louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00335101: Renal Effects of Three Iodinated Contrast Media (CM) in Patients at Risk Undergoing Coronary Angiography
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Coronary Artery Disease (CAD)
Renal Impairment
Diabetes Mellitus
Keywords: Coronary Artery Disease (CAD), Renal Impairment, Serum creatinine (SCr), Iodixanol, Ioversol, Iopromide, Contrast Induced Nephropathy (CIN)
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2006-06-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The study is to evaluate and compare the effects on kidney function of three iodinated contrast media (CM) in patients at risk of kidney damage evaluating serum creatinine (Scr) concentrations up to three days after CM administration.


Eligibility criteria: Inclusion Criteria:

* Subjects with a combination of DM (type I or II) and renal impairment (RI), defined as SCr ≥150 µmol/L (1.7 mg/dL) for men and ≥133 µmol/L (1.5 mg/dL) for women or creatinine clearance (CrCl) ≤50 mL/min calculated according to Cockroft-Gault formula, referred for coronary angiography with or without PCI.

Exclusion Criteria:

* Concurrent administration of potentially nephroprotective or nephrotoxic drugs is not allowed. Subjects undergoing dialysis or kidney transplantation or with CrCl \< 20 mL/min will not be included.

Primary outcomes:
measure: Primary endpoint:
measure: Maximum peak increase in SCr from baseline up to day 3.
measure: Secondary endpoints:
measure: Change in SCr from baseline to day 2 and to day 3
measure: Number of subjects with contrast-induced nephropathy (CIN)
measure: Quality of diagnostic information
Secondary outcomes:
measure: Coronary Artery Disease (CAD)
measure: Renal Impairment
measure: Diabetes mellitus
Other outcomes:
Locations:
city: Princeton
country: United States
facility: GE Healthcare
state: New Jersey
city: Munich
country: Germany
facility: GE Healthcare
Study officials:
affiliation: GE Healthcare
name: Marc Pignot, PhD
role: STUDY_DIRECTOR
affiliation: GE Healthcare
name: Johnny Gibbs, Jr., CCRA
role: STUDY_DIRECTOR
References:
Clinical trial NCT04968301: Cross-sectional Study of Ultrasonic Diagnosis of Iliac Joint Capsule Muscle
Official title: A Cross-sectional Study: the Development of the Hip Joint Was Studied by Measuring the Anatomical Circumference of the Capsular Muscle of the Iliac Joint With Ultrasound Doppler
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoroacetabular Impingement
Hip Developmental Dysplasia
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 132
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were admitted to the sports medicine outpatient department of Peking University Third Hospital for hip surgery and volunteers recruited as control group，including 40 patients with developmental dysplasia of the hip 40 femoroacetabular impingement patients and 40 healthy volunteers as the control group.

Brief summary: In order to investigate the relationship between the iliac joint capsular muscle and the development of the hip joint, this study used ultrasound Doppler to measure the anatomical circumference of the iliac joint capsular muscle to explore the relationship

Detailed description: In order to investigate the relationship between the iliac joint capsular muscle and the development of the hip joint, this study used ultrasound Doppler to measure the anatomical circumference of the iliac joint capsular muscle to explore the relationship.Ultrasound was used to compare the size of the iliac joint cystic muscle in the three groups: patients with developmental dysplasia of the hip (DDH), patients with Pincer type femoral hip impingement, and normal control group. The shear wave velocity and shear modulus of the iliac joint capsular muscle of three groups were compared to compare the degree of fat infiltration in muscle.

Eligibility criteria: Inclusion Criteria:

* ≥ 20 years;
* Clinically suspected of DDH or Pincer and underwent surgery
* Understand and sign the informed consent

Exclusion Criteria:

* Leggcalve´-Perthes disease
* Muscle diseases
* Hip development disorder
* History of progressive osteoarthritis
* History of hip surgery
* History of arthritis of the hip joint
* With pacemaker or metal in the body

Primary outcomes:
measure: Parameter of ultraphonic results
timeFrame: Ultraphonic was conducted when patients were included in the study from March to October, 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Ultrasound Diagnosis, Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Ligang Cui
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04283201: Type 2 Diabetes Mellitus Prevention Ukraine
Official title: Development, Implementation and Evaluation of the Effectiveness of Recommendations for the Prevention of Type 2 Diabetes in Ukraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Impaired Fasting Glucose
Impaired Glucose Tolerance
Type 2 Diabetes
Keywords: lifestyle modification
type 2 diabetes
prevention
Ukraine
Rural
Lead sponsor: Komisarenko Institute of Endocrinology and Metobolism
Sponsor class: OTHER_GOV
First posted: 2020-02-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 30 persons from this category were additionally advised to consume insoluble dietary fiber 15 g per day (Vitacel wheat fiber) for 3 months, after which a repeat anthropometric and biochemical study.
Primary purpose: PREVENTION

Brief summary: Development, implementation and evaluation of the effectiveness of lifestyle recommendations for the prevention of type 2 diabetes in rural population of Ukraine

Detailed description: An oral glucose tolerance test and anthropometric measurements were performed for 300 randomly selected rural residents of the Kyiv region of Ukraine. Persons from impaired glucose regulation category (impaired fasting glucose - IFG) was enrolled to diabetes prevention intervention study (T2DPUA).

Individuals in the IFG category received advice on limiting sugar intake (not more than 25 g per day), increasing physical activity (30 minutes daily). 30 persons from this category were additionally advised to consume insoluble dietary fiber 15 g per day (Vitacel wheat fiber) for 3 months, after which a repeat anthropometric and biochemical study. Objective control of physical activity and body composition is also provided.

Eligibility criteria: Inclusion Criteria:

Persons with fasting blood glucose level \>=6.1 mmol/l; persons aged 18-79 who signed an informed consent for the study.

Exclusion Criteria:

Known diabetes; acute infectious diseases; other serious diseases

Primary outcomes:
measure: New type 2 diabetes cases
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: V.P.Komisarenko Institute of Endocrinology and Metabolism
Study officials:
affiliation: V.P.Komisarenko Institute of Endocrinology and Metabolism
name: Victor Kravchenko, PhD, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT00779701: Strict Glycemic Control by Insulin Infusion:Observations on Emergency Department Initiation
Official title: Strict Glycemic Control by Insulin Infusion:Observations on Emergency Department Initiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperglycemia
Keywords: Hyperglycemia
Glycemic control
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2008-10-24
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Glycemic control can be safely achieved in surgical and medical intensive care unit settings and has been shown to improve short and long-term clinical outcomes. As such, insulin infusion protocols are routinely used in the ICU setting. The investigators plan to establish the use of strict glycemic control in a heterogenous group of acutely ill patients in the ED setting. The investigators propose to study the aspects of implementing a strict glycemic control protocol in the ED.


Eligibility criteria: Inclusion Criteria:

* Patients with blood glucose ≥130 mg% considered to be critically ill as defined by:

APACHE II score ≥9 (See Appendix 1) OR \>2 SIRS criteria with lactate ≥ 4 or BP \< 90mmHg despite one liter of fluid OR Evidence of Organ Dysfunction (see Appendix 1)

Exclusion Criteria:

* Patients requiring urgent interventional procedure (e.g. cardiac catheterization, dialysis) or surgery performed outside of the ED.

Primary outcomes:
measure: Time to Achieve Glycemic Control
timeFrame: Study duration 6 hours. Blood glucose checked at 30 minutes then every 15 minutes until within target blood glucose range then every hour.
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Nina T Gentile, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00131001: CARMEDAS: Cost-Effectiveness Analysis of Imaging Strategies in Symptomatic Carotid Stenosis
Official title: Cost-Effectiveness Analysis of Imaging Strategies in Symptomatic Carotid Stenosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carotid Stenosis
Keywords: Carotid artery stenosis
cost effectiveness
magnetic resonance angiography
computed tomography angiography
digital subtraction angiography
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2005-08-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: PURPOSE: The purpose of this clinical trial is to study the cost-effectiveness ratios of diagnostic strategies for the imaging assessment of symptomatic carotid stenosis.

MATERIALS AND METHODS: The diagnostic accuracies of Doppler ultrasound (DUS), contrast-enhanced magnetic resonance angiography (CEMRA) and computed tomography angiography (CTA) were compared with digital subtraction angiography (DSA) in a multicenter study (CARMEDAS; 206 patients assessable) and in a meta-analysis (for CEMRA and CTA). The direct costs of each imaging method were calculated in 2 university medical centers. Eight hypothetical models were studied with DUS considered as the first-line imaging method and either CEMRA or CTA or DSA as the second or third line method. The effectiveness criterion was the number of potential avoided strokes for each strategy and for 1000 patients.


Eligibility criteria: Inclusion Criteria:

Carotid artery stenosis \> 50%

Primary outcomes:
measure: To study the cost-effectiveness ratios of diagnostic strategies for the imaging assessment of symptomatic carotid stenosis
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Louis Pradel
Study officials:
affiliation: Hospices Civils de Lyon
name: Philippe DOUEK, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00235001: Russian Study of the Efficacy and Safety of Tarka in Patients With Hypertension
Official title: A Multicenter, Open, Phase IV, 24-Hour Ambulatory Blood Pressure Monitoring Study of the Efficacy and Safety of Tarka in Patients With Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
Tarka
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-10-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate antihypertensive activity and safety profile of Tarka in Russian hypertension patients by ambulatory blood pressure measurement (ABPM)


Eligibility criteria: Inclusion Criteria:

* Hypertension

Exclusion Criteria:

* SBP \> 180 mm Hg, DBP \> 114 mm Hg
* Subject has a hypersensitivity to trandolapril or verapamil

Primary outcomes:
measure: Change in blood pressure from baseline/blood pressure control
timeFrame: Baseline to 3 months of Tx
Secondary outcomes:
measure: Absolute BP reduction from baseline, safety
timeFrame: Baseline to 3 months of Tx
Other outcomes:
Locations:
city: North Chicago
country: United States
facility: Global Medical Information-Abbott
state: Illinois
Study officials:
affiliation: Abbott
name: Victor Gorin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03149601: Composition and Collection Feasibility of Gut Microbiota in Children With and Without Obesity
Official title: Composition and Collection Feasibility of Gut Microbiota in Children With and Without Obesity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Childhood Obesity
Lead sponsor: University of Illinois College of Medicine at Peoria
Sponsor class: OTHER
First posted: 2017-05-11
Enrollment: 150
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 150 participants will be recruited from 4 primary care sites (2 urban and two rural) and a tertiary pediatric weight management clinic (PWMC) located in Central Illinois over an 18 month period. Enrollment will equally represent urban and rural lean participant living environments.

Brief summary: Adults with obesity have an imbalance of bacteria in their intestines which may contribute to weight gain and diseases related to obesity. Restoring the balance of these bacteria (the "microbiota") could help reduce weight and related diseases. However, little is known about this imbalance in children with obesity. This research study will map out the compositions of the gut microbiota of children and compare them with those of children who have healthy weights and different degrees of obesity. This project will also measure the amounts of fatty acids in the stools which are an indication of how efficiently the intestines absorb calories from food. If an imbalance is detected in children with obesity, then this information can help researchers test ways to restore the gut microbiota with hopes of reducing weight and some of its related health problems.


Eligibility criteria: Inclusion Criteria:

1) patients aged 5-12 years

Exclusion Criteria:

1. patient who have received either oral or parenteral antibiotics in the last 3 months
2. patients who have a diagnosed immunodeficiency
3. patients who are on medications that modulate the immune system including systemic prednisone and biologics
4. patients who have a gastrointestinal condition which is known to alter the gut flora such as inflammatory bowel disease, chronic diarrhea, celiac disease and eosinophilic gastroenteritis diseases
5. patients who have taken proton pump inhibitors in the last 3 months
6. patients who have taken probiotics in the last 6 months.

Primary outcomes:
measure: Microbiota Composition
timeFrame: Over 2 years
measure: Short Chain Fatty Acid Content
timeFrame: Over 2 years
measure: Specimen Quality
timeFrame: Over 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Peoria
country: United States
facility: University of Illinois College of Medicine at Peoria
state: Illinois
Study officials:
References:
Clinical trial NCT00339001: Erythropoietin and Early Iron Supplement and Retinopathy of Prematurity
Official title: The Possible Influence of Erythropoietin and Early Iron Supplements on the Prevalence and Severity of Retinopathy of Prematurity and Other Short Term Outcome of Prematurity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Retinopathy of Prematurity
Keywords: Erythropoietin
Iron
Retinopathy of prematurity
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2006-06-20
Enrollment: 400
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: To evaluate the possibility that erythropoietin with early iron supplementation may induce retinopathy of prematurity or worsen this disease. In addition risk factors for the development of ROP will be checked.


Eligibility criteria: Inclusion Criteria:

* all premature infants with birth weight of 1250 grams or less

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Neonatal Department, Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Jacob Kuint, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03681301: Development and Impact Assessment of Virtual Reality Simulator on the Education of the Endotracheal Intubation in the Medical Students
Official title: Development and Impact Assessment of Virtual Reality Simulator on the Education of the Endotracheal Intubation in the Medical Students
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Medical Education
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: OTHER

Brief summary: The medical school educates students on essential skills, which is an important task. Especially, endotracheal intubation is considered an important option in the management of cardiopulmonary resuscitation.

To avoid technical and ethical concerns of training involving real patients, conventional teaching methods incorporate the use of a low-fidelity manikin in replacement. However, the manikin anatomy often lacks the realism of a live human.

The addition of virtual reality technology may optimize learning by providing an ethical, cost-effective and more realistic modality to acquire the basic skills of intubation. If it is proven to be effective, efforts to integrate virtual reality technology into routine training of such procedures in the medical school should be promoted.

The investigators hypothesize that the addition of virtual reality mobile application to conventional training will improve procedural skill dexterity and proficiency and hence, improve learner's satisfaction and confidence in performing endotracheal intubation.


Eligibility criteria: Participants included medical school students without intubation intubation experience

Primary outcomes:
measure: Total score of required 20-key points of intubation during endotracheal intubation procedure
timeFrame: within 1 month after training session
Secondary outcomes:
measure: Intubation complete time (secs)
timeFrame: within 1 months after training session
measure: Overall proficiency grading (fail/ pass/ high pass/ honors)
timeFrame: within 1 months after training session
measure: Overall confidence, anxiety, comfort level: 5-point Likert scale (1 = very low, 2 = low, 3 = moderate, 4 = high, 5 = very high)
timeFrame: within 1 months after training session
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT02757001: Inferior Vena Cava Retrievable Filters: Spanish Register
Official title: Inferior Vena Cava Retrievable Filters: Spanish Register (REFiVeC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vena Cava Filters
Keywords: Retrievable Inferior Vena Cava Filters
Pulmonary Embolism
Lead sponsor: Group of Research in Minimally Invasive Techniques
Sponsor class: OTHER
Collaborators: name: SERVEI (Sociedad Española de Radiología Vascular e Intervencionista)
First posted: 2016-04-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in whom a vena cava filter has been implanted with intention of being retrieved (non-permanent).

Brief summary: Spanish registry of retrievable vena cava filters.

This registry is sponsored by the Spanish Society of Vascular and Interventional Radiology (SERVEI) and conducted by the Research Group GITMI (Group of Research in Minimally Invasive Techniques) of the University of Zaragoza (Spain).

A software tool hosted on the official website of SERVEI and the journal Intervencionismo will be used for data collection a(https://estudios.watsoncme.com).

Detailed description: This is an prospective observational study of patients that have been implanted a inferior vena cava filter with intention to be retrieved.

Patients are recruited when the filter is implanted, and the investigators observe when is it finally retrieved (dwell time), if retrieval is possible or not, and if there is any complication at the retrieval of the filter.

Eligibility criteria: Inclusion Criteria:

* Indicated inferior vena cava filter implantation
* Signed informed consent

Exclusion Criteria:

* Permanent filters (including retrievable filters intended to be used as permanent ones)
* Impossibility of follow-up (3, 6 and 12 months)
* Life expectancy less than a year
* Patient refusal to be included in the study, at any time

Primary outcomes:
measure: Success of retrieval
timeFrame: 12 months
Secondary outcomes:
measure: Dwell time
timeFrame: 12 months
measure: Complications in retrieval
timeFrame: 12 months
measure: Overall adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Vithas Nisa Pardo de Aravaca
city: Málaga
country: Spain
facility: Hospital Regional Carlos Haya
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
city: Zaragoza
country: Spain
facility: Lozano Blesa University Hospital
Study officials:
affiliation: Minimal Invasive Techniques Research Group
name: Miguel A De Gregorio, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: