louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04284163: Learning Through Gamification in Higher Education
Official title: Learning Through Play in a University Degree: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motivation
Engagement, Patient
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2020-02-25
Enrollment: 106
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: "Health care legislation, management and administration" is a basic subject offered in the physical therapy university degree. The juridical features of this subject usually provokes a lack of motivation between students. Although not commonly used in university teaching, gamification could provide further affordances for improving students' engagement which provokes better assistance and learning outcomes.

Detailed description: * 51 students of "Health legislation, management and administration" subject of the Physical Therapy University Degree of the Catholic University of Murcia will be recruited.
* Participants will be randomly assigned into two groups: control group (traditional teaching methods) and intervention group (gamification).
* Class attendance and academic results will be register for future analysis.

Eligibility criteria: Inclusion Criteria:

* Students enrolled in the subject during academic year 19-20.
* Students included must not have taken the subject before.
* Students must be able to understand and speak the Spanish language.

Exclusion Criteria:

-

Primary outcomes:
measure: Class attendance
timeFrame: Time-to-Event measures: from date of randomization until the end of academic period for a total of 16 week (including two holiday weeks)
measure: Total score
timeFrame: Outcome measures at the end of the academic period, for a total of 16 week (including two holiday weeks)
measure: Partial score
timeFrame: Outcome measures at the end of the academic period, for a total of 16 week (including two holiday weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Catholic University of Murcia
Study officials:
References:
Clinical trial NCT04336735: Improving Immunization Rates in Transplant Candidates Through the Use of a Health Information Technology Tool
Official title: Improving Immunization Rates in Transplant Candidates Through the Use of a Health Information Technology Tool
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transplantation Infection
Vaccination
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2020-04-07
Enrollment: 45
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 45 triads of parents, primary care physicians and subspecialists of children awaiting heart, liver and kidney transplantation will be enrolled to use a novel immunization tool (app).
Primary purpose: SUPPORTIVE_CARE

Brief summary: Vaccine preventable infections are a serious complication following pediatric solid organ transplant. Immunizations are a minimally invasive and cost-effective was to reduce these infections. Despite the importance of pre-transplant vaccination, the majority of pediatric solid organ transplant recipients are not up-to-date on age-appropriate immunizations at the time of transplant. The goal of this study is to pilot a novel health information technology immunization tool to improve immunization rates in pediatric solid organ transplant candidates.

Detailed description: Triads of parents, primary care physicians, and transplant sub-specialists will be enrolled to use a pre-transplant immunization tool while their child awaits transplant. The tool will provide information about vaccines, information about vaccine-preventable infections in the transplant population, a central easily accessible vaccine record, and a communication portal. The tool will also send vaccine reminders when vaccinations are due. The investigators will assess 1) the effectiveness of the tool in improving pre-transplant immunization rates, 2) the acceptability of the tool to users and 3) the feasibility of the tool.

Eligibility criteria: Inclusion Criteria:

* Parent, primary care provider and sub-specialist of a child awaiting heart, liver or kidney transplant

Exclusion Criteria:

* Non English speaking
* No access to a smart phone or computer

Primary outcomes:
measure: Effectiveness of Transplant Immunization Tool, as measured by number of patients with up-to-date vaccinations
timeFrame: Date of transplantation (up to 3 years post-enrollment)
Secondary outcomes:
measure: Acceptability and Feasibility of the Transplant Immunization Tool, as assessed by a questionnaire
timeFrame: Date of transplantation (up to 3 years post-enrollment)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Childrens Hospital Colorado
state: Colorado
Study officials:
affiliation: UCD
name: Amy Feldman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01260935: Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures
Official title: A Prospective Randomized Single-Blinded Multi-Institutional Study Comparing the Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux
Esophageal Reflux
Gastroesophageal Reflux Disease
GERD
Keywords: GERD
laparoscopic surgery
gastroesophageal
reflux
Lead sponsor: Swedish Medical Center
Sponsor class: OTHER
First posted: 2010-12-15
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
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 compare the effects (good and bad) of the Laparoscopic Hill anti-reflux procedure with the Laparoscopic Nissen anti-reflux surgical procedure to see whether one is better than the other.

Detailed description: The design is a two-armed prospective single-blinded comparison between the two procedures, performed and randomized independently at the Swedish Medical Center Cancer Institute in Seattle, WA, and at Legacy Health Systems in Portland, OR, in adult patients with uncomplicated gastroesophageal reflux failing medical management. A standardized operative technique for each procedures will be utilized at both institutions, and will include intraoperative manometrics and intraoperative photographic documentation of the gastroesophageal valve, as well as placement of clips at the GE junction to accurately identify its location post-operatively. To eliminate "expertise" bias, the investigator from each institution will participate in up to 50 of the first of each of the two procedures.

Eligibility criteria: Inclusion Criteria:

* abnormal levels of gastroesophageal reflux documented by pH monitoring who are failing medical management or are requiring maximal medical therapy for control
* \> 18 years of age and \< 75 years of age

Exclusion Criteria:

* hiatal hernias measuring \> 7 cm
* esophageal body amplitude \< 30 or in two or more segments
* \< 40% propagated peristaltic waves
* GE junction \> 5 cm above the esophageal hiatus
* dense fibrotic esophageal strictures which do not markedly improve with pre-operative medical therapy
* body mass index \> 40

Primary outcomes:
measure: Determine whether Laparoscopic Hill repair is as effective as Nissen fundoplication for the treatment of gastroesophageal reflux disease (GERD).
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Swedish Medical Center Cancer Institute
state: Washington
Study officials:
affiliation: Swedish Medical Center Cancer Institute
name: Ralph Aye, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02128035: RADIATION PROTECTion With a Pelvic Lead Shield and a Radiation Protection Cap for Operators Performing Coronary Angiography or Intervention
Official title: Radiation Protection With a Pelvic Lead Shield and a Radiation Protection Cap for Operators Performing Coronary Angiography or Intervention, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndromes
Keywords: radiation protection
interventional cardiologist
percutaneous coronary intervention (PCI)
angiography
lead shield
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: McMaster University
name: Population Health Research Institute
First posted: 2014-05-01
Enrollment: 230
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: RADIATION PROTECT is a randomized, controlled trial of patients undergoing coronary angiography or PCI with or without a pelvic lead shield. Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures.

It is hypothesized that routine use of the pelvic lead shield and radiation protection cap during these procedures will reduce the amount of radiation in which the interventional cardiologists get exposed.

Detailed description: Patients referred for coronary angiography or PCI will be randomized to undergo their procedure with or without the pelvic lead shield and the operator will wear a radiation protection cap.

Clinical efficacy will be assessed based on the total radiation dose that the interventional cardiologist got exposed to as well as a secondary outcome measuring the total radiation exposure dose per minute.

Eligibility criteria: Inclusion Criteria:

* Patient referred for coronary angiography or Percutaneous Coronary Intervention (PCI)

Exclusion Criteria:

* Age ≤ 18 years
* Previous inclusion in RADIATION PROTECT trial

Primary outcomes:
measure: Total Radiation Dose
timeFrame: Duration of Procedure (an expected average of 30 minutes)
Secondary outcomes:
measure: Radiation Exposure Dose per minute
timeFrame: Duration of Procedure (an expected average of 30 minutes)
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences, McMaster University
name: Sanjit S Jolly, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamilton Health Sciences Corporation
name: Ashraf Al Azzoni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alazzoni A, Gordon CL, Syed J, Natarajan MK, Rokoss M, Schwalm JD, Mehta SR, Sheth T, Valettas N, Velianou J, Pandie S, Al Khdair D, Tsang M, Meeks B, Colbran K, Waller E, Fu Lee S, Marsden T, Jolly SS. Randomized Controlled Trial of Radiation Protection With a Patient Lead Shield and a Novel, Nonlead Surgical Cap for Operators Performing Coronary Angiography or Intervention. Circ Cardiovasc Interv. 2015 Aug;8(8):e002384. doi: 10.1161/CIRCINTERVENTIONS.115.002384.
Clinical trial NCT00573235: Epidemiology of Community - Associated Extended-spectrum Beta-lactamases (ESBL) Producing Escherichia Coli
Official title: Epidemiology of Community - Associated Extended-spectrum Beta-lactamases (ESBL) Producing Escherichia Coli
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enterobacteriaceae Infections
Keywords: isolates
infection
E coli isolates
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2007-12-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with E. coli, Klebsiella species and Proteus species infections during the time period of the study will be reviewed.

Brief summary: The purpose of this study is to review patients with E. coli infections at the University of Pittsburgh Medical Center (UPMC) from July 1, 2007 to June 30, 2010 to determine if these infections have arisen in the community rather than in hospitals or nursing homes.

Detailed description: This is chart review at UPMC. There is no human interaction.

Eligibility criteria: Inclusion Criteria:

* All patients with E. coli, Klebsiella species and Proteus species infections during the time period of the study will be reviewed.

Primary outcomes:
measure: Review whether ESBL-producing organisms (E. coli, Klebsiella species and Proteus species) are hospital-acquired, healthcare-associated or community-associated.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Yohei Doi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04605835: Ultrasonic Visualization of Obstructive Uropathies in Children
Official title: Ultrasonic Visualization of Renal Function Damage and Urodynamic Disorders for Obstructive Uropathies in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Uropathy
Keywords: obstructive uropathy
children
ultrasound
Doppler
Lead sponsor: Samarkand State Medical Institute
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 655
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 60 in children with obstructive uropathies (30 children with congenital hydronephrosis and 30 children with congenital ureterohydronephrosis).

Brief summary: The purpose of this study was to develop proposals and recommendations for improving the safety of urological examination of children with obstructive uropathy by using Doppler ultrasound. Based on the results of a comprehensive urological examination of 665 children with congenital ureteral obstruction, a program for scoring the results of ultrasound examination has been developed, which allows using the safest and most informative methods to reliably determine the functional state of the renal parenchyma and the degree of urodynamic disorders in children with obstructive uropathy.

Detailed description: Relevance. The prevalence of congenital diseases of the genitourinary system is 0.5-7.5 per 1000 newborns; The high prevalence reflects the medical and social significance of the problem and determines the need to search for highly informative and safe diagnostic methods for the child's body, providing timely treatment, restoration of the somatic and social status of children.

Purpose. Development of proposals and recommendations to improve the safety of urological examination of children with obstructive uropathy.

Material and methods. The study is based on the analysis of the results of diagnosis and treatment of 655 children with congenital obstruction of the upper urinary tract. The complex of urological examination included clinical, laboratory, morphological, radiological, ultrasound research methods.

Eligibility criteria: Inclusion Criteria:

* 655 children with congenital obstruction of the upper urinary tract

Exclusion Criteria:

* none

Primary outcomes:
measure: Ultrasonic visualization of renal function damage and urodynamic disorders for obstructive uropathies in children.
timeFrame: up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Samarkand
country: Uzbekistan
facility: Samarkand State Medical Institute
Study officials:
References:
Clinical trial NCT00651235: A Randomized, Open-label, LOSARTAN Therapy on the Progression of Aortic Root Dilation in Patients With Marfan Syndrome
Official title: A Randomized, Open-label, Active Control Trial to Evaluate the Effect of LOSARTAN Therapy on the Progression of Aortic Root Dilation in Patients With Marfan Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Marfan Syndrome
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-04-02
Enrollment: 44
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: To assess the efficacy of angiotensin II receptor blocker, Losartan, to prevent progressive dilation of aortic root in patients with Marfan syndrome.

Detailed description: Marfan syndrome (MFS) is a multisystem connective tissue disorder of autosomal dominant inheritance1. The cardinal features are noted in the cardiovascular, ocular, and skeletal system. The most life-threatening complication of MFS is progressive aortic root dilation leading to aortic dissection or rupture. Losartan, an angiotensin II type I receptor (AT1) antagonist, is a drug already in clinical use for hypertension and type II diabetic nephropathy. A recent study showed that Losartan prevents aortic root dilation and lung problem in a mouse model of MFS. Therefore, the goals of this clinical trial are to examine the efficacy and safety of Losartan in patients with Marfan syndrome for aortic root dilation prevention.

Eligibility criteria: Inclusion criteria

* Marfan syndrome with recognized aortic root dilation
* Patients must be older than one year of age
* Beta-blocker treatment at least three months
* Must sign an informed consent form

Exclusion criteria

* Prior to aortic root surgery
* Aortic root dimension more than 5.5cm
* Aortic surgery within 6 months
* Diabetes mellitus or liver and renal dysfunction or asthma
* Pregnancy
* Intolerance to Losartan therapy

Primary outcomes:
measure: Echocardiograms
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Mei-Hwan Wu
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chiu HH, Wu MH, Wang JK, Lu CW, Chiu SN, Chen CA, Lin MT, Hu FC. Losartan added to beta-blockade therapy for aortic root dilation in Marfan syndrome: a randomized, open-label pilot study. Mayo Clin Proc. 2013 Mar;88(3):271-6. doi: 10.1016/j.mayocp.2012.11.005. Epub 2013 Jan 12.
Clinical trial NCT02835235: A Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects Being Overweight or With Obesity
Official title: A Double-blinded Placebo-controlled Multiple Dose Trial Investigating Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects Being Overweight or With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2016-07-18
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America. The aim of the trial is to investigate Safety, Tolerability, PK and PD for Multiple Doses of NNC9204-0530 in Male and Female Subjects being overweight or with obesity


Eligibility criteria: Inclusion Criteria:

* Male or female, age between 18 and 55 years (both inclusive) at the time of signing informed consent
* Body mass index between 25.0 and 39.9 kg/m\^2 (both inclusive) at screening.

Exclusion Criteria:

* Haemoglobin A1c (HbA1c) equal or above 6.5%
* Any clinically significant weight change (above or equal to 5% self-reported change) or dieting attempts (e.g. participation in an organized weight reduction program) within the last 90 days prior to screening
* Any prior obesity surgery or currently present gastrointestinal implant.
* Abnormal ECG (electrocardiogram) results including 2nd or 3rd degree AV-block, prolongation of the QRS complex above 120 ms, or the QTcF interval above 430 ms (males) or above 450 ms (females), or other clinically relevant abnormal results, as judged by the investigator
* A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
* History of pancreatitis (acute or chronic)

Primary outcomes:
measure: Number of treatment emergent adverse events
timeFrame: Day 1-112
Secondary outcomes:
measure: Area under the NNC9204-0530 serum concentration-time curve
timeFrame: Day 84-112
measure: Time to maximum serum concentration of NNC9204-0530
timeFrame: Day 84-112
measure: Change in HbA1c
timeFrame: Day -1, Day 85
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Lincoln
country: United States
facility: Novo Nordisk Investigational Site
state: Nebraska
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05176535: Determination of Vaginal Colonization and the Effect of an Oral Probiotic (PROSALVAG)
Official title: Study to Determine Vaginal Colonization and Effect of an Oral Probiotic That Contains L.Rhamnosus, L. Plantarum and L. Crispatus in Women (PROSALVAG)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Microbial Colonization
Dysbiosis
Fertility Issues
Lead sponsor: Fertypharm
Sponsor class: INDUSTRY
First posted: 2022-01-04
Enrollment: 55
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to determine the efficacy of an oral nutraceutical with probiotics in restore vaginal health.

Detailed description: After being informed about the study, all patients meeting the inclusion/exclusion criteria and giving written informed consent will receive a nutraceutical containing L. rhamnosus, L. plantarum and L. crispatus once daily.

Eligibility criteria: Inclusion Criteria:

* Aged: 35-43 years old
* Vaginal pH \> 4,5 and low Lactobacillus count or Nugent score of 4-6
* With interest in getting pregnant and ideally in IVF waiting list
* History of recurrent genitourinary infections

Exclusion Criteria:

* Any pathology that interferes with the study
* Current intake of food supplements or probiotics
* Current intake of contraceptives
* Use of oral or vaginal probiotics in the last 6 months
* Hypersensitivity to any of the components of the studied product
* Current vaginal infection
* Pregnant women
* Breastfeeding
* Use of intrauterine device
* Use of spermicide
* Use of cervical caps as hormonal therapy

Primary outcomes:
measure: Rectal and vaginal colonization
timeFrame: 10 weeks
Secondary outcomes:
measure: Autoinmune capacity
timeFrame: 10 weeks
measure: Antioxidant effect
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: HM Fertility Centter Vallés
state: Madrid
Study officials:
References: