initialed in at least 200 primary PCI capable hospitals together with hundreds of adjacent non-primary PCI capable hospitals in 15 provinces. STEMI patients with symptom onset within 30 days will be enrolled in 3 periods. In each period with 6-month interval, 30 patients will be enrolled consecutively from each PCI-capable center initially and from non-primary PCI capable hospitals later, thus at least 18,000 STEMI patients from primary PCI capable hospitals will be enrolled and all of them will be followed up for 1 year. Key performance indicators (KPIs) in STEMI care will be collected using both national PCI online registry and a program STEMI online registry database for the purpose of improvement of medical care. Hospital KPIs rank report and problem-based resolution will be feedback to each hospital after data analysis in each period. Comparison of every two cross-sectional data (self) and within one cross-sectional (inter-hospital) data will be used to evaluate the improvement of medical quality.


Eligibility criteria: Inclusion Criteria:

* STEMI patients with symptom onset within 30 days

Exclusion Criteria:

* None

Primary outcomes:
measure: Referfusion ratio in patients with symptom onset within 12 hours
timeFrame: 12 hours
measure: Door-to-ballnoon time in patients with symptom onset within 12 hours
timeFrame: 12 hours
measure: Door-to-needle time in patients with symptom onset within 12 hours
timeFrame: 12 hours
measure: Hospital admission via ambulance ratio
timeFrame: 2 years
measure: Symptom onset to arrive in hospital
timeFrame: 2 years
measure: Bypass ED ratio in patients with symptom onset within 12 hours
timeFrame: 12 hours
measure: Usage of both DAPT, statin, β blocker and ACEI/ARB in patients without contraindication
timeFrame: 3 yeras
measure: In-hospital morbidity
timeFrame: 2 yeras
measure: 1-year on time follow-up ratio
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Cardiology, Peking University First Hospital
Study officials:
References:
Clinical trial NCT02017379: Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed.
Official title: Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Upper Gastrointestinal Bleeding
Keywords: upper gastrointestinal bleeding
melena
hematemesis
Lead sponsor: Texas Tech University Health Sciences Center, El Paso
Sponsor class: OTHER
First posted: 2013-12-20
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This is a study comparing the effect of erythromycin or metoclopramide, 2 prokinetic drugs (Drugs which are known to speed up the emptying of the stomach or in other words to move the blood out of the stomach faster) given before endoscopy to patients with upper Gastrointestinal bleeding compared to patients who will not receive either of these medications before their endoscopy.

Detailed description: To compare the efficacy of pre-endoscopic interventions namely erythromycin, metoclopromide vs control in improving the outcomes of endoscopy in ICU patients admitted upper GI bleeding.

Specific aims:

1. Wither erythromycin, metoclopromide vs control can enable visualization of the entire gastric mucosa .
2. Wither erythromycin, metoclopromide vs control can improve the quality of stomach and duodenum visualization: using the scoring system by Fossard et al

Eligibility criteria: Inclusion Criteria:

* Adult patients (18-80)
* who are admitted to the ICU for hematemesis, or coffee ground emesis

Exclusion Criteria:

1. Patients younger than 18 yrs old or older than 80 yrs
2. Patients who refuse to consent to be in our study
3. Pregnant patients
4. Prior use of prokinetics in the last 48 hours
5. History of cardiac arrhythmia
6. Allergy to erythromycin or metoclopromide
7. Patients with QT prolongation (query 7)

   -

Primary outcomes:
measure: Erythromycin, Metoclopromide vs Control Enabling Visualization of the Entire Gastric Mucosa .
timeFrame: 45 minutes
measure: Erythromycin, Metoclopromide vs Control Improving the Quality of Stomach and Duodenum Visualization
timeFrame: 45 minutes
Secondary outcomes:
measure: Source of Bleeding
timeFrame: 45 minutes
measure: Second-look Endoscopy
timeFrame: 48 hours
measure: Blood Units Transfused
timeFrame: 48 hours
measure: Mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: El Paso
country: United States
facility: Texas Tech University Health Science Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Mohamed O Othman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03581279: Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel
Official title: Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lyme Disease
Lead sponsor: T2 Biosystems
Sponsor class: INDUSTRY
First posted: 2018-07-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The T2Lyme assay will be compared to Borrelia culture from erythema migrans (EM) biopsy and/or detection of the C6 antigen in serum collected prospectively from patients suspected of early Lyme disease.

Detailed description: The objective of this study is to demonstrate the clinical performance of the T2Lyme Panel on the T2Dx instrument. The assay will be compared to Borrelia culture from erythema migrans (EM) biopsy and/or detection of the C6 antigen in serum collected prospectively from patients suspected of early Lyme disease. The data from this study will be used to support a de novo application for the T2Lyme Panel to the U.S. Food and Drug Administration (FDA) for product approval.

The T2Lyme Panel is an investigational use in vitro diagnostic (IVD) designed to qualitatively detect and identify the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as an inclusive Borrelia spp. detection channel) from K2EDTA human whole blood samples.

Eligibility criteria: Inclusion Criteria:

* Presence of erythematous skin lesion, consistent with erythema migrans (EM).
* Age 18 or older.
* Ability to read, comprehend, and sign the informed consent form.
* Two (2) or more signs/symptoms of Lyme Disease

Exclusion Criteria:

* Subject has medically diagnosed bleeding disorder.
* Having had taken antibiotics in the past 30 days.
* EM located on face or neck.
* Unable to provide consent.

Primary outcomes:
measure: Number of Participants With Lyme Disease Detected in Human Whole Blood Samples
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Wakefield
country: United States
facility: South County Internal Medicine
state: Rhode Island
city: La Crosse
country: United States
facility: Gundersen Health System
state: Wisconsin
Study officials:
References:
Clinical trial NCT01446679: Special Drug Use-Results Survey of Lipitor Tablets
Official title: Special Drug Use-Results Survey of Lipitor Tablets
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Keywords: Lipitor
HMG-CoA reductase inhibitor
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-10-05
Enrollment: 24050
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: Patients with hypercholesterolemia who have not achieved the category-specific target lipid level in other statin therapies

Brief summary: This study is to evaluate the controlling effect of atrovastatin on plasma lipid to achieve the category-specific targeted lipid levels.

Detailed description: To confirm the low-density lipoprotein cholesterol (LDL-C)-lowering effect of 24 weeks of treatment with Lipitor®(Generic Name : atorvastatin calcium) Tablets and determine the rate of achievement of the category-specific target LDL-C level in patients with hypercholesterolemia; and to confirm the usefulness (efficacy and safety) of atorvastatin in patients who have not responded sufficiently to other statin therapies

Eligibility criteria: Patients with hypercholesterolemia who have not achieved the category-specific target lipid level

Primary outcomes:
measure: Changes in plasma LDL-C concentration
timeFrame: 0, 4, 12 and 24 week
measure: Change in rate of achievement of the category-specific target LDL-C level
timeFrame: 0, 4, 12 and 24 week
Secondary outcomes:
measure: Change in plasma lipid values (LDL cholesterol, HDL cholesterol, triglycerides, total cholesterol, and malondialdehyde-modified LDL [MDL-LDL])
timeFrame: 0, 4, 12 and 24 week
measure: Changes in renal function test values (urinary albumin, urinary creatinine, urinary protein, and serum creatinine)
timeFrame: 0, 4, 12 and 24 week
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyushu
country: Japan
city: Shikoku
country: Japan
city: Touhoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contract
role: STUDY_CHAIR
References:
Clinical trial NCT05992779: Cochlear Implantation in the Elderly
Official title: RELEVANCE OF COCHLEAR IMPLANTATION IN THE VERY ELDERLY: LENGTH OF DURATION AND OUTCOMES
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cochlear
Implant
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 150
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 80 years or more

Brief summary: The goal of this study is to demonstrate that cochlear implantation is an effective, reasonable, and viable long-term option within a very elderly population


Eligibility criteria: * Inclusion Criteria :

  * 80 years or more
  * Primo-implantation
* Exclusion Criteria :

  * Under 80 years
  * Bilateralisation
  * Explantation or re-implantation

Primary outcomes:
measure: Vocal audiometry
timeFrame: Through study completion, an average of 1 year
measure: Data Loging
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot
Study officials:
References:
Clinical trial NCT03240679: Endoscopic Mucosal Resection and Cellular Matrix
Official title: A Randomized Study of Biologic Scaffolds And Esophageal Healing Following Endoscopic Resection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Barretts Esophagus With High Grade Dysplasia
Barrett Adenocarcinoma
Keywords: Barrett's esophagus
Endoscopic Mucosal Resection
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot study 10 in each group
Primary purpose: PREVENTION

Brief summary: This study is being done to test the usefulness of extracellular matrix (ECM) a thin sheet placed over the site after endoscopic mucosal resection to promote healing of the esophagus.


Eligibility criteria: Inclusion Criteria

* Able to provide consent
* Scheduled for standard of care endoscopy that may require initial EMR evaluation of esophageal lesions
* Histological evidence of intestinal metaplasia with dysplasia or intramucosal carcinoma

Exclusion Criteria

* Pregnant women
* Prior esophageal EMR or ESD in the same region
* Anyone unable to provide informed consent
* Medical co-morbidities precluding EGD evaluation
* History of chemoradiotherapy to the neck/esophagus
* Unable to stop anticoagulation therapy (non-steroid anti-inflammatory medications are permissible)

Primary outcomes:
measure: Completeness of EMR Site Healing at Follow up Endoscopy
timeFrame: approximately 3-4 months post EMR
Secondary outcomes:
measure: Presence of Stricture Formation at Follow up Endoscopy
timeFrame: approximately 3-4 months post EMR
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kenneth K Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04900779: Evaluation of Glycocalyx in Major Abdominal and Thoracic Surgery
Official title: Prospective Observational Study to Evaluate Glycocalyx Alteration in Major Abdominal and Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Major Elective Abdominal and Thoracic Surgery
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 117
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 older than 18 years old that undergo major abdominal and thoracic elective surgery in University Hospital Vall d´Hebron.

Brief summary: Background:

The glycocalyx is a fundamental component of the endothelial barrier and alterations at this level have been shown to exacerbate the inflammatory response in the microcirculation. Its degradation in the surgical patient, has been tested in interventions that involve regional or general ischemia, for example in cardiac surgery, major vascular surgery or transplantation. On interventions that do not involve ischemic events the literature is limited, such is the case of those patients undergoing major abdominal and thoracic surgery.

Objective:

Assess whether there is a glycocalyx degradation in major elective abdominal and thoracic surgery, measured as an increase in plasma syndecane-1 levels during the first 24 hours of postoperative care.

Methodology:

Prospective observational study in patients undergoing major elective thoracic and abdominal surgery at the University Hospital Vall d´Hebrón. Measurement of the syndecane-1 plasma levels are going to be done during the first 24 hours after the intervention. It is intended to evaluate whether its elevation is related to anesthetic perioperative factors, and if it has an impact con morbildity and mortality in the following 6 months after the procedure.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old
* Patients that are scheduled to major abdominal and thoracic elective surgery in Universtity Hospital Vall d´ Hebrón.
* Patients ASA I, II and III.
* Patients that after the intervention have their recovering in the Surgical ICU

Exclusion Criteria:

* Patients ASA IV and V.
* Patients that are hospitilized previous to the surgery.
* Patients that undergo emergent surgery.
* Patients with Chronic or Acute Renal Failure previous to the surgery.
* Patients with past medical history of autoinmune disseases.
* Patients with an active infection previous to the surgery.
* Patients in treatment with steroids previous to the surgery

Primary outcomes:
measure: plasmatic syndecan -1 levels
timeFrame: In the first 24 hours after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d´Hebron
Study officials:
References:
Clinical trial NCT03884179: Diagnosis of PCL With EUS-FNA and Cross-sectional Imaging - A Report of Accuracy
Official title: Diagnosis of Pancreatic Cystic Lesions With EUS-FNA and Cross-sectional Imaging - A Report of Accuracy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cyst
Pancreatic Neuroendocrine Carcinoma
Pancreatic Pseudocyst
Pancreatic Serous Cystadenoma
Pancreatic Mucinous Cystadenoma
Pancreatic Cystadenocarcinoma
Pancreatic Intraductal Papillary-Mucinous Neoplasm
Solid Pseudopapillary Tumor of the Pancreas
Keywords: Endoscopic ultrasound
Radiology
Accuracy
Pancreatic Cyst
Pancreatic Cystadenocarcinoma
Pancreatic Mucinous Cystadenoma
Pancreatic Intraductal Papillary-Mucinous Neoplasm
Pancreatic Serous Cystadenoma
Pancreatic Pseudocyst
Pancreatic Neuroendocrine Tumor
Solid Pseudopapillary Tumor of the Pancreas
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with suspected PCLs according to radiology undergoing evaluation with EUS-FNA at a tertiarry endoscopy center from February 2007 until March 2017. The catchemnt area of this cente has a population of about two million.

Brief summary: Pancreatic cystic lesions (PCLs) comprise of a heterogeneous group of entities that are benign, premalignant or malignant. With increased use of modern imaging techniques in recent years, incidentally discovered PCL have become much more common. However, imaging modalities for characterising PCL is a known clinical uncertainty since imaging is capable of detecting these lesions but may often not be able to distinguish malignant from benign lesions. Incorrect assessment of PCL can lead to fatal consequences because a malignant lesion may not be treated and a benign may be unnecessarily resected. The aim of this study was to assess the performance of endoscopic ultrasound with fine-needle aspiration (EUS-FNA) in the diagnosis of pancreatic cystic lesions compared to cross-sectional imaging modalities (CT/MRI). Our hypothesis is that EUS-FNA has a higher accuracy for diagnosing PCLs compared with cross-sectional imaging.


Eligibility criteria: Inclusion Criteria:

Patients with suspected PCLs according to radiology undergoing evaluation with EUS-FNA at a tertiarry endoscopy center from February 2007 until March 2017, who underwent pancreas resection

Oral and written consent of patients examined

Exclusion Criteria:

None

Primary outcomes:
measure: Accuracy of EUS-FNA vs Radiology
timeFrame: 10 years
Secondary outcomes:
measure: Accuracy of EUS-FNA vs morphology
timeFrame: 10 years
measure: Accuracy of EUS FNA vs cytology
timeFrame: 10 years
measure: Accuracy of EUS FNA vs CEA
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05214079: Determination of the Left Paratrachéal Force Required to Occlude the Esophageal Entrance
Official title: Determination of the Left Paratrachéal Force Required to Occlude the Esophageal Entrance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oesophageal Reflux
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Determine the force required to occlude the esophagus with a left paratracheal pressure


Eligibility criteria: Inclusion Criteria:

* Physical status score 1 or 2
* No contre indication to Left Paratracheal pressure

Exclusion Criteria:

* Obese patients
* Physical status score 3, 4 or 5
* Contre indication to Left Paratracheal pressure

Primary outcomes:
measure: Necessary force of Left paratracheal pressure to occlude the esophagus in female versus male . an up and down method will define the CP 50 in each gender. A comparison between CP50 in both sex will define exactly our outcome
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00508079: Evaluating the Occurence of New and Progression of Existing Peripheral Venous Disease in Leg Veins
Official title: Incidence and Progression of Peripheral Venous Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Vascular Diseases
Keywords: Venous Disease
Varicose Veins
Chronic Venous Insufficiency
PAD
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2007-07-27
Enrollment: 1103
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previous participants from the San Diego Population Study

Brief summary: Peripheral venous disease occurs when a vein becomes damaged or blocked. It can occur almost anywhere in the body, but is most common in the arms and legs. This study will examine people who participated in a previous venous disease study to evaluate changes in leg veins and venous disease status over a period of 11 years.

Detailed description: Peripheral venous disease is a general term for damage, defects, or blockage that occurs in the peripheral veins, which carry blood from the hands and feet back to the heart to receive oxygen. The most common cause of peripheral venous disease is a blood clot that blocks a vein. Varicose veins, which are swollen blood vessels near the surface of the skin, and chronic venous insufficiency, a condition in which blood in the leg veins does not drain properly, are two other common types of peripheral venous disease. From 1996 to 2000, the San Diego Population Study (SDPS) evaluated a group of individuals to gather information on the prevalence of venous disease. This current study will re-evaluate the SDPS participants to document changes that have occurred in their leg veins over the past 11 years, including any new venous disease and any progression of existing venous disease. Study researchers will also evaluate how venous disease relates to risk factors, symptoms, and quality of life issues.

This study will enroll people who participated in the SDPS study. Each participant will attend one study visit. Study staff will conduct a 1-hour interview with each participant to collect information on their medical history, disease-related symptoms, risk factors for venous disease, family health history, health habits, and quality of life. Blood collection will occur, participant's leg veins will be examined and photographed, and blood flow in the legs will be measured with an ultrasound.

Eligibility criteria: Inclusion Criteria:

* Participated in the SDPS study

Primary outcomes:
measure: Incident Venous Disease
timeFrame: Since previous visit (approximately 11 years)
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Michael H. Criqui, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: