louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04241146: Optimal Feeding Tube Placement
Official title: A Randomized Controlled Trial for Optimal Feeding Tube Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteral Feeding Intolerance
Keywords: enteral nutrition
radiation exposure
nursing care
pediatrics
radiation, non-ionizing
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Avanos Medical
First posted: 2020-01-27
Enrollment: 52
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial comparing current standard blind method to CORTRAK enteral access system (CEAS), an FDA approved electromagnetic device to place enteric tubes.

Detailed description: Patient population would include patients in pediatric intensive care unit, pediatric cardiac unit, intermediate medical care unit and pediatric floor who receives postpyloric feeding tube placements. The study team are going to monitor total time and number attempts required for each successful placement, correlation of findings on x-ray versus CEAS, cost-effectiveness of this new equipment with standard blind method and decrease in radiation exposure with CEAS.

Eligibility criteria: Inclusion Criteria: Patient admitted to pediatric floor, intermediate care unit, pediatric intensive care unit, or congenital care unit requiring post-pyloric feeding tube placement of size eight french or more and not meeting any of exclusion criteria

Exclusion Criteria: Under three kilograms, Open chest wall, Open abdominal wall

Primary outcomes:
measure: Duration of Time
timeFrame: Baseline to End of procedure up to 30 minutes
Secondary outcomes:
measure: Number of X-Rays
timeFrame: Baseline to End of procedure up to 30 minutes
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University Hospital
state: Texas
Study officials:
affiliation: University of Texas Health San Antonio
name: Andrew Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jha P, Rupp L, Bonilla L, Gelfond J, Shah JN, Meyer AD. Electromagnetic Versus Blind Guidance of a Postpyloric Feeding Tube in Critically Ill Children. Pediatrics. 2020 Oct;146(4):e20193773. doi: 10.1542/peds.2019-3773.
Clinical trial NCT00192946: The CRT-KIR Study (Cardiac Resynchronization Therapy [CRT] in the Early Phase After Heart Surgery)
Official title: Cardiac Resynchronization Therapy (CRT) in the Early Phase After Heart Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bundle-Branch Block
Keywords: Cardiac resynchronization
Heart failure
open heart surgery
surgery
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2005-09-19
Enrollment: 60
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: In patients with broad QRS complexes on electrocardiogram (ECG), the delayed electrical activation of the left heart chamber will cause abnormal contraction.This has been shown to be possible to treat by a special pacemaker treatment which includes pacing of the left heart chamber (= CRT treatment).

In this study the researchers will investigate the effect of acute CRT treatment in the early phase after open heart surgery.

Detailed description: Patients with bundle branch block have a delayed electrical activation of the left ventricle causing abnormal contractility of the left ventricle.

We hypothesize that patients may benefit from short term (= 72 hours) CRT (Cardiac Resynchronization Therapy) in the early phase after open heart surgery.

Patients: reduced LV function and bundle branch block.

Study type: randomisation to CRT versus standard postoperative treatment

Study variables: cardiac output, echocardiographic measures, p-BNP and hours with inotropic therapy.

Eligibility criteria: Inclusion Criteria:

* Patient scheduled for open heart surgery (coronary artery bypass graft \[CABG\] or mitral valve surgery or aortic valve surgery or combinations of the above mentioned surgical procedures) and LV ejection fraction \< 35% and bundle branch block (QRS \> 9.12 s)

Exclusion Criteria:

* Severe right heart failure
* Permanent atrial fibrillation
* Congenital heart disease
* Serious non-cardiac disease

Primary outcomes:
measure: Non invasive cardiac output after 72 hours CRT (versus control) treatment
Secondary outcomes:
measure: Echocardiographic measures of left ventricular (LV) function
measure: Mixed venous oxygen saturation
measure: Invasively determined cardiac output
measure: Plasma brain natriuretic peptide (p-BNP)
measure: Number of hours with inotropic treatment
Other outcomes:
Locations:
Study officials:
affiliation: Rigshospitalet, Denmark
name: Jesper H Svendsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04541446: Study Dynamic Haptic Robotic Trainer (DHRT) and DHRT+ for CVC Insertion Training for Surgical Residents
Official title: Study Dynamic Haptic Robotic Trainer (DHRT) and DHRT+ for CVC Insertion Training for Surgical Residents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Central Line Complication
Central Line Infection
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-09-09
Enrollment: 625
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: Human participants will include medical residents and patients. Each year the entering 1st year medical residents at Hershey Medical Center and Cedars-Sinai Medical Center will be taught to perform these procedures using the DHRT or the DHRT+ devices. The resident's performance will be measured and evaluated by these devices during the training. The technique of the training does not differ from what is currently taught at either of these institutions. In addition the residents will be required to pass the same skills assessment currently required at their institution. Upon successfully passing the skills assessment the residents will perform CVC interventions on under supervision. During this supervision the attending will fill out a short survey about the residents performance. After the procedure the investigators will examine patient files to determine any changes in central line related complications and infection rates due to new clinical educational practices.


Eligibility criteria: Inclusion Criteria:

* patient undergoing central venous catheterization

Exclusion criteria:

* patient that is not undergoing central venous catheterization

Primary outcomes:
measure: Change in Central Line Related Complications due to new Resident Central Line Training Procedures
timeFrame: baseline (pre-intervention), post-intervention
measure: Change in Central Line Related Infections due to new Resident Central Line Training Procedures
timeFrame: baseline (pre-intervention), post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Hershey
country: United States
facility: Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Scarlett R Miller, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University
name: Jason Z. Moore, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02101346: A Human In Vivo Feeding Study Of The Blood Monocyte Response To Dietary Lipid Intake
Official title: A Human In Vivo Feeding Study Of The Blood Monocyte Response To Dietary Lipid Intake
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atherosclerosis
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the present study is to identify the effects of different dietary fats on the body's immune system and how different types of cells respond. There will be two rounds of recruitment in order to satisfy different aims of the study. In the first round, volunteers will be asked to undergo five separate 1-day assessments where you will be given diets in the form of milkshakes differing in amounts of fats. Volunteers recruited for this round will also be given the opportunity to participate in the second round of recruitment and feeding. A second round of recruitment will then take place to complete recruitment, if required. In the second round, volunteers will be asked to undergo two separate 1-day assessments in the form of milkshakes with differing fats, one of which will contain a tracking label added to the food during preparation. This label is in the form of is a 'stable isotope' and safe to consume (used commonly in some medical tests - see below for further information) and will allow the researchers to later find the food particles within blood cells. During these 1-day assessments blood samples will be collected to identify the impact different diets have on the immune system, specifically monocyte cells thought to play an important role in the development of atherosclerosis, a primary cause of cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

* healthy men
* aged between 18-65 years (inclusive)
* body mass index of between 18.5-25kg/m2

Exclusion Criteria:

* Female
* Undiagnosed metabolic syndrome (assessed at initial screening)
* Current smokers
* Substance abuse
* Excess alcohol intake
* Significant medical illness including: diabetes, established cardiovascular disease, cancer, gastrointestinal disease (e.g. inflammatory bowel disease or irritable bowel syndrome), kidney, liver or pancreatic disease or autoimmune or inflammatory disease processes.
* Taking regular medications
* Major surgery in last 6 months

Primary outcomes:
measure: Change in ICAM-1 expression by monocytes
timeFrame: 3 years
Secondary outcomes:
measure: Intracellular lipid volume
timeFrame: 3 years
measure: Quantity of dietary fatty acid within postprandial monocytes
timeFrame: 3 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College
Study officials:
affiliation: Imperial College London
name: Kevin J Woollard, BSc MSc PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05723146: Spatial Cognition Assessment in Virtual Reality
Official title: Spatial Cognition Assessment in Virtual Reality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spatial Neglect
Keywords: spatial neglect
virtual reality
assessment
Lead sponsor: Université Paris Cité
Sponsor class: OTHER
Collaborators: name: Hopitaux de Saint-Maurice
name: Université Paris-Saclay
First posted: 2023-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 60 patients with right stroke will be included in this study: a group of 30 patients with USN will be compared to a group of 30 patients without USN.
Primary purpose: SCREENING

Brief summary: Unilateral spatial neglect (USN) is a highly-prevalent neuropsychological syndrome following a cerebral stroke characterized by massive impairments in daily life. The evaluation and the rehabilitation of USN encounter many limits whereas immersive virtual reality (VR) could be an efficient tool to go through these limits by imitating an environment of perception and action very close to the real one. The investigators will test a multisensory battery of evaluation based on VR for the diagnostic of USN.


Eligibility criteria: Inclusion Criteria:

* unilateral right stroke

Exclusion Criteria:

* epilepsy / migraine
* craniotomy
* major sensory/motor deficit
* severe cognitive impairment

Primary outcomes:
measure: Omissions in cancellation tasks
timeFrame: Baseline
measure: Deviation in line bisection tasks
timeFrame: Baseline
measure: Number of the cubes in each side of space in the Baking Tray Tasks
timeFrame: Baseline
measure: Detections in the localization tasks
timeFrame: Baseline
Secondary outcomes:
measure: Duration of eye fixation in each side of space during VR tasks
timeFrame: Baseline
measure: Completion time of each task
timeFrame: Baseline
measure: Score in the Catherine Bergego Scale (CBS)
timeFrame: Assessed within the same week as Baseline
Other outcomes:
Locations:
city: Paris
country: France
facility: Université Paris Cité
Study officials:
References:
Clinical trial NCT01843946: Clinical Efficacy of Roxithromycin in Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Prostatitis
Chronic Pelvic Pain Syndrome
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2013-05-01
Enrollment: 75
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 75

Brief summary: Roxithromycin is effective in the treatment of intracellular organisms, including chlamydia and mycoplasma, and exhibits anti-inflammatory and immunomodulatory effects on respiratory diseases. To explore the potential therapeutic benefit of roxithromycin in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), this study compared the effect of roxithromycin with ciprofloxacin and aceclofenac.

Detailed description: A total of 75 patients with CP/CPPS were randomized to three groups in open-label: group 1, ciprofloxacin; group 2, aceclofenac; and group 3, roxithromycin. The patients were treated for 4 weeks and were subsequently followed for 12 weeks. Changes from baseline in the total and domain scores of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) were evaluated.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of category IIIa of IIIb chronic prostatitis
* NIH-CPSI (National Institute of Health Chronic Prostatitis Symptom Index) score ≥ 15

Exclusion Criteria:

* Urinary tract infection or uropathogen within the past 12 months
* Serious medical problems
* NIH consensus exclusion criteria13 (presence of active urethritis, urogenital cancer, urinary tract disease, functionally significant urethral stricture, neurological disease affecting the bladder, etc.)
* Drug therapy that might affect lower urinary tract functions within the past 3 months

Primary outcomes:
measure: NIH-CPSI score
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
Study officials:
affiliation: Saint Vincent's Hospital, Korea
name: Hyun-Sop Choe, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choe HS, Lee SJ, Han CH, Shim BS, Cho YH. Clinical efficacy of roxithromycin in men with chronic prostatitis/chronic pelvic pain syndrome in comparison with ciprofloxacin and aceclofenac: a prospective, randomized, multicenter pilot trial. J Infect Chemother. 2014 Jan;20(1):20-5. doi: 10.1016/j.jiac.2013.07.010. Epub 2013 Dec 11.
Clinical trial NCT00434746: Study of the Safety, Tolerability, PK, and PD of ILV-094 Administered IV or SC to Healthy Subjects
Official title: Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ILV-094 Administered IV and One Dose of SC Administered to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-02-13
Enrollment: 56
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of ascending single IV doses of ILV-094 (an investigational drug) and one SC dose of ILV-094 in healthy subjects.

Detailed description: This is a randomized, double-blind, placebo-controlled, inpatient/outpatient, sequential-group study of ascending single IV doses of ILV-094 administered to healthy Japanese male subjects.

Eligibility criteria: Inclusion Criteria:

* Men aged 20 to 45 years inclusive at screening.
* Body mass index in the range of 17.6 to 26.4 kg/m2 and body weight\>45.
* Nonsmoker or smoker of fewer than 10 cigarettes per day. Must be abstain from smoking during inpatient stay.
* Healthy as determined by the investigator on the basis of screening evaluation.

Primary outcomes:
measure: To provide safety, tolerability, PK and immunogenicity profiles
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ikebukuro
country: Japan
state: Tokyo
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03475940: Coagulopathy in Cardiac Surgery
Official title: Coagulopathy in Cardiac Surgery; a Quaternary-care Academic Center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulopathy, Cardiac Surgery, Cardiopulmonary Bypass
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age ≥ 18 years Schedule to cardiac surgery under cardiopulmonary bypass

Brief summary: Coagulopathy in cardiac surgery; a quaternary-care academic center experience

Objectives:

Primary:

To determine incidence of coagulopathy after cardiac surgery in Thai people To determine incidence of resternotomy for stop bleeding, morbidity and mortality

Secondary:

To identify risk factors which associated with non-red cell transfusion and coagulopathy

study decide: Retrospective chart review

Detailed description: Data to be collected:

Age\*, gender\* Body weight, height, body mass index\* Underlying disease: DM, renal disease\*, liver disease\* Pre-op. Antiplatelet or anticoagulant\* Pre-op coagulogram and platelet count\* Emergency or elective surgery Resternotomy or not\* Intraoperative blood component Intraoperative factor concentration Dose and timing of antifibrinolytic administration\* CPB time\* Postoperative body temperature\*

\*Possible risk factors for non-red cell transfusion

statistic: To assess the relationship between risk factors and non-red cell transfusion a univariate analysis was performed using an unpaired t-test and a Chi-square test.

For higher accuracy regarding the impact of single risk factors, a multiple logistic regression analysis was also performed.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Schedule to cardiac surgery under cardiopulmonary bypass

Exclusion Criteria:

* Schedule for aortic surgery or complex congenital cardiac surgery
* Using ECMO before surgery
* Incomplete anesthetic record

Primary outcomes:
measure: incidence of coagulopathy after cardiac surgery in Thai people
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of medicine Siriraj hospital
state: Bangkok
city: Bangkok
country: Thailand
facility: faculty of medicine Siriraj hospital
Study officials:
References:
Clinical trial NCT03998644: Colorectal Cancer Associated Host and Microbiome Study
Official title: A Study Focused on the Host and Microbiome of Colorectal Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Neoplasms
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three different groups were created by healthy volunteers, precancerous and colorectal cancer patients. The information of these individuals will be analyzed and some conclusions will be drawn.

Brief summary: Recruit of healthy, precancer and colorectal cancer patients and record necessary information of demographic and also other messages. All the volunteers were asked to provide samples including stool, blood, urine and tissues. This protocol is performed with the permission of the ethics committee and all the participants were provided with informed consent.

Detailed description: Healthy subjects, precancer patients identified by colonoscopy or colonoscopy history and colorectal cancer patients identified by two independent pathologists will be enrolled. The demographic message including age, weight, height, drug history, family history of all participants will be recorded. Blood, stool and urine samples will be collected of all subjects. Tumor and adjacent tissue samples of colorectal cancer and precancer patients were collected, as well as normal tissue of healthy subjects.

Eligibility criteria: Inclusion Criteria

1. individuals who were clear and signed the informed consent.
2. Male and female.
3. Age \>18

Exclusion Criteria:

1. Any one who can not provide accurate information.
2. Any one who denies the study.
3. Younger than 18.

Primary outcomes:
measure: Gut microbiota structure and function difference between colorectal cancer, precancer and healthy controls
timeFrame: average of 5 years
Secondary outcomes:
measure: Metabolic difference of blood samples between colorectal cancer, precancer and healthy controls
timeFrame: average of 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai 10th People's Hospital
state: Shanghai
Study officials:
References: