louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02486575: Trial on Laparoscopic Simulation Based on Mentoring
Official title: Comparison of Laparoscopic Simulation Training Between Mentoring and Self-learning Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Performance of Wrong Procedure (Operation)
Keywords: Residents
Training
simulation
mentoring
proctor
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 60
Sex: ALL
Minimum age (years): 24
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: More than 50 residents in surgical specialities (OB\&G, General surgery and Urology) from a single university in Italy will be randomized into two groups, after a stratification based on residency year and laparoscopic/simulator experience. The first one will train to FLS (fundamentals of laparoscopic surgery) following pre-recorded instruction from course materials; the second one will be mentored by a proctor in single training section. The aim is to evaluate the best way to train residents applying for the very first time in an extensive way the "fundamentals of laparoscopic surgery" program in an Italian Institution.

Detailed description: A complete 5-skills based FLS (fundamentals of laparoscopic surgery) curriculum is proposed to each resident enrolled in the trial. The first group trains with videos and written instructions, without any kind of support from a tutor. The second group is aided by a tutor, receiving tailored teaching and mentoring.

The primary goal was to asses the impact of tutoring in Passing the FLS examination at the end of a 3-months training: the outcome is the dichotomous PASS/DON'T PASS THE EXAM. At the same time the investigators assess the performance to record and evaluate any differences in groups and subgroups (year of residency, gender, specialty, etc.).

The evaluation was based on FLS program standards, recording time and penalties.

The training and evaluation setting was created to exactly reproduce the FLS one, mostly using the FLS material itself, or using FLS admitted/compatible instrumentation.

Eligibility criteria: Inclusion Criteria:

* Residents in surgical specialities at University of Brescia

Exclusion Criteria:

* Residents not available for the training (outside the Country, not interested, etc.)

Primary outcomes:
measure: Performance at FLS (fundamentals of laparoscopic surgery) test at the end of training as defined from SAGES
timeFrame: 2 months to compleete the training
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Università degli Studi di Brescia
name: Nazario Portolani, MD
role: STUDY_DIRECTOR
References:
citation: Gheza F, Raimondi P, Solaini L, Coccolini F, Baiocchi GL, Portolani N, Tiberio GAM. Impact of one-to-one tutoring on fundamentals of laparoscopic surgery (FLS) passing rate in a single center experience outside the United States: a randomized controlled trial. Surg Endosc. 2018 Nov;32(11):4428-4435. doi: 10.1007/s00464-018-6185-1. Epub 2018 Apr 11.
Clinical trial NCT01648075: Effect of the Consumption of Probiotics in the Reduction of Incidence of Carious Lesions in Preschool Children
Official title: Effect of the Consumption of Probiotics Lactobacilli Enriched Milk in the Reduction of Incidence of Carious Lesions in Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caries Reduction
Caries Prevention
Keywords: caries
probiotics
lactobacilli
Lead sponsor: University of Chile
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 261
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Probiotics are microorganisms that when administered in adequate amounts can confer health benefits. In vitro and clinical studies support the idea that lactobacilli have protective effects on oral health. A recent study in which preschoolers consumed milk drinks enriched with Lactobacillus rhamnosus, reported a reduction in caries, as well as additional benefits to children.

The aim of this study is to evaluate the effect of daily consumption of milk beverages enriched with Lactobacillus rhamnosus on the incidence of caries in preschool Chilean children.

Detailed description: In this randomized controlled trial, preschool children belonging to Integra Foundation will be invited to participate. After obtaining parent´s informed consent, clinical and microbiological testing of saliva at baseline, 6 m, 12m and 18m will be performed. Differences in prevalence and incidence of caries, dmft and microbial diversity between groups will be assessed.

Eligibility criteria: Inclusion Criteria:

* Healthy children from a general health perspective, with or without cavitated carious lesions at baseline.

Exclusion Criteria:

* Children with systemic disorders who need special care and / or who have intolerance to milk drinks or allergy to any of the components of the experimental and / or placebo beverage.

Primary outcomes:
measure: Reduction of caries incidence in 1 unit of DMF-T (decayed, missing and filled teeth) from baseline up to the 18th month
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Integra Preschools
state: Metropolitan Region
Study officials:
References:
citation: Rodriguez G, Ruiz B, Faleiros S, Vistoso A, Marro ML, Sanchez J, Urzua I, Cabello R. Probiotic Compared with Standard Milk for High-caries Children: A Cluster Randomized Trial. J Dent Res. 2016 Apr;95(4):402-7. doi: 10.1177/0022034515623935. Epub 2016 Jan 8.
Clinical trial NCT01579175: The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery
Official title: The Effect of Gum Chewing on Postoperative Ileus After Gynecologic Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Postoperative Ileus
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2012-04-17
Enrollment: 294
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators are randomizing patients to receive chewing gum (Extra Sugar Free, Spearment) every 4 hours during waking hours for 15 minutes versus standard postoperative care. The investigators then have them fill out a survey in house and 1 week after their surgery that record time to first flatus, hunger, toleration of clear liquids and food and some information about pain, satisfaction, and quality of life. The investigators contact them via phone and email a maximum of three times in order to collect this information. 30 days postoperatively the investigators also contact them and perform a chart review for any postoperative complications.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Undergoing benign gynecologic surgery via an exploratory laparotomy
* Capable of giving consent

Exclusion Criteria:

* Oromaxillary or mental disturbances that would make chewing gum dangerous with regards to mastication or aspiration
* Intubated or unconscious when leaving the OR
* Bowel resection performed at the time of surgery
* Active bowel disease (IBD, appendicitis, etc)
* Gynecologic malignancy

Primary outcomes:
measure: Time to flatus
timeFrame: 30 days
Secondary outcomes:
measure: Postoperative ileus
timeFrame: 30 days
measure: time to discharge
timeFrame: 30 days
measure: time to toleration of diet
timeFrame: 30 days
measure: patient satisfaction
timeFrame: 30 days
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Catherine A Sewell, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Amelia M Jernigan, MD
role: STUDY_CHAIR
affiliation: Johns Hopkins Bayview
name: Grace Chen, MD
role: STUDY_DIRECTOR
References:
citation: Jernigan AM, Chen CC, Sewell C. A randomized trial of chewing gum to prevent postoperative ileus after laparotomy for benign gynecologic surgery. Int J Gynaecol Obstet. 2014 Dec;127(3):279-82. doi: 10.1016/j.ijgo.2014.06.008. Epub 2014 Jul 21.
Clinical trial NCT03832075: Validity of Korebalance Balance System
Official title: Validity of Korebalance Balance System in Postmenopausal Osteoporotic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporosis, Postmenopausal
Balance; Distorted
Keywords: osteoporosis
balance
berg balance scale
korebalance balance system
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 53
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In postmenopausal osteoporosis patients, the balance is impaired. Equilibrium is evaluated with various test and balance systems. This study aims evaluation of the patients with the Korebalance Balance System and balance tests and investigation the validity of the Korebalance Balance System.

Detailed description: 53 postmenopausal osteoporosis patients were evaluated with balance tests (Berg Balance Scale (BBS) and Timed Up and Go Test (TUG)) and Korebalance Balance System. The Korebalance Balance System is a balance assessment and exercise system. The higher the score, the greater the deterioration in the balance. The results of static and dynamic balance evaluation are recorded as score values. In this study, investigators compared Korebalance Balance System, Berg Balance Scale (BBS) and Timed Up and Go (TUG) tests and other demographic and clinical parameters (age, body mass index (BMI), 25OHvitD level, menopause age, fall within the last 1 year, fracture history, history of fracture in mother).

Eligibility criteria: Inclusion Criteria:

* Having postmenopausal osteoporosis
* No other disease that can cause balance disorder
* Volunteer participation in the study

Exclusion Criteria:

* To have a disease that will cause balance disorder,
* Having understanding problem to prevent communication with the patient,
* The lack of motor function to the balance device.

Primary outcomes:
measure: Evaluate validity of Korebalance Balance System in postmenopausal osteoporotic patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University Faculty of Medicine, Physical Therapy and Rehabilitation Department
Study officials:
References:
Clinical trial NCT02925975: Early Precise Diagnosis and Intervention of CPT Based on a Noninvasive 3D-vHPS
Official title: Early Precise Diagnosis and Intervention of Cirrhotic Portal Hypertension (CPT) Based on a Noninvasive 3D-virtual-model of Hepatic Portal System (3D-vHPS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Portal Hypertension
Cirrhosis
Lead sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Changzheng Hospital
name: Shanghai 10th People's Hospital
First posted: 2016-10-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the possibilities of early and precise management to decrease portal vein pressure in cirrhotic patients, guided by a non-invasive 3D-virtual-model of hepatic portal system (3D-vHPS). Healthy volunteers are enrolled to determine the normal range of pressure density in different sites of HPS. Cirrhotic patients without visible gastro-esophageal varies by endoscopy are randomly enrolled to virtual portal vein pressure gradient (vPVPG) monitored or non-vPVPG monitored groups. Non-vPVPG groups are followed-up and treated according to Baveno V consensus in portal hypertension. Patients in vPVPG-monitored groups are followed-up by anatomic computed tomographic angiography (CTA) and Doppler ultrasound every six months. Once vPVPG is above 12mm of mercury (Hg), participants will receive carvedilol treatment. All cirrhotic patients are followed-up with the incidence of portal hypertension-related complications, mortality rate and life quality assessment.

Detailed description: The non-invasive 3D-HPS is a newly-developed test to determine vPVPG based on anatomic computed tomographic angiography (CTA) and Doppler ultrasound. In this study, vPVPG is determined by the 3D-HPS.

Eligibility criteria: Inclusion Criteria:

* Proven cirrhosis based on histology or unequivocal clinical, sonographic and laboratory findings
* Child-Pugh score \< 9
* No visible gastro-esophageal varies by endoscopy

Exclusion Criteria:

* Patients with malignant diseases
* Treatment with vasoactive drugs
* Prior transjugular intrahepatic portosystemic stent-shunt surgery
* Patients with known allergy to iodinated contrast
* Treatment with immunosuppressants
* Renal sufficiency
* Patients with coronary artery diseases, or treated with anticoagulants
* Pregnancy
* Inability to adhere the follow-up
* Any life-threatening disease

Primary outcomes:
measure: Incidence of portal hypertensive complications: ascites and variceal bleeding
timeFrame: 3 years
measure: 10% decrease of virtual hepatic venous pressure gradient (HVPG) from baseline level
timeFrame: 3 years
Secondary outcomes:
measure: Mortality rate
timeFrame: 3 years
Other outcomes:
measure: Quality of life
timeFrame: 3 years
Locations:
city: Shanghai
country: China
facility: Shanghai Tongji Hospital, Tongji University School of Medicine
Study officials:
References:
Clinical trial NCT01390675: Anesthesia for Catheter Aortic Valve ImplantATIOn Registry
Official title: Anesthesia for Catheter Aortic Valve ImplantATIOn Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Excessive Amount of Blood / Fluid Transfusion
Intraoperative Cardiac Arrest During Cardiac Surgery
Critical Incident
Anesthesia
Failed Conscious Sedation During Procedure
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2011-07-11
Enrollment: 10000
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: Patients undergoing transcatheter aortic valve implantation (TAVI)

Brief summary: In modern cardiac surgery and cardiology Transcatheter Aortic Valve Implantation (TAVI) is an emerging procedure for high-risk patients that are assumed to be otherwise inoperable. The investigators want to evaluate the specific intraoperative anesthesiologic characteristics cardiac anesthesiologists have to face during these procedures.


Eligibility criteria: Inclusion Criteria:

- Patients undergoing transcatheter aortic valve implantation (TAVI)

Exclusion Criteria:

- Refusal by patient

Primary outcomes:
measure: Perioperative Care
timeFrame: 1 day
Secondary outcomes:
measure: Up to 10 years
timeFrame: 10 Years
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum München, Department of Anaesthesiology, Technische Universität München
state: Bavaria
Study officials:
affiliation: Deutsches Herzzentrum München, Technische Universität München
name: Patrick N Mayr, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Deutsches Herzzentrum München, Technische Universität München
name: Michael Joner, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mayr NP, Wiesner G, van der Starre P, Hapfelmeier A, Goppel G, Kasel AM, Hengstenberg C, Husser O, Schunkert H, Tassani-Prell P. Dexmedetomidine versus propofol-opioid for sedation in transcatheter aortic valve implantation patients: a retrospective analysis of periprocedural gas exchange and hemodynamic support. Can J Anaesth. 2018 Jun;65(6):647-657. doi: 10.1007/s12630-018-1092-4. Epub 2018 Feb 20.
Clinical trial NCT01885975: Personality Profile of Patients With Apical Ballooning Syndrome
Official title: Personality Profile of Patients With Apical Ballooning Syndrome (ABS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apical Ballooning Syndrome
Keywords: Apical Ballooning syndrome
Personality
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 53
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: This study will be conducted among participants in the Mayo Clinic Apical Ballooning Registry. These patients were prospectively diagnosed with Apical Ballooning Syndrome at the time of presentation with their acute illness, and consented to participation in a registry. They are residents of Olmsted County, and the surrounding regions for which the Mayo Clinic serves as a tertiary care center. Enrollment in the registry requires satisfaction of standard criteria for the diagnosis of ABS and includes the administration of a standardized questionnaire. Subjects have agreed to participate in yearly follow up questionnaires about their health status.

Brief summary: The investigators' hypothesis is that patients with apical ballooning syndrome (ABS) will manifest a personality profile that differs than that of a population of similar range of ethnic and socioeconomic status.


Eligibility criteria: Inclusion criteria:

1. Patients who have suffered with ABS
2. Adults (18 years or older)
3. Able to read English at a 6th grade level (questionnaires are self-administered and written in English)

Exclusion criteria:

1. Have withdrawn from the registry
2. Have died

Primary outcomes:
measure: Range of personality traits as assessed by the "NEO-PI-3"
timeFrame: Baseline: the traits will be assessed once upon enrollment into the study
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Abhiram Prasad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03539575: CB1R in Synthetic Psychoactive Cannabinoids
Official title: CB1R Availability in Synthetic Psychoactive Cannabinoid Users
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Drug Dependence
Keywords: K2
Spice
Synthetic Marijuana
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Drug Abuse (NIDA)
First posted: 2018-05-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this research study is to determine whether the CB1R availability is lower in synthetic psychoactive cannabinoid subjects using the most widely available synthetic psychoactive cannabinoids at the time the study is initiated.


Eligibility criteria: Inclusion:

* Able to provide written consent
* Age 18-55
* Current Synthetic Psychoactive Cannabinoids consumption

Exclusion:

* MRI metal exclusions and claustrophobia
* Education completed is less than 12 years

Primary outcomes:
measure: Positron Emission Tomography (PET Imaging)
timeFrame: Change in CB1R availability from baseline throughout one test day
Secondary outcomes:
measure: CogState Battery
timeFrame: Change in CB1R availability from baseline throughout one test day
measure: Electroencephalogram
timeFrame: Change in CB1R availability from baseline throughout one test day
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Deepak C D'Souza, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Mohini Ranganathan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01729975: Comparative Study of Specular Microscope for Cell Density, Coefficient of Variation, Hexagonality and Corneal Thickness
Official title: Comparative Study of Specular Microscopes for the Measurement of Endothelial Cell Densities, Coefficient of Variation of Endothelial Cell Area, ％Hexagonality, and Central Corneal Thickness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corneal and Endothelial Cell Measurements
Lead sponsor: Nidek Co. LTD.
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ophthalmology Practice

Brief summary: The primary objective of this clinical study is to collect clinical data to support an FDA 510(k) submission for the Nidek Specular Microscope CEM-530. The secondary objective is to evaluate any adverse events found during the clinical study.


Eligibility criteria: Inclusion Criteria:

* Non-Pathologic: Male or female subjects from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who follow the instructions by Principal/Clinical investigator or clinical staff at the clinical site, and can visit on a scheduled examination date.
* Pathologic: Male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who follow the instructions by Principal/Clinical investigator or clinical staff at the clinical site, and can visit on a scheduled examination date and subjects who have any of the following conditions:

  * History of Post-op surgical trauma including, Psudophakic or Aphakic blous keratopathy or glaucoma surgery
  * History of corneal transplant
  * Physical injury or trauma to the cornea
  * Long term Fuch's dystrophy/Guttata (and other corneal endothelial dystrophy)
  * Keratoconus
  * Long term PMMA contact lens use

Exclusion Criteria:

* Non-Pathologic subjects who have the following conditions:

  * Long term Diabetes
  * Dementia
  * Subjects who have other life threatening and/or debilitating systemic diseases
  * History of corneal transplant
  * Long term Fuch's dystrophy (and other corneal endothelial dystrophy)
  * Keratoconus
  * Guttata
  * Diabetic retinopathy
  * History of cataract or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device.
  * All contact lens wearers
* Pathologic subjects who have Dementia or who have other life threatening and/or debilitating systemic diseases

Primary outcomes:
measure: Corneal and Endothelial Cell Measurements
timeFrame: single time point - 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
References: