louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03074708: Application of 3D Visualization and 3D Printing in the Hepatobiliary and Pancreatic Surgery
Official title: Zhujiang Hospital of the Southern Medical University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Diseases
Pancreatic Diseases
Biliary Tract Diseases
Keywords: Three-Dimensional Image
Three Dimensional Printing
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Background:The aim of the study is to value the application of three-dimensional visualization and three-dimensional printing in the hepatobiliary and pancreatic surgery.Method：From January 2016 to December 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D printed model based on the 3D reconstruction model in the operation planning and the operation.The clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery.

Detailed description: From January 2016 to December 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D printed model based on the 3D reconstruction model in the operation planning and the operation.The clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery.

Eligibility criteria: Inclusion Criteria:

* the hepatobiliary and pancreatic diseases

Exclusion Criteria:

* none of the hepatobiliary and pancreatic diseases

Primary outcomes:
measure: operative time
timeFrame: 1 year
Secondary outcomes:
measure: intraoperative blood loss
timeFrame: 1 year
measure: postoperative complications after surgery
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of The Southern Medical University
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital of The Southern Medical University
name: Chihua Fang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03534908: Nonalcoholic Fatty Liver Disease and Cardiovascular Disease: the Correlation Analysis and Risk Prediction Model Study
Official title: Nonalcoholic Fatty Liver Disease and Cardiovascular Disease: the Correlation Analysis and Risk Prediction Model Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: NAFLD
Cardiovascular Diseases
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2018-05-23
Enrollment: 5000000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who have taken medical examination and health checkup in the health management centers of hospitals in China.

Brief summary: Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the world. NAFLD is associated with a lot of comorbidity, such as diabetes, metabolic syndrome, coronary heart disease and chronic kidney diseases. However, the correlation between the NAFLD and cardiovascular disease (CVD) events remains controversial. This study is an observational study based on a big retrospective cohort in china to explore the prevalence of NAFLD in China, the risk factors associated with NAFLD, as well as whether patients with NAFLD are more prone to experience CVDs and CVD events.


Eligibility criteria: Inclusion Criteria:

* males or females aged 18-75

Exclusion Criteria:

* malignancy except primary liver cancer
* pregnancy or breastfeeding
* liver diseases of other etiology including hepatitis C virus infection ,autoimmune hepatitis,Wilson's disease,hemachromatosis,drug-induced hepatitis,parenteral nutrition
* excessive alcohol consumption
* cases missing crucial data

Primary outcomes:
measure: the prevalence of NAFLD in China
timeFrame: June，2020
Secondary outcomes:
measure: the risk factors associated with NAFLD
timeFrame: August，2020
measure: to indicate the prevalence of CVDs and CVD events in people with and without NAFLD
timeFrame: October，2020
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan University
state: Hubei
Study officials:
affiliation: Wuhan University
name: Hongliang Li, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02166008: Cytoprotective Agent and Peptic Ulcer in Dual Antiplatelet :RCT
Official title: Cytoprotective Agent for Peptic Ulcer Prevention in Patients Taking Dual Antiplatelet Agents: A Randomized Double-blind Placebo Control Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Gastric Ulcer Induced by Anti-platelet Agent
Duodenal Ulcer Induced by Anti-platelet Agent
Keywords: Repamipide
Dual antiplatelet
Peptic ulcer
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2014-06-18
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * Primary objective : To evaluate the efficacy of Rapamide in peptic ulcer prevention in patients taking dual antiplatelet agents
* Study Design: Single center, double-blind, randomized-control trial study
* Study drug: Repamipide vs. placebo
* Assessment criteria The patients will be discharged from the study when one of the followings occurred,

  1. Peptic ulcer from upper endoscopy at 3 and 6 month follow up
  2. Clinical of upper gastrointestinal bleeding with peptic ulcer from upper endoscopy
  3. Anemia by CBC at 1,3 ,6,12 month with peptic ulcer from upper endoscopy
  4. Evidence of recurrent myocardial infarction from stent thrombosis


Eligibility criteria: Inclusion Criteria:

1. Age 18-70 year-old
2. Had cardiovascular disease which needed clopidogrel and aspirin
3. Stable enough for gastroscopy

Exclusion Criteria:

1. Gastroscopy revealed peptic ulcer
2. Had contraindication for gastroscopy
3. Not allowed for gastroscopy by cardiologist

Primary outcomes:
measure: number of peptic ulcer by end0scopy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Patumwan
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Bangkok
Study officials:
References:
citation: Pittayanon R, Piyachaturawat P, Rerknimitr R, Prueksapanich P, Chaitongrat S, Lertsuwunseri V, Srimahachota S, Mahachai V. Cytoprotective agent for peptic ulcer prevention in patients taking dual antiplatelet agents: A randomized, double-blind placebo-controlled trial. J Gastroenterol Hepatol. 2019 Sep;34(9):1517-1522. doi: 10.1111/jgh.14671. Epub 2019 May 8.
Clinical trial NCT02264808: Developmental Outcomes
Official title: Clinical Utility of Serum Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy (HIE).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxic-Ischemic Encephalopathy
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2014-10-15
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children 18-20 months of age born with Hypoxic Ischemic Encephalopathy (HIE)

Brief summary: Determine whether the concentrations of UCH-L1 and GFAP measured in umbilical cord blood and in blood 0-6 hours postnatal accurately predict the extent of neurodevelopmental deficits and/or death at 18-20 months.

Detailed description: Children born with Hypoxic Ischemic Encephalopathy (HIE) and already enrolled in IRB #504-2011 will be seen for a developmental follow-up at 18-20 months of age. The developmental assessment tool that will be used is called the Bayley Scales of Infant and Toddler Development: 3rd Edition (Bayley-III) Screening Test. The results of this test will then be compared to the child's HIE biomarkers concentrations already obtained at birth.

Eligibility criteria: Inclusion Criteria:

* children already enrolled in IRB#504-2011
* 18-20 months of age

Exclusion Criteria:

* none

Primary outcomes:
measure: Bayley-III developmental assessment in children, with Hypoxic Ischemic Encephalopathy (HIE) diagnosis at birth, at 18-20 months of age
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Michael D Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05436808: Partial Chest Wall Radiation Therapy After Surgery for Lymph Node Negative Breast Cancer
Official title: Prospective Pilot Study of Partial Chest Wall Radiation Therapy (PCWRT) for Positive or Close Margins After Modified Radical Mastectomy for Lymph Node-Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Breast Cancer Female
DCIS
Stage II Breast Cancer
Stage I Breast Cancer
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The standard treatment for breast cancer when cancer cells were found near or within the margins of the tissue that is removed during breast surgery, is radiation of the entire chest wall. This may be considered overtreatment since the only reason for doing so is that cancer cells were near or in the margins of the breast tissue that was removed. In this study, the amount of radiation treatment will be limited to the area where the remaining cancer cells were found after surgery.

The purpose of this study is to find out if partial chest wall radiation therapy is as good as whole chest wall radiation therapy in reducing the risk of breast cancer cancer coming back.


Eligibility criteria: Inclusion Criteria:

* DCIS or stage T1 or T2 invasive breast cancer, lymph node negative
* Must have undergone mastectomy
* Presence of cancer cells on or close to surgical margins
* Negative pregnancy test for women
* Must receive radiation at Stony Brook University Hospital

Exclusion Criteria

- Received prior radiation to are to be irradiated

Primary outcomes:
measure: Breast cancer recurrence
timeFrame: 5 years
measure: Acute toxicity
timeFrame: 3 months
measure: Delayed toxicity
timeFrame: 5 years
measure: Surgical complications
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: Stony Brook Cancer Center
state: New York
Study officials:
affiliation: Stony Brook University
name: Alexander Stessin, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03204708: Open Technique Interpectoral Catheter for Postoperative Analgesia in Modified Radical Mastectomy
Official title: Evaluation of the Postoperative Analgesic Efficacy of Catheter Placed Interpectoral Region Via Open Technique in Patients Undergoing Modified Radical Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mammary Cancer
Keywords: postoperative analgsia
peripheral block catheter
modified radical mastectomy
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2017-07-02
Enrollment: 86
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: patients undergoing modified radical mastectomy were divided into two groups. patients in catheter group were placed a catheter with open technique by the surgeon in the pectoral area. thirty minutes before extubation %1 lidocain 10 ml, %0.5 bupivacain 10 ml and 10 ml %0.9 sodium chloride were given through the catheter for postoperative analgesia. patients in iv analgesia group were given 100 mg tramadol iv 30 minutes before extubation. visual analog pain scale (VAS) scores, rescue analgesic requirement, complications were recorded and compared between two groups 1, 6, 12, 24 hours and 90 days after surgery.

Detailed description: patients undergoing modified radical mastectomy were divided into two groups by computer. patients in catheter group were placed a catheter under clavipectoral fascia in the neighbourhood of nervus thoracicus longus, nervus thoracodorsalis, nervus pectoralis lateralis, nervus pectoralis medialis at the 1/3 lateral part of clavicula. solution included 10 ml of %0.5 bupivacain, %1 lidocain, 10 ml %0.9 sodium chloride totally 30 ml were given via the catheter for postoperative analgesia at the end of surgery. patients in iv analgesia group were given 100 mg tramadol iv 30 minutes before extubation. Patients in both groups were given dexketoprofen 50 mg iv if the VAS score was over 4. VAS scores, rescue analgesic requirement and timing, complications were recorded and compared between groups 1, 6, 12, 24 hours and 90 days after surgery.

Eligibility criteria: Inclusion Criteria:

* American Society of Americans Class I-II

Exclusion Criteria:

* male
* allergy to local anesthetics or
* anticoagulant drug use
* central or peripheric nerve disease
* pregnancy

Primary outcomes:
measure: VAS scores
timeFrame: 1 hour after operation
measure: VAS scores
timeFrame: 6 hours after operation
measure: VAS scores
timeFrame: 12 hours after operation
measure: VAS scores
timeFrame: 24 hours after operation
Secondary outcomes:
measure: VAS scores
timeFrame: 3 months after operation
Other outcomes:
measure: rescue analgesic requirement
timeFrame: 1, 6, 12 and 24 hours after operation
Locations:
Study officials:
affiliation: Istanbul University
name: cigdem akyol beyoglu, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06684808: Impact of Active Breaks in Elementary School Children
Official title: Impact of Active Breaks in the Classroom on Physical, Mathematical and Cognitive Performance in Elementary School Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Performance
Cognitive Performance
Academic Acheivement
Keywords: active breaks
children
academic achievement
physical activity
school time
Lead sponsor: University of Molise
Sponsor class: OTHER
Collaborators: name: Alessandra di Cagno
name: Giuseppe Calcagno
name: Giovanni Fiorilli
name: Andrea Buonsenso
First posted: 2024-11-12
Enrollment: 159
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study was to evaluate the effects of 12 weeks of Active Breaks on motor, academic and cognitive performance in elementary school children.

Detailed description: The purpose of the study was to evaluate the effects of 12 weeks of Active Breaks on motor, academic and cognitive performance in elementary school children. 159 children were recruited: 92 for experimental group (EG) and 67 for Control Group(CG); after the baseline assessment, the EG classes were randomly assigned into three experimental groups: creativity AB (CREAT; n = 30 ), fitness AB (FIT; n =31 ) and combined AB (COM; n= 31 ) . Specifically, the EG carried out an active break intervention for 12 weeks during curricular time, repeated twice a day, with the duration of 10 minutes, three times a week. CG did not performed any type of active breaks.

Eligibility criteria: Inclusion Criteria:

* attending second and third elementary classroom

Exclusion Criteria:

* to be free from injury, which could preclude the PA practice.

Primary outcomes:
measure: Height
timeFrame: after 12 weeks
measure: Weight
timeFrame: after 12 weeks
measure: Leaps forward on one foot
timeFrame: after 12 weeks
measure: Side Gallop
timeFrame: after 12 weeks
measure: Alternating forward hops on one foot
timeFrame: after 12 weeks
measure: Throwing a ball with one hand
timeFrame: after 12 weeks
measure: Receiving with the hands a thrown ball
timeFrame: after 12 weeks
measure: Hitting the ball with a tennis racket
timeFrame: after 12 weeks
measure: Long jump from a standing start
timeFrame: after 12 weeks
measure: Fast shuttle run 10x5m
timeFrame: after 12 weeks
measure: Assessment Test of Calculation Skills AC.MT 6-11
timeFrame: after 12 weeks
measure: Reynolds Interference Task (RIT) test
timeFrame: after 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Campobasso
country: Italy
facility: Università degli Studi del Molise
state: CB
Study officials:
References:
Clinical trial NCT01965808: A Study of LY2157299 in Healthy Participants
Official title: Effect of Food on the Pharmacokinetics of LY2157299 Monohydrate in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-10-18
Enrollment: 16
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Participants in this study will receive two oral doses of 150 milligram (mg) LY2157299 taken at least 4 days apart. One dose will be given without food. One dose will be given with a high fat meal. The study will evaluate the effect of a high fat meal on how much of the drug gets into the blood stream. Side effects will be documented. This study will last approximately 15 days not including screening. Screening is required within 30 days prior to the start of the study.


Eligibility criteria: Inclusion Criteria:

* Healthy sterile males or females
* Are able to eat a high fat meal
* No abnormal heart function or high blood pressure
* No participation in a clinical trial within 30 days
* No evidence of human deficiency virus (HIV), hepatitis C or hepatitis B

Exclusion Criteria:

* Have a clinically significant abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study

Primary outcomes:
measure: Pharmacokinetics: Maximum Concentration (Cmax) of LY2157299
timeFrame: Pre-dose through 72 hours post-dose in each study period
measure: Pharmacokinetics: Time of Maximum Observed Concentration (tmax) of LY2157299
timeFrame: Pre-dose through 72 hours post-dose in each study period
measure: Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2157299
timeFrame: Pre-dose through 72 hours post-dose in each study period
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
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.
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01538108: Study of NMB (Company's Name) Drug Ejecting Balloon for Arteriovenous Fistulae
Official title: The Use of NMB Drug Ejecting Balloon for Arteriovenous (AV) Dialysis Fistulae
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Lesions of Arteriovenous Dialysis Fistulae
Lead sponsor: N.M.B. Medical Applications Ltd
Sponsor class: INDUSTRY
First posted: 2012-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the safety and effectiveness of the use of NMB's percutaneous transluminal angioplasty (PTA) Balloon.


Eligibility criteria: Inclusion Criteria:

* patients 18 years and older
* Patients with arteriovenous fistula with obstructive lesion
* Patient who is willing and able to sign a written informed consent

Exclusion Criteria:

* age \< 18
* female with child bearing potential
* Previous participation in another study with any investigational drug or device within the past 30 days
* Life expectancy of less than 12 months

Primary outcomes:
measure: Restenosis Rate
timeFrame: 6 months
Secondary outcomes:
measure: Restenosis rate
timeFrame: 1,3 and 12 months
measure: Easy insertion and removal
timeFrame: intraprocedural
measure: Major adverse events
timeFrame: intraprocedural, 1, 3, 6 and 12 months
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
Study officials:
References:
Clinical trial NCT05380908: Brain Metabolic Network of PET in Patients With Advanced Non-Small Cell Lung Cancer
Official title: The Fifth Affiliated Hospital of Sun Yat-sen University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Non-small-cell Lung Cancer
Lead sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pathological confirmed non-small cell lung cancer

Brief summary: This study is a retrospective study, screening patients with systemic PET / CT scan in our department, enrolling the ones who meet the criteria, collect their information and resting state brain PET images.Then make the brain metabolic network analysis and statistical analysis to explore the PET brain metabolic network of non-small cell lung cancer patients and the effect of chemotherapy drugs on brain metabolic network in patients with advanced lung cancer.

Detailed description: 1. Enroll Participants
2. Collect PET/CT Images
3. Images Analysis
4. Statistical Analysis

Eligibility criteria: Inclusion Criteria:

* Patients with advanced non-small cell lung cancer without any treatment and pathological confirmed non-small cell lung cancer.

Exclusion Criteria:

* Brain tumors (primary or metastasis), previous surgery, radiotherapy, chemotherapy, stroke, head trauma, psychiatric history (insomnia, depression, mania, schizophrenia and other psychiatric disorders), or history of drug dependence (e. g. sedatives, sleeping pills or sedatives)

Primary outcomes:
measure: Death
timeFrame: 1-5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: PET/CT
state: Guangdong
Study officials:
References: