louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04666532: S. Aureus Translocation From Skin and Nose to Periprosthetic Tissues
Official title: Staphylococcus Aureus Translocation From Skin and Nose to Periprosthetic Tissues
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Staphylococcus Aureus
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who are undergoing revision total knee or hip arthroplasty by one of the joints surgeons at Rothman Orthopaedics

Brief summary: Surgical site infections (SSI) are a significant clinical issue that requires the use of a great amount of resources. In particular, periprosthetic joint infections (PJIs) have potentially catastrophic effects on patients' health-related quality of life, function, healthcare costs, outcomes and medical implications. National surveillance estimates may under-report the true incidence and when considering the large number of total hip (THA) and total knee arthroplasty (TKA) procedures performed each year.

Patients who have a high-level of nasal bacteria have been found to have a risk of surgical site infection that is three to six times the risk compared with noncarriers and low-level carriers. The association between a patient's nasal carriage of S. aureus, specifically MRSA, and PJI has been demonstrated in a systematic review and confirmed in recent cohort studies. While this association seems to be well accepted, no mechanistic explanation has been provided for this association.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing revision total knee or total hip arthroplasty at our institution will be eligible

Exclusion Criteria:

* Patients included in other prospective studies

Primary outcomes:
measure: S. aureus Culture and Next Generation Sequencing
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Orthopaedic Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00860132: Economic Aspects Associated With the Implementation of an Orthogeriatric Setting in a General Hospital
Official title: Economic Aspects Associated With the Implementation of an Orthogeriatric Setting in a General Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hip Fracture
Keywords: hip fracture elderly orthogeriatric
cost effectiveness of hip fracture patients
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-03-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: approx 1000 patients admitted with traumatic hip fracture to an orthogeriatric ward, compared with approximately 1000 admissions to orthopaedic ward

Brief summary: The economic and social burden of hip fractures is expected to increase dramatically, but financial resources remain limited. This calls for the investigation of innovative new forms of organization and integration of medical, surgical and rehabilitation services for these patients.

The study will investigate economical aspects associated with implementation of a comprehensive orthogeriatric ward for elderly hip fracture patients in a general hospital, compared with the classic model of orthopedic treatment followed by rehabilitation period.


Eligibility criteria: Inclusion Criteria:

* hip fracture

Exclusion Criteria:

* Patients admitted for elective hip surgery
* Patients with multi-trauma injuries

Primary outcomes:
measure: cost-effectiveness
timeFrame: 1999-2007
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04076332: How "Shared Decision Making Decision-aid" Help Patients With Obstructive Sleep Apnea to Choose Treatment Plan
Official title: How "Shared Decision Making Decision-aid" Help Patients With Obstructive Sleep Apnea to Choose Treatment Plan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shared Decision Making
OSA - Obstructive Sleep Apnea
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2019-09-03
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Shared decision-making helps patients to establish a treatment plan with clinicians together. Our goal was to determine if the tools we developed could reduced decisional conflict for patients with obstructive sleep apnea.

Detailed description: Shared decision-making helps patients to establish a treatment plan with clinicians together. Our goal was to determine if the tools we developed could reduced decisional conflict for patients with obstructive sleep apnea.

Inclusion criteria: include obstructive sleep apnea patient from the outpatient clinic of Dean Wu, the sleep center of Shuang-He Hospital, 20-80 years old, polysomnography showed moderate severity (AHI ≥ 15), can communicate in Chinese.

Exclusion criteria: dementia, mental illness, language difficulties.

Eligibility criteria: Inclusion Criteria:

* Include obstructive sleep apnea patient from the outpatient clinic of Dean Wu, the sleep center of Shuang-He Hospital, 20-80 years old, polysomnography showed moderate severity (AHI ≥ 15), can communicate in Chinese

Exclusion Criteria:

* Exclude dementia, mental illness, language difficulties

Primary outcomes:
measure: Decision conflict
timeFrame: Immediately after patient received standard oral explanation with booklet or decision aids at out-patient department
Secondary outcomes:
measure: Health literacy
timeFrame: Immediately after patient received standard oral explanation with booklet or decision aids at out-patient department
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
Study officials:
affiliation: Taipei Medical University Shuang Ho Hospital
name: Dean Wu, MD, PhD
role: STUDY_CHAIR
References:
citation: Kapur VK, Auckley DH, Chowdhuri S, Kuhlmann DC, Mehra R, Ramar K, Harrod CG. Clinical Practice Guideline for Diagnostic Testing for Adult Obstructive Sleep Apnea: An American Academy of Sleep Medicine Clinical Practice Guideline. J Clin Sleep Med. 2017 Mar 15;13(3):479-504. doi: 10.5664/jcsm.6506.
citation: Epstein LJ, Kristo D, Strollo PJ Jr, Friedman N, Malhotra A, Patil SP, Ramar K, Rogers R, Schwab RJ, Weaver EM, Weinstein MD; Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009 Jun 15;5(3):263-76.
Clinical trial NCT03089437: The Effects of Prolonged Standing Compared to Prolonged Sitting on Postprandial Lipemia
Official title: The Effects of Prolonged Standing Compared to Prolonged Sitting on Postprandial Lipemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Atherosclerosis
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2017-03-24
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The effects of 12 hours of prolonged standing will be compared to prolonged standing on a high fat tolerance test the following day. Plasma triglycerides, insulin, and glucose will be measured in a crossover study design.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* heart problems
* coronary artery disease
* hypertension
* respiratory problems
* musculoskeletal problems that prevent prolonged standing or sitting
* obesity
* susceptibility to fainting

Primary outcomes:
measure: Plasma Triglycerides
timeFrame: 6 hours
measure: Plasma Insulin
timeFrame: 6 hours
measure: Plasma Glucose
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin Human Performance Laboratory
state: Texas
Study officials:
References:
Clinical trial NCT03352037: 18F-FDG PET/MR Imaging for Differentiation of Serous From Non-Serous Pancreatic Cystic Neoplasms: A Pilot Study
Official title: 18F-FDG PET/MR Imaging for Differentiation of Serous From Non-Serous Pancreatic Cystic Neoplasms: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cystic Neoplasms
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The overlap of morphological imaging features results in many incidentally detected pancreatic cystic neoplasms going undiagnosed, including benign serous cystic neoplasms (SCN) and potentially malignant mucinous lesions (nonserous). The diagnostic ambiguity then lead to invasive procedures such as endoscopic ultrasonography (EUS), unwarranted surgical resection on SCN lesions or the need for long term periodic surveillance with delayed diagnosis of potentially malignant nonserous lesions. Therefore, precise differentiation of SCN from nonserous cystic neoplasms is highly desirable.

The 18F-fluorodeoxyglucose (FDG) accumulation in tumor cells, which is induced by high expression of glucose transporter proteins (mainly include GLUT-1 and -3), can be used to discriminate malignant and benign pancreatic cystic tumors in positron emission tomography (PET) imaging. GLUT-1 expression has also been documented in benign SCN while no such evidence exists in potentially malignant nonserous cystic neoplasms. Based on this evidence, investigators will conduct a pilot study to evaluate if integrated 18F-FDG PET/MR imaging with simultaneous MR and PET acquisition is helpful in differentiation of SCN from nonserous lesions.


Eligibility criteria: Inclusion Criteria:

-Patients with known pancreatic cystic lesions, including suspected pancreatic serous cystic neoplasms and non-serous cystic neoplasms

Exclusion criteria:

* General Contraindications to MRI such as pacemaker, brain aneurysm clip etc. -
* Pregnancy
* Age below 18 years
* Estimated GFR (eGFR \< 30 mL/min)
* MRI contrast allergy;

Primary outcomes:
measure: Investigation of 18F-FDG PET/MRI efficacy in differentiating pancreatic cystic neoplasms
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Kartik Jhaveri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03484637: Response Evolution Chart
Official title: Adherence to an Overweight and Obesity Treatment: the Evolution Chart
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Overweight
Motivation
Adherence, Patient
Keywords: motivation
Treatment adherence
Waist circumference
obesity
overweight
Lead sponsor: BiomediKcal
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Overweight and obese participants who consulted a medical nutrition clinic

Brief summary: This study evaluates patient response to a motivation evolution chart for a medical-nutrition intervention as a continuation of a previous study: adherence to an overweight and obesity treatment available at: https://www.ncbi.nlm.nih.gov/pubmed/25101227


Eligibility criteria: Inclusion Criteria:

* Voluntary assistance
* Clinical diagnosis of overweight
* Clinical diagnosis of obesity
* Patient desire to improve their aesthetic image and health status

Exclusion Criteria:

* This study does not consider patients who tried a diet to lose weight in the previous month or earlier

Primary outcomes:
measure: Evolution registration by photograph
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: BiomediKcal - Advanced Medical Nutrition & Lifestyle Center
state: Atlantico
Study officials:
References:
citation: Kuzmar IE, Cortes-Castell E, Rizo M. Effectiveness of telenutrition in a women's weight loss program. PeerJ. 2015 Feb 3;3:e748. doi: 10.7717/peerj.748. eCollection 2015.
citation: Kuzmar I, Cortes E, Rizo M. Age group, menarche and regularity of menstrual cycles as efficiency predictors in the treatment of overweight. Nutr Hosp. 2014 Oct 30;31(2):637-41. doi: 10.3305/nh.2015.31.2.7501.
citation: Kuzmar I, Rizo M, Cortes-Castell E. Adherence to an overweight and obesity treatment: how to motivate a patient? PeerJ. 2014 Jul 29;2:e495. doi: 10.7717/peerj.495. eCollection 2014.
Clinical trial NCT04570137: Fiber Fermentation Study
Official title: Effects Dietary Fiber From Grains or Fruits and Vegetables on the Intestinal Production of Short-chain Fatty Acids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Health
Keywords: Gastroenterology
Gut microbiome
Gut barrier
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Two-armed crossover trial
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to better understand the interplay between the intake of dietary fiber and intestinal bacteria, their metabolic activity and the effect on the intestinal barrier.

The effect of two different dietary fiber supplements is tested (arabinoxylan \& ß-glucan versus inulin \& fructooligosaccharides) in a randomized crossover intervention trial including healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* 18 to 65 years
* signed written informed consent
* willingness not to change the dietary pattern in the course of the study

Exclusion Criteria:

* BMI below 18 or above 30
* acute or chronic gastrointestinal symptoms
* neoplastic diseases
* very strict diets, including raw foodists and frutarians
* regular smoking (more than one box per day)
* intake of antibiotics, immunosuppressants, or any intestinal therapeutics three months prior to study begin
* supplementation of fibers three months prior to study begin
* simultaneous participation in another clinical study
* pregnancy / breastfeeding
* relevant violations of the study protocol
* intolerance to the fiber supplements (including wheat, oat, chicory)
* occurrence of relevant diseases (individual decision by study physicians)
* revocation of consent
* placement in a clinic or similar facility based on an official or court order

Primary outcomes:
measure: Short-chain fatty acids (SCFAs)
timeFrame: Will be measured in approx. 4 weeks after study completion.
Secondary outcomes:
measure: Gut microbiome composition
timeFrame: Will be measured in approx. 6-8 weeks after study completion.
measure: Gut barrier integrity
timeFrame: Will be measured in approx. 4 weeks after study completion.
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: Institute of Nutritional Medicine, University of Hohenheim
Study officials:
affiliation: University of Hohenheim, Institute of Nutritional Medicine
name: Stephan C Bischoff, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05026437: CASUS vs. APACHE II in Predicting Mortality After Coronary Artery Bypass Grafting
Official title: The Value of CASUS vs. APACHE II in Predicting Mortality Among Patients Undergoing Coronary Artery Bypass Grafting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Bypass Grafting
Mortality
Keywords: cardiac surgery score, mortality, ICU
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
name: Haydarpasa Numune Training and Research Hospital
First posted: 2021-08-30
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population includes all adult patients who undergoing coronary artery bypass grafting during the study period.

Brief summary: The study seeks to determine the value of CASUS in predicting mortality as compared with APACHE II scoring system among patients undergoing coronary artery bypass grafting.

Detailed description: Patients undergoing coronary artery bypass grafting will prospectively studied after the admission to the cardiac intensive care unit. Data on the preoperative condition, intraoperative parameters, and postoperative course will collected. CASUS and APACHE II scores will calculated on the first postoperative day. Clinical outcomes are defined as 7-day mortality, 30-day mortality and morbidity. Morbidity includes variables such as length of stay in the cardiac surgical intensive care unit and in the hospital.

Eligibility criteria: Inclusion Criteria:

* Undergoing coronary artery bypass grafting
* Over 18 years of age
* Staying at least 24 hours in the cardiac intensive care unit

Exclusion Criteria:

* Emergency surgery

Primary outcomes:
measure: Mortality at 7 days
timeFrame: 7 days
measure: Mortality at 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Length of stay in the cardiac intensive care unit
timeFrame: Up to 3 months (Through study completion)
measure: Length of the stay in the hospital
timeFrame: Up to 3 months (Through study completion)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital in Turkey
city: Istanbul
country: Turkey
facility: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Study officials:
affiliation: Dr. Siyami Ersek Thoracic and Cardiovascular Surgery TRH
name: Nihan YAPICI
role: STUDY_DIRECTOR
affiliation: Haydarpaşa Numune Training and Research Hospital
name: Sümeyye UĞUR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06001437: Following Outcomes Remotely Within Addiction Recovery Domains
Official title: CTN-0126 Following Outcomes Remotely Within Addiction Recovery Domains
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Opioid Use Disorder
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-08-21
Enrollment: 1600
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: Adults with opioid use disorder who have previously participated in one of two applicable opioid use disorder clinical trials in the NIDA Clinical Trials Network.

Brief summary: The aim of this study is to describe outcome of people with opioid use disorder over the long-term by collecting monthly and yearly data on their recovery. Adults with opioid use disorder who participate will complete surveys monthly online and once per year by phone about their substance use, mental health, treatment involvement and functioning. The goal of this study is to better understand how people with opioid use disorder recover over time to improve intervention for this group.

Detailed description: This is a longitudinal follow-up study that will collect yearly outcomes data on adults with opioid use disorder (OUD) who participated one of two prior clinical trials in the NIDA Clinical Trials Network. This longitudinal, observational study will entail annual phone and online assessments of domains of interest (e.g., substance use, treatment engagement) as well as monthly assessments that are distributed via text messaging and email to be completed electronically by the participant. No participant randomization will occur for this study, and study data will be considered observational in nature. We aim to characterize the long-term course of OUD and to evaluate the long-term course and recovery of OUD.

Eligibility criteria: Inclusion Criteria:

1. Be an enrolled participant in one of two applicable clinical trials and be no longer than 24 months after the final expected assessment for that trial.
2. Be willing and able to provide locator information for survey distribution (mobile number and/or email address).
3. Be willing to allow the linkage of prior clinical trial study data to the current study record.

Exclusion Criteria:

1. Unable to understand or communicate to complete consent or study assessments.
2. Are currently in jail, prison or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities.
3. Other factors that would cause harm or increased risk to the participant or close contacts or preclude the participant's full adherence with or completion of the study.

Primary outcomes:
measure: Opioid Use
timeFrame: 12 months
measure: Engagement in Treatment
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
References: