louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04491565: An Interactive Video Educational Tool Improves the Quality of Bowel Preparation for Colonoscopy
Official title: An Interactive Video Educational Tool Improves the Quality of Bowel Preparation for Colonoscopy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer Screening
Keywords: colonoscopy
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 270
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The investigators aimed to determine whether an interactive, online educational platform could improve procedure show rates and bowel preparation scores in an outpatient population presenting for routine colonoscopy.

Detailed description: The investigators performed a prospective, endoscopist-blinded, randomized controlled trial at a hospital-based outpatient endoscopy center. Eligible patients were randomized to two groups. Both groups received verbal and written instructions per standard care, while the intervention group received access to an interactive, on-line video. Primary outcomes were bowel preparation scores graded using the Boston Bowel Prep Score (BBPS), procedure show rates, patient satisfaction, and pre-procedure anxiety. Secondary outcomes included adenoma detection rate, mean bowel prep score per colonic segment, total number of polyps detected, and complication rates.

Eligibility criteria: Inclusion Criteria:

* English speaking
* Access to text messaging and the internet (mobile phone access alone was considered sufficient)
* Prescribed standard split-dose bowel preparation
* Able to provide informed consent via telephone.

Exclusion Criteria:

* Pregnant
* Mentally impaired
* Undergoing screening or surveillance for inflammatory bowel disease .

Primary outcomes:
measure: Adequacy of bowel prep
timeFrame: intra procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
References:
Clinical trial NCT03153865: New Therapeutic System of Unruptured Intracranial Aneurysms Based on Big Data From Chinese Population
Official title: New Therapeutic System of Unruptured Intracranial Aneurysms Based on Big Data From Chinese Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Unruptured Cerebral Aneurysm
Treatment Strategy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with unruptured intracranial saccular aneurysm at all age.

Brief summary: This is a prospective, multicenter, observational study, aiming at comparing the Safety and effectiveness among the different surgical treatment of unruptured intracranial aneurysms in China, so as to improve the diagnosis and treatment of unruptured intracranial aneurysms.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with unruptured intracranial saccular aneurysm on CTA, MRA or DSA.
* patients willing to participate in this clinical trial and attach to regular follow up.

Exclusion Criteria:

* intracranial aneurysm correlating to AVM.
* intracranial non-saccular aneurysm.
* the rupture or unrpture of the aneurysm confirmed on CTA、MRA or DSA.
* patients unwilling to participate in this clinical trial and attach to regular follow up.

Primary outcomes:
measure: mortality and disability
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: recurrence rate
timeFrame: 1 month, 6 months and 1 year after surgery;
measure: progression of disease
timeFrame: 1 month, 6 months and 1 year after conservative treatment；
Other outcomes:
measure: the level of psychological states changes
timeFrame: 1 month, 6 months and 1 year after been aware of the disease
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Qinghai Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00777465: Acute Kidney Injury After Cardiac Surgery Based on KDIGO Criteria
Official title: Prognostic Value of Acute Kidney Injury After Cardiac Surgery According to Kidney Disease: Improving Global Outcomes Definition and Staging (KDIGO) Criteria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Keywords: Acute kidney injury
Kidney failure
Risk factors
Clinical outcomes
Cardiac valve surgery
Coronary artery bypass grafting
Morbidity
Mortality
Lead sponsor: Hospital de Base
Sponsor class: OTHER
First posted: 2008-10-22
Enrollment: 2804
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients selected consecutively after cardiac surgery (CABG or CVS) in a setting of postoperative intensive care unit.

Brief summary: The aim of this study was to apply the acute kidney injury criteria based on KDIGO classification in a population of patients undergoing cardiac surgery \[coronary artery bypass grafting (CABG) or cardiac valve surgery (CVS)\] and evaluate its impact as a predictor of 30-day mortality.

Detailed description: This was a single center study. We evaluated retrospectively patients from the Cardiac Surgery Intensive Care Unit in Hospital de Base, São José do Rio Preto Medical School, São Paulo, Brazil. Demographics, type of surgery, laboratory data and preoperative, perioperative, and postoperative information were retrieved from a prospectively collected database of 2878 patients older than 18 years undergoing isolated CABG (1786) or CVS (1092), from January 2003 to June 2013. After applying the exclusion criteria (51 patients with incomplete data and 23 patients with end-stage kidney disease) we analyzed 2804 patients in total, 1738 (62%) underwent CABG and 1066 (38%) underwent CVS.

Eligibility criteria: Inclusion Criteria:

patients undergoing isolated coronary artery bypass grafting or cardiac valve surgery.

Exclusion Criteria:

patients with incomplete data and patients with end-stage kidney disease.

Primary outcomes:
measure: Acute Kidney Injury after cardiac surgery as a independent predictor of 30-day mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: São José do Rio Preto
country: Brazil
facility: Hospital de Base
state: São Paulo
Study officials:
affiliation: São José do Rio Preto Medical School
name: Lilia N Maia, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03491865: Peer-to-peer Tobacco and ENDS Prevention
Official title: Peer-to-peer Social Media Diffusion of Tobacco and ENDS Use Prevention Messages
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Substance Use
Lead sponsor: Real Prevention, LLC
Sponsor class: INDUSTRY
First posted: 2018-04-09
Enrollment: 0
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In Phase I, the REAL media Plus prototype will be developed and a usability test conducted among students and teachers.

In Phase II a group randomized trial will be conducted among 27 high schools to evaluate the effects of REAL media Plus on smoking and vaping.

Detailed description: In Phase I, participants will participate in pilot and usability tests of the curriculum prototype. For the pilot test, teachers and students will use the curriculum prototype and then be interviewed about it. For the usability test, students and teachers will use the revised curriculum and be interviewed/complete short survey. Teachers will provide consent and students will have parental consent and their own assent.

In Phase II, a group randomized trial will be conducted during Spring semester 2020 among 9th grade student in 27 high schools in the Hillsborough County Public School system randomly assigned to treatment and control (14 treatment and 13 control). All students will complete a pretest survey. Students in two health classes in treatments schools will participate in the REAL media Plus curriculum and complete a short immediate posttest survey to rate their experience. All students will then complete two posttests. Students will have parental consent and provide their own assent.

Eligibility criteria: Inclusion Criteria:

Attendance at participating schools; 9th grade student status (for student participants, both phase 1 and 2); status as a teacher/counselor (for phase 1); written parental consent and assent from students (phase 1 and 2); written consent from counselors/teachers (phase 1); and all individuals must be willing to participate.

Exclusion Criteria:

Exclusion criteria include the inability to speak or read American English, use a computer, or navigate the Internet and, for youth, lack of parental consent.

Primary outcomes:
measure: Smoking and Vaping Use
timeFrame: Change in llifetime (e.g., ever tried) use from baseline to 9 months post baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Clifton
country: United States
facility: REAL Prevention LLC
state: New Jersey
Study officials:
affiliation: Real Prevention, LLC
name: Michael Hecht, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01217320: Creatine Supplementation in Pediatric Rheumatology
Official title: Efficacy and Safety of Creatine Supplementation in Patients With Juvenile Systemic Lupus Erythematosus and Juvenile Dermatomyositis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Juvenile Systemic Lupus Erythematosus
Juvenile Dermatomyositis
Keywords: rheumatology
creatine supplementation
quality of life
strength
juvenile systemic lupus erythematosus
juvenile dermatomyositis
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-10-08
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Creatine supplementation may improve strength, muscle mass, bone mass and muscle function in healthy and elderly people. The investigators speculate that creatine supplementation could have therapeutic effects in pediatric rheumatic (i.e., juvenile systemic lupus erythematosus and juvenile dermatomyositis) patients who usually present muscle weakness, muscle wasting and bone mass loss.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with lupus systemic erythematosus and juvenile dermatomyositis
* physically inactive
* stable pharmacological treatment

Exclusion Criteria:

* macroalbuminuria
* GFR \< 30 mL/min/1.73m2
* use of oral anticontraceptive agents
* pregnancy
* diabetes mellitus
* hypothyroidism

Primary outcomes:
measure: muscle strength
timeFrame: after six months
Secondary outcomes:
measure: kidney function parameters
timeFrame: after six months
measure: quality of life
timeFrame: after six months
measure: muscle function
timeFrame: after six months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Bruno Gualano, PhD
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Eloisa Bonfa, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Hayashi AP, Solis MY, Sapienza MT, Otaduy MC, de Sa Pinto AL, Silva CA, Sallum AM, Pereira RM, Gualano B. Efficacy and safety of creatine supplementation in childhood-onset systemic lupus erythematosus: a randomized, double-blind, placebo-controlled, crossover trial. Lupus. 2014 Dec;23(14):1500-11. doi: 10.1177/0961203314546017. Epub 2014 Aug 18.
Clinical trial NCT00285220: Safety and Efficacy of Laparoscopic Truncal Vagotomy for the Treatment of Obesity
Official title: A Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of Laparoscopic Truncal Vagotomy for the Treatment of Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: EndoVx, Inc.
name: University of California, San Francisco
First posted: 2006-02-01
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This two site study will evaluate the safety and effectiveness of laparoscopic truncal vagotomy for the treatment of obesity with baseline study and 18 month post op follow up.

Detailed description: 30 morbidly obese patients evenly enrolled at The University of California San Francisco and at the University of Rochester will be selected for study on a voluntary basis. They will have a BMI of \>35 with at least one obesity related comorbidity or a BMI between 40 and 45. Subjects will undergo specific tests of vagal function and baseline metabolic evaluation at baseline.

Thereafter they will undergo a laparoscopic truncal vagotomy. Over 18 months, post operative tests of adequate vagotomy, weight loss, change in body composition and metabolism will be studied.

Eligibility criteria: Inclusion Criteria:

* male or female age 25-55
* BMI 35-40 with comorbidity and BMI 40-45 with or without comorbidity
* Stable weight for the last 3 months
* willing to use contraceptives
* motivated to lose weight
* a personal history of at least one professionally supervised 6 month attempt or more than 2 serious attempts to loose weight
* fully ambulatory

Exclusion Criteria:

* sign of prior major abdominal surgery
* history of or signs and /or symptoms of gastro-duodenal ulcer disease
* abnormal vagus nerve testing
* current use of a list of medication

Primary outcomes:
measure: Percent Excess Weight Loss
measure: Absolute Weight Loss
measure: Change in BMI
measure: Change in Percent Body Fat (DEXA)
measure: Change in Percent Body Fat (Impedence)
measure: Change in Lipid Panel (chol, triglycerides, LDL, HDL
measure: Urinary pH
measure: 3 day dietary diary
measure: fasting glucose
measure: OGGT with insulin
measure: OGGT with FFA and gut peptides
measure: gastric emptying
Secondary outcomes:
measure: adverse events
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California at San Francisco, Dept of Pediatrics
state: California
city: Rochester
country: United States
facility: Strong Health Bariatric Center at Highland Hospital
state: New York
Study officials:
affiliation: University of California, San Francisco
name: Robert Lustig, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Marco Pattti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rochester
name: Thad Boss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05086874: Using Real-world Evidence to Analyze the Clinical Effects and Adverse Events of Butylphthalide in Stroke Patients
Official title: A Real-world Retrospective Study on the Effectiveness and Safety of Butylphthalide in the Treatment of Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Cerebral Infarction
Brain Infarction
Brain Ischemia
Nervous System Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Keywords: butylphthalide
Ischemic Strokes
Real world research
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 81292
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: Doctors diagnosed with ischemic stroke patients

Brief summary: This is a retrospective, multi-center, real-world study. The researchers plan to include 10,000 cases of ischemic stroke patients using butylphthalide and 10,000 cases of ischemic stroke patients using Edaravone. The main purpose is to analyze the effectiveness and safety of butylphthalide and establish the drug risk assessment management plan.

Detailed description: Ischemic stroke is a type of syndrome in which blood supply to the brain is impaired due to various reasons, leading to local brain tissue ischemia, hypoxic necrosis, and corresponding neurological deficits. It has a high incidence, high morbidity and disability. Features of high recurrence rate.

Butylphthalide can improve the damage of central nervous system in patients with acute ischemic stroke, and can promote the improvement of patients with neurological deficits. Regarding butylphthalide in the treatment of ischemic stroke, there is still a lack of big data research based on the efficacy and safety of the real world.

Therefore, it is planned to include 10,000 patients who used butylphthalide or Edaravone in five hospitals from 2019 to 2021, and record the basic information of the patients, medication status and related test results. The data was cleaned, sorted and analyzed to evaluate the effectiveness and safety of butylphthalide in the treatment of ischemic stroke.

Eligibility criteria: Inclusion Criteria:

* From January 2019 to August 2021, clinicians diagnosed patients with ischemic stroke requiring hospitalization.

Exclusion Criteria:

* Patients who are unable to obtain information such as medical advice, laboratory test results, etc.

Primary outcomes:
measure: The incidence of adverse events
timeFrame: 90days
Secondary outcomes:
measure: NIHSS
timeFrame: 90days
measure: mRS
timeFrame: 90days
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Qianfoshan Hospital
state: Shandong Provincial
Study officials:
affiliation: Qianfoshan Hospital
name: Xin Huang
role: STUDY_DIRECTOR
References:
Clinical trial NCT01318174: Pulmonary Embolism in Exacerbations of Chronic Obstructive Pulmonary Disease
Official title: Prevalence of Pulmonary Embolism in Exacerbations of Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Chronic Obstructive Pulmonary Disease
Keywords: Pulmonary embolism
Pulmonary Disease, Chronic Obstructive
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
First posted: 2011-03-18
Enrollment: 38
Sex: ALL
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: Patients with known or suspected COPD admitted with an exacerbation of unknown aetiology

Brief summary: The purpose of this study is to determine the prevalence of pulmonary embolism in our population of Chronic Obstructive Pulmonary Disease (COPD) patients admitted to hospital with dyspnea. The patients will undergo investigation for pulmonary embolism, according to current guidelines.


Eligibility criteria: Inclusion Criteria:

* known or suspected COPD
* COPD-exacerbation

Exclusion Criteria:

* other causes of dyspnea
* unable to perform CT pulmonary angio (contrast allergy, pregnancy)
* already included in the study (each patient included only once)
* use of anticoagulants

Primary outcomes:
measure: Prevalence of pulmonary embolism in exacerbations of COPD
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Lillehammer
country: Norway
facility: Sykehuset Innlandet
state: Oppland
Study officials:
affiliation: Sykehuset Innlandet HF
name: Aleksander T Holten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06557174: A Study to Evaluate IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients
Official title: A Phase Ib/III Multi-center, Randomized and Positive Control Study to Evaluate IMC-002 Safety and Efficacy in in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Neuromyelitis Optica Spectrum Disorder (NMOSD)
Lead sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 116
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: The purpose of this study is to evaluate the efficacy and safety of IMC-002 in the treatment of NMOSD.

Detailed description: This is a phase Ib/III study, including 2 stage, phase Ib study to find the dose for phase II study between 0.8mg/kg、1.2mg/kg dose level, Phase III study is a multi-center, randomized, double-blind, positive control study to evaluate the safety and efficacy of IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD)

Eligibility criteria: Inclusion Criteria:

* Age 18 to 70 years, inclusive, at the time of informed consent
* Have a diagnosis of AQP4 antibody seropositive NMOSD according to the International Panel for NMO Diagnosis (IPND) criteria
* Confirmation of NMOSD diagnosis with AQP4+ antibodies
* The EDSS score should be ≤7.0
* Have clinical evidence of at least 1 documented attack or relapse (including first attack) in the last 2 years prior to screening

Exclusion Criteria:

* Have received rituximab or other anti-CD20 drugs treatment within 6 months
* Have been used any monoclonal antibodies or research drugs for immunomodulatory effects within 3 months or within 5 half-life periods of the drug.
* Females who are pregnant or lactating.
* Have active infection at screening, or recent serious infection (i.e., requiring intravenous antimicrobial therapy or hospitalization) ; history of or existing infection of human immunodeficiency virus(HIV), hepatitis C virus (HCV), or Mycobacterium tuberculosis. Patients must have negative test results for HCV antibody, HIV 1 and HIV 2 antibodies, and a mycobacterium tuberculosis test (test method to be determined).

Primary outcomes:
measure: Proportion of relapse-free patients
timeFrame: Up to Week 24
Secondary outcomes:
measure: Time to first relapse (TFR)
timeFrame: Up to Week 24
measure: Mean change from baseline in Expanded Disability Status Scale (EDSS) score over the course of the study
timeFrame: Baseline (Day -28 to Day -1) to Week 24
Other outcomes:
Locations:
Study officials:
References: