louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01360619: Clinical Study About Fat Measurement on Multifunction Keito by Comparison Versus Its Predicate K014009
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Body Fat
Keywords: To demonstrate that multifunction Keito is as effective, as safe and accurate as the predicate K014009 on its body fat measurement.
Lead sponsor: Aguiflai Iberica, S.L.
Sponsor class: INDUSTRY
First posted: 2011-05-25
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 82
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: To include the maximum types of patients, the selection was opened to all the general public who could use the multifunction Keito in a public site, where is is intended to be placed. The test was carried out following the user's manual rules about who can use the device.

Brief summary: The researchers believe that the multifunction Keito devices shares with TANITA TBF-300 (K014009) the same efficacy on the body fat measurement. Even if the body contact points are not the same, the researchers deeply believe that the tetrapolar BIA used by the predicate gives results as similar as the multifunction keito does.

Detailed description: 177 volunteers were enrolled in this clinical Study. Before taking the fat measurement by the devices under test, the observers measured the weight and height of each volunteer prior to measure the body fat. This was done to configure a preliminary idea about the body composition of the subject.

Both devices are designed by the same technology to emit a low current through the body, and finally make a measurement of the impedance found between the body contact points. We expected the results to be very similar.

Eligibility criteria: Inclusion Criteria:

* All population who meet with the requirements described on the user's manual.

Exclusion Criteria:

* Pregnant women.
* Individuals who have a pacemaker or any other internal medical device.
* Population whose weight is under 15 Kg and less than 135 cm tall.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vilassar de Mar
country: Spain
facility: Aguiflai Iberica, s.l
state: Barcelona
Study officials:
affiliation: Aguiflai Iberica, S.L.
name: Angel P Ferre, Telecommunications Engineer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03857919: TearCare System to Treat Dry Eye Disease
Official title: Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare® System in the Treatment of the Signs and Symptoms of Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dry Eye
Meibomian Gland Dysfunction
Lead sponsor: Sight Sciences, Inc.
Sponsor class: INDUSTRY
First posted: 2019-02-28
Enrollment: 138
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the TearCare System will be compared with the LipiFlow Thermal Pulsation System in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease.

NOTE: All sites have been selected for this study. We are not seeking additional sites at this time.


Eligibility criteria: Key Inclusion Criteria:

* At least 22
* Subject has dry eye symptoms and uses artificial tears/lubricants regularly
* Subject has moderate to severe symptoms based on a dry eye questionnaire
* Subject has an abnormal tear break-up time
* Subject's eyelid glands secrete a low amount of meibum
* Best corrected visual acuity 20/100 or better
* Willing and able to comply with protocol
* Willing and able to provide consent
* English-speaking

Key Exclusion Criteria:

* Use of medications that treat dry eye disease or that are known to cause ocular dryness.
* Use of topical ophthalmic antibiotics, anti-glaucoma medications, steroids, NSAIDs
* Prior office-based dry eye treatment within the past 12 months, gland expression within the past 6 months, debridement within the past 3 months, punctal plus within 30 days, TrueTear within the past 2 weeks, or meibomian gland probing.
* History of eyelid, conjunctival or corneal surgery within the past year.
* Contact lens use within past 2 weeks
* Ocular conditions or diseases that could limit the safety or effectiveness of the study treatment.

Primary outcomes:
measure: Tear Break-Up Time
timeFrame: 1 month
measure: Meibomian Gland Secretion Score
timeFrame: 1 month
Secondary outcomes:
measure: Ocular Surface Disease Index (OSDI)
timeFrame: 1 month
measure: Corneal staining score
timeFrame: 1 month
measure: Conjunctival staining score
timeFrame: 1 month
measure: SANDE
timeFrame: 1 month
measure: Eye Dryness Score
timeFrame: 1 month
measure: Meibomian glands yielding clear secretions
timeFrame: 1 month
measure: Meibomian glands yielding clear or cloudy secretions
timeFrame: 1 month
Other outcomes:
Locations:
city: Miami
country: United States
facility: Center for Excellence in Eye Care
state: Florida
Study officials:
References:
citation: Holland EJ, Loh J, Bloomenstein M, Thompson V, Wirta D, Dhamdhere K. A Comparison of TearCare and Lipiflow Systems in Reducing Dry Eye Disease Symptoms Associated with Meibomian Gland Disease. Clin Ophthalmol. 2022 Aug 30;16:2861-2871. doi: 10.2147/OPTH.S368319. eCollection 2022.
Clinical trial NCT04491019: Comparison of the Effects of Two Different Exercise Programs in Obese Adolescents
Official title: Comparison of the Effects of Two Different Exercise Programs on Balance, Posture and Lower Extremity Functions in Obese Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity, Adolescent
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Obesity is one of the most important health problems of developed and developing countries. Especially in children and adolescents, the prevalence of obesity is increasing at an alarming rate. In obese individuals, the effects of postural control and balance have been reported to cause musculoskeletal problems, and motor control skills have been found to decrease. The aim of this study is to compare the effects of balance exercises and strengthening exercises on balance, posture and lower extremity functions in obese adolescents.


Eligibility criteria: Inclusion Criteria:

* Individuals aged 12-18 Body Mass Index to be 95 and above according to percentile values No exercise program in the past 6 months

Exclusion Criteria:

* Having a medical condition that prevents exercise Having a disease of neuromuscular origin Presence of psychiatric or neurological diseases affecting cooperative and cognitive functions Equilibrium effect due to another disease

Primary outcomes:
measure: The six-minute walking test
timeFrame: Change from baseline to 8 weeks, follow up at two months
Secondary outcomes:
measure: Sit Up Stand Test
timeFrame: Change from baseline to 8 weeks, follow up at two months
measure: Evaluation of Muscle Force
timeFrame: Change from baseline to 8 weeks, follow up at two months
measure: 10 Step Down Time Test
timeFrame: Change from baseline to 8 weeks, follow up at two months
measure: Functional Forward Reach Test
timeFrame: Change from baseline to 8 weeks, follow up at two months
measure: Flamingo Balance Test
timeFrame: Change from baseline to 8 weeks, follow up at two months
measure: One Leg Stand Test
timeFrame: Change from baseline to 8 weeks, follow up at two months
measure: Bioelectrical Impedance Analysis
timeFrame: Change from baseline to 8 weeks, follow up at two months
measure: PostureScreen Mobile
timeFrame: Change from baseline to 8 weeks, follow up at two months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
References:
Clinical trial NCT04933019: Detection of Clindamycin Resistance Antibiotic Genes Among Staphylococcus Isolates by Using Real Time PCR
Official title: Detection of Clindamycin Resistance Antibiotic Genes Among Staphylococcus Isolates by Using Real Time PCR
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Staphylococcus Isolates
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR

Detailed description: Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR

Eligibility criteria: Inclusion Criteria:

* all staphylococcus isolates resistant to clindamycin

Exclusion Criteria:

* non

Primary outcomes:
measure: Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Egypt
Study officials:
References:
Clinical trial NCT06693219: Accuracy of Ultrasonography in Confirming Correct Positioning of Nasogastric Tube in the Intensive Care Setting
Official title: Accuracy of Ultrasonography in Confirming Correct Positioning of Nasogastric Tube in the Intensive Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasogastric Tube Placement
Accuracy
Ultrasonography
Critical Care, Intensive Care
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2024-11-18
Enrollment: 182
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 goal of the study was to test whether a sonographic examination instead of an X-ray allows the position of a tube in the stomach to be checked.

Participants were patients admitted at an intensive care unit who required a nasogastric tube for several reasons (for example nutrition). After obtaining an informed consent from the patient or the family, the researchers checked the position of the tube with ultrasound and compared it with the gold standard, which is radiography. Data analysis allowed the concordance between the two tests to be analyzed.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* an already inserted nasogastric tube or required nasogastric tube insertion
* no contraindication for chest or abdominal X-ray
* no contraindication for neck and upper abdominal ultrasonography

Exclusion Criteria:

* pregnancy
* basal skull fractures
* facial fractures
* previous or recent surgery of the neck, esophagus or stomach

Primary outcomes:
measure: Diagnostic accuracy of ultrasonography in determining correct nasogastric tube placement in the stomach
timeFrame: Through study completion (enrollment of approximately 180 patients)
Secondary outcomes:
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Medicina Intensiva, Ente ospedaliero cantonale
Study officials:
References:
Clinical trial NCT01433419: Open-label Study of TAK-875
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-09-14
Enrollment: 333
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the safety and efficacy of treatment with TAK-875 in diabetic patients.


Eligibility criteria: Inclusion Criteria:

1. The participant is an outpatient.
2. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

1. The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
2. The participant is considered ineligible for the study for any other reason by the investigator or sub-investigator.

Primary outcomes:
measure: Adverse events
Secondary outcomes:
Other outcomes:
Locations:
city: Katori-shi
country: Japan
state: Chiba
city: Niihama-shi
country: Japan
state: Ehime
city: Chikushino-shi
country: Japan
state: Fukuoka
city: Fukuoka-shi
country: Japan
state: Fukuoka
city: Onga-gun
country: Japan
state: Fukuoka
city: Yukuhashi-shi
country: Japan
state: Fukuoka
city: Hiroshima-shi
country: Japan
state: Hiroshima
city: Chitose-shi
country: Japan
state: Hokkaido
city: Sapporo-shi
country: Japan
state: Hokkaido
city: Koga-shi
country: Japan
state: Ibaragi
city: Ushiku-shi
country: Japan
state: Ibaragi
city: Chigasaki-shi
country: Japan
state: Kanagawa
city: Kamakura-shi
country: Japan
state: Kanagawa
city: Minamata-shi
country: Japan
state: Kumamoto
city: Yatsushiro-shi
country: Japan
state: Kumamoto
city: Sasebo-shi
country: Japan
state: Nagasaki
city: Kashihara-shi
country: Japan
state: Nara
city: Okinawa-shi
country: Japan
state: Okinawa
city: Izumi-shi
country: Japan
state: Osaka
city: Suita-shi
country: Japan
state: Osaka
city: Fujimi-shi
country: Japan
state: Saitama
city: Shimotsuga-gun
country: Japan
state: Tochigi
city: Komatsushima-shi
country: Japan
state: Tokushima
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Chiyoda-ku
country: Japan
state: Tokyo
city: Mitaka-shi
country: Japan
state: Tokyo
city: Shibuya-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Toshima-ku
country: Japan
state: Tokyo
city: Shunan-shi
country: Japan
state: Yamaguchi
city: Ube-shi
country: Japan
state: Yamaguchi
Study officials:
References:
Clinical trial NCT02895919: Bedside Inoculation of Ascitic Fluid in Diagnostic Paracentesis
Official title: Is Bedside Inoculation of Ascitic Fluid in Diagnostic Paracentesis Associated With a Higher Sensitivity for Positive Cultures? Prospective Observational Trial
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ascites
Peritonitis
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2016-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient population will include all patients undergoing diagnostic paracentesis comparing standard culture protocol (bedside inoculation of blood culture bottles with ascitic fluid) with an additional culture collected for study arm. Patients will be all comers for diagnostic paracentesis.

Brief summary: This study seeks to determine non inferiority of direct inoculation of ascitic fluid in lab as compared to current culture media standard, bedside inoculation with blood culture bottles.

Detailed description: The purpose of this study is to validate the principal study that recommends inoculation with blood culture bottles at bedside versus lab inoculation (delayed inoculation) of ascitic fluid in the diagnosis of spontaneous bacterial peritonitis. This study had a small sample size (29) and goal is to validate results with a larger sample size. The aim of current proposed study is to assess for non inferiority of lab inoculation of ascitic fluid culture versus current standard of blood culture bottles. To achieve 90% power and true sensitivity 95%, goal is to enroll 460 patients within the course of a year or until number of samples is reached, with plan to compare the sensitivity of bedside inoculation of blood culture bottles versus the lab using sterile plate techniques as per current lab culture technique. Unlike previous study, all comers for ascitic fluid collected will be analyzed that are to undergo diagnostic paracentesis.

Eligibility criteria: Inclusion Criteria:

* Ascites on ultrasound

Exclusion Criteria:

* Consent declined

Primary outcomes:
measure: Growth of bacteria on ascitic fluid culture
timeFrame: through study completion, an average of 1 year to complete enrollment of 460 patients
Secondary outcomes:
measure: Time to positive ascitic fluid culture
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Medical College of Wisconsin
name: Ricardo Franco Sadud, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01937819: Patients Judging Bowel Preparation by Using SMARTPHONE Application
Official title: Patients Judging Dose Adjustment of Bowel Preparation Solution for Bowel Preparation by Using SMARTPHONE Application: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: BOWEL PREPARATION (BOWEL CLEANSING)
Keywords: BOWEL PREPARATION
SMARTPHONE APPLICATION
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2013-09-10
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: High-quality bowel preparation is a prerequisite for colonoscopy. Few studies have evaluated visual aids as a means of improving the quality of bowel preparation. We assess the effect of patient-judging dose adjustment of bowel preparation solution for bowel preparation using SMARTPHONE application on the quality of bowel preparation.

Detailed description: This was a randomized, prospective, endoscopist-blinded clinical trial in which the efficacy of SMARTPHONE application on the bowel cleansing was inspected.

A intervention patients take the picture of stool using SMARTPHONE camera application, and then assess the bowel cleansing result. If the result is "Pass", they stop the addition of bowel preparation agent. but the result is "Fail", so they have the additive bowel preparation agent and repeat using the SMARTPHONE application.

After the bowel preparation, Endoscopists, who were blinded to the study group of the patient, immediately completed the Ottawa scale after procedure.

Eligibility criteria: Inclusion Criteria:

* Patient who are scheduled for colonoscopy Available to use the SMARTPHONE application and smartphone camera

Exclusion Criteria:

* known or suspected bowel obstruction known pregnancy, breast feeding known allergy to PEG presence of severe illness(renal failure, congestive heart failure, liver failure,), refusal of consent to participate in the study not available to use the SMARTPHONE application and SMARTPHONE camera

Primary outcomes:
measure: bowel cleaning quality according to Ottawa scale scores
timeFrame: 3 months
Secondary outcomes:
measure: The consistency of bowel cleansing result by SMARTPHONE application with Ottawa scale scores by colonoscopy
timeFrame: 3 months
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Haeundae Paik Hospital
Study officials:
References:
Clinical trial NCT01905319: Juvenile Idiopathic Arthritis in Children in Estonia.
Official title: Juvenile Idiopathic Arthritis in Children in Estonia - an Epidemiological and Clinical Investigation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epidemiology
Keywords: juvenile idiopathic arthritis
incidence rate
Lead sponsor: University of Tartu
Sponsor class: OTHER
First posted: 2013-07-23
Enrollment: 162
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: During years 1998-2000, 162 newly-diagnosed juvenile idiopathic arthritis cases from 14 counties of Estonia, were included to the study, among them 76 boys and 86 girls.

Brief summary: Aims of the study:

* to study the incidence rate of juvenile idiopathic arthritis (JIA) and it's clinical subtypes in Estonia for the years 1998-2000;
* to examine the course and short-term clinical outcome of JIA.

Method: a prospective population-based study carried on in 14 counties of Estonia


Eligibility criteria: Inclusion Criteria:

* The International League of Associations for Rheumatology (ILAR) criteria for juvenile idiopathic arthritis
* children aged 0-15 years who had arthritis of an unknown cause for at least six weeks with an onset of the disease during the study period

Exclusion Criteria:

* Children with infectious arthritis, postinfectious arthritis, traumatic arthritis and systemic connective tissue diseases

Primary outcomes:
measure: Mean annual incidence rate of juvenile idiopathic arthritis in Estonia during years 1998-2000.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Pullerits R, Schierbeck H, Uibo K, Liivamagi H, Tarraste S, Talvik T, Sundberg E, Pruunsild C. High mobility group box protein 1-A prognostic marker for structural joint damage in 10-year follow-up of patients with juvenile idiopathic arthritis. Semin Arthritis Rheum. 2017 Feb;46(4):444-450. doi: 10.1016/j.semarthrit.2016.08.017. Epub 2016 Aug 26.