louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01140243: Infant Formula Supplemented With a Special Fat Formulation for Premature Infants Following Discharge From Hospital
Official title: Efficacy and Suitability of Infant Formula With a Special Fat Formulation for Premature Infants Following Discharge From Hospital Following Discharge From Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infants
Keywords: fat formulation
Lead sponsor: Materna Laboratories
Sponsor class: INDUSTRY
First posted: 2010-06-09
Enrollment: 31
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and nutritional suitability of 2 infant formulas supplemented with different levels of LCPUFA, for premature infants following discharge from Hospital.


Eligibility criteria: Inclusion Criteria:

* premature infants of gestational age 32-34 weeks and AGA birth weight who are healthy at time of discharge.
* whose mothers are unable to breast feed or have chosen not to breast feed,
* Whose parents have signed the informed consent form.
* Only the first among twins will be recorded for the study.

Exclusion Criteria:

* Chromosomal abnormalities or congenital malformation.
* Metabolic abnormalities.
* Central nervous system abnormalities.
* Severe developmental disorders.
* GI problems, GI surgery, necrotizing enterocolitis (NEC), gastro-esophageal reflux disease (GERD) requiring nutritional intervention.
* Milk allergy or intolerance.
* Growth failure.
* Chronic disease

Primary outcomes:
measure: anthropometric
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Neonatal Intensive Care Unit, Barzilai Medical Center
city: Jerusalem
country: Israel
facility: Sharei Zedek MC
Study officials:
References:
Clinical trial NCT00323843: Retrograde Intrarenal Stone Surgery - A Method of Treating the ESWL Resistant Kidney Stone
Official title: RIRS - A Method of Treating the ESWL Resistant Kidney Stone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Kidney Stone
Ureteroscopy
Keywords: Kidney stone
ureteropyeloscopy
renal pelvic pressure
Lead sponsor: Fredericia Hosptial
Sponsor class: OTHER
First posted: 2006-05-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Is it possible to decrease the intrarenal pressure in the kidney during endoscopic management of kidney stone by topical administration of drugs? In order to secure fewer complications in ureteroscopic operations the pharmacological agent isoproterenol is tested on pigs and human to determine its potential of lowering intrarenal pressure.


Eligibility criteria: Inclusion Criteria:

* Indication for RIRS procedure
* Age \> 18 years
* Normotensive
* Capable of understanding information given

Exclusion Criteria:

* Previous myocardiac infarct
* Daily use of alpha- og beta- blocking medicine og calcium antagonists
* Use of NSAID the last 2 days
* Stone in the ureter
* Declared
* Known malignant disease in urinary tract
* Bladder disease
* Nephrostomies inserted
* JJ-catheters inserted
* Prisoners
* Pregnant
* Nursing mothers

Primary outcomes:
measure: Renal pelvic pressure
Secondary outcomes:
measure: Blood pressure
measure: Pulse
Other outcomes:
Locations:
city: Fredericia
country: Denmark
facility: Dpt. of Urology
state: Vejle Council
Study officials:
affiliation: Fredericia Hospital, Dpt. of Urology
name: Helene U Jung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03361943: NHANES 2003-2014 and Sugar-sweetened Beverages in Children
Official title: Analysis of National Health and Nutrition Examination Survey (NHANES) 2003-2014 Data to Evaluate Trends in Sugar-sweetened Beverage (SSB) Intakes in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sugar Sweetened Beverage Intakes in US Children
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2017-12-05
Enrollment: 17579
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 17,579 children aged 2-18 years in US NHANES dietary surveys from 2003-2014 with household socioeconomic data

Brief summary: The study uses data from the NHANES surveys to evaluate trends in SSB intakes among US children. The goal was to determine whether recent declines in intake may have been less marked in the more vulnerable groups with a persistently high burden of obesity, including race/ethnic minorities and low-income groups.

Detailed description: Recent studies suggest sugar-sweetened beverage (SSB) consumption has been declining among US children 2-18y. However, most studies focus on changes in mean intake and little is known about trends in the high SSB consumers who are most at risk of excess weight gain. There is also limited understanding of whether and how these changes over time may have influenced disparities in intake among vulnerable groups of children with persistently high levels of obesity, including children from low-income households, and several race-/ethnic minorities.

This analysis of six cycles of US National Health and Nutrition Examination Survey (NHANES) dietary surveillance data from 2003-2014 examined shifts over time in SSB intake at both the median and 90th percentile among US children. The study evaluated the extent to which disparities in intake of total SSBs, as well as major SSB subtypes (regular sodas, fruit drinks and other), may have persisted in vulnerable groups, for both median and "heavy" intake. The analysis presents data for three age groups: 2-5y, 6-11y and 12-18y by gender, and focus on three race-ethnic groups: Non-Hispanic White, Non-Hispanic Black, and Mexican-American. Household income is used as the primary socioeconomic status variable.

Eligibility criteria: Inclusion Criteria:

* All U.S. children aged 2-18y in US NHANES diet surveys from 2003-2014

Exclusion Criteria:

* missing socio-economic data: parental education or household income as a percentage of the Federal Poverty Level; n=1841
* missing or implausible dietary data, defined as: energy intake of zero kcal or more than four standard deviations beyond individual estimated energy requirements, or no report on whether data represents usual intake (more, same or less than usual); n=236

Primary outcomes:
measure: Sugar Sweetened Beverage Intake in Children
timeFrame: 2003-2014
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01590043: Identifying Saliva Markers in Inflammatory Bowel Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 160
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients identified with infalmmatory bowel disease

Brief summary: Under normal conditions intestinal mucosa presents a baseline "physiological inflammation" caused by a controlled immune response that eliminates offending dietary and microbial antigens. This inflammation disappears once the cause is eradicated. In case of inappropriate immunological response, the inflammation becomes chronic and harmful, resulting in anatomical and functional abnormalities, namely inflammatory bowel disease (IBD).

Although it is critical for the IBD patients to undergo early diagnosis and management before the development of severe complications, but as IBD has vague and non-pathognomonic clinical features, the clinician is usually mislead into late suspicion and detection of IBD.

Diagnosis traditionally depended on a combination of pathologic evaluation together with the histological, clinical, radiological, endoscopic, surgical, laboratory (serological) features. Recently, serological markers were identified and became of special interest as they do not only detect the occurrence of IBD but also the potential of its development and may be used as prognostic tools. More recently, stool markers were detected and used for diagnosis.

Up to now, the market is still lacking a definitive, simple and non-invasive diagnostic tool. Saliva can present an alternative form of body fluids that simplify diagnostic procedures.

Our hypothesis is that IBD patients have special salivary biomarkers that may be identified through salivary analysis, where later on a simple non-invasive test can be applied in the form of an easy-to-use kit, being available at the clinician's clinic for the establishment of an immediate and early diagnosis of the destructive inflammatory bowel disease.


Eligibility criteria: Inclusion Criteria:

* Identified with inflammatory bowel disease

Exclusion Criteria:

* medically compromised children
* congenital syndromes
* children on medication chronically or on the day of the examination
* children treated with radiotherapy or chemotherapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Moti Moskovitz, DMD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Eyal Shteyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palmon R, Brown SJ, Abreu MT. What is the role and significance of serum and stool biomarkers in the diagnosis of IBD? Inflamm Bowel Dis. 2008 Oct;14 Suppl 2:S187-9. doi: 10.1002/ibd.20714.
Clinical trial NCT05301543: Insomnia Behavioral Intervention Study
Official title: Behavioral Intervention to Reduce Sedative Use in Older Adults With Chronic Insomnia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Insomnia
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized pilot study (n=20) explores the effects of a behavioral intervention, that includes sleep hygiene improvements, in long-term users of sleeping pills, aiming to alleviate or stabilize symptoms of insomnia, monitor and decrease sleeping pill usage. Adherence will be monitored by an optional smartphone application.

Detailed description: This randomized pilot study has a goal of enrolling 20 study participants. The investigators will examine the effects of a behavioral intervention, that includes sleep hygiene improvements such as regular sleep schedules, with assisted coaching support from the research team. Study participants are long-term users of sleeping pills. The goal is to improve or stabilizie insomnia symptoms and decrease sleeping pill usage. Study participant adherence will be monitored by an optional smartphone application.

Eligibility criteria: Inclusion Criteria:

* Age of 55-85
* Use of sleeping pill medication for sleep at least 3 nights a week
* Diagnosed with Chronic Insomnia by a physician
* Speaks English above a 6th-grade level
* Has access to a smartphone and/or smart tablet and can use it
* Has regular access to internet

Exclusion Criteria:

* Presence of major depression or other severe psychopathology (e.g., bipolar disorder, psychosis, alcohol/substance abuse, etc.)
* Presence of an acute or severe medical condition which, in the opinion of the research team, would interfere with the study participant's ability to participate in the research study, such as an acute heart attack, recent severe trauma, etc.

Primary outcomes:
measure: Sleep Pill Dosage
timeFrame: 28-day follow-up
Secondary outcomes:
measure: Sleep Efficiency
timeFrame: 28-day follow-up
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Medicine
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05197543: AAA Rupture Risk Assessment in COVID-19 Pandemic
Official title: Biomechanical Rupture Risk Assessment in Management of Patients With Abdominal Aortic Aneurysm in COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abdominal Aortic Aneurysm
COVID-19
Keywords: Abdominal aortic Aneurysm
Biomechanics
Rupture risk
Predictability
COVID-19
Lead sponsor: Masaryk University
Sponsor class: OTHER
Collaborators: name: VSB - Technical University of Ostrava
First posted: 2022-01-19
Enrollment: 102
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with asymptomatic AAA during the COVID-19 pandemic period. During this period an elective surgeries had to be posponed and there was a need for auxiliary diagnostic method able to identify AAAs with high risk of rupture.

Brief summary: The acute phase of the COVID-19 pandemic requires a redefinition of healthcare system to increase the number of available intensive care units for COVID-19 patients. This leads to the postponing of elective surgeries including the treatment of abdominal aortic aneurysm (AAA). The probabilistic rupture risk index (PRRI) recently showed its advantage over the diameter criterion in AAA rupture risk assessment. Its major improvement is in increased specificity and yet has the same sensitivity as the maximal diameter criterion. The objective of this study was to test the clinical applicability of the PRRI diagnostic method in a quasi-prospective observational patient cohort study.


Eligibility criteria: Inclusion Criteria:

* presence of asymptomatic abdominal aortic aneurysm (AAA)
* regular CT angiography scans available

Exclusion Criteria:

* rupture of AAA

Primary outcomes:
measure: Test the clinical applicability of the BRRA method
timeFrame: 21 months
Secondary outcomes:
measure: Reduction of time required for AAA assessment
timeFrame: 21 months
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: St. Anne´s University Hospital in Brno
Study officials:
affiliation: Masaryk University
name: Robert Staffa, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00387543: Alpha Lipoic Acid for Burning Mouth
Official title: Review of Mayo Clinic Experience With Burning Mouth Syndrome - Use of Alpha Lipoic Acid
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burning Sore Mouth
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2006-10-13
Enrollment: 200
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: records of patients diagnosed with BMS in the Department of Dermatology between 1995 and 2005

Brief summary: Discussion and evaluation of patients with sore and burning mouth to determine whether alpha lipoic acid is helpful in managing their symptoms.


Eligibility criteria: Patients seen in the Department of Dermatology with diagnosis of burning mouth syndrome between 2000 and 2005

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Allison J. Bruce
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01768143: Assessment of NAPS Performance.
Official title: A Reliable and Valid Assessment of Nurse Administered Propofol Sedation (NAPS) Performance.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Competence in Propofol Sedation for Endoscopy
Keywords: Propofol
Sedation
Endoscopy
nonanesthesiologist
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2013-01-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Endoscopy nurses of different competencylevel

Brief summary: To measure competencies in propofol sedation for endoscopic procedures (NAPS)through development, test and validation of a reliable assessment tool in a simulator setting.

Hypothesis: That the tool will demonstrate content and construct validity, ie. enable reliable measuring of necessary competencies of different levels in a reproducible way.


Eligibility criteria: Inclusion Criteria:

* eligible nurses, written informed consent.

Exclusion Criteria:

* Prior anesthesia or ICU experience

Primary outcomes:
measure: Assessed sedation performance score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen, Herlev
country: Denmark
facility: Herlev Hospital, Gastroenheden
state: Herlev
Study officials:
References:
Clinical trial NCT00332943: MR Colonography With Fecal Tagging. Barium vs. BariumFerumoxsil
Official title: MR Colonography With Fecal Tagging. Barium vs. BariumFerumoxsil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Colorectal Cancer
Polyps
Keywords: colorectal polyps
colorectal cancer
Virtual colonoscopy
Fecal tagging
MR colonography
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Gentofte, Copenhagen
First posted: 2006-06-02
Enrollment: 20
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 purpose of this study is to determine whether Barium or BariumFerumoxsil is better for fecal tagging in MR colonography. Patients referred to colonoscopy are offered MR colonography before colonoscopy. Two days before colonography, patients ingest either a contrast agent A (200 ml Barium sulphate solution 1g/ml)) four times a day or a 200 ml contrast agent B (Barium sulfate(25%) and Ferumoxil(75%)) four times a day, which will render fecal masses "invisible" on the following MR colonography. The patients are randomised to either contrast agent A or B. The examinations are evaluated by two independent blinded readers, who will rate the tagging quality of the contrast agents. The quality of tagging will be rated by a Visual Analog Scale (VAS) and Relative contrast (ReCon = Iwall - Ilumen/ Iwall + Ilumen).


Eligibility criteria: Inclusion Criteria:

* Suspicion of colorectal polyps or cancer
* Referred for colonoscopy

Exclusion Criteria:

* Suspicion of IBD
* Pacemaker
* Metal in the body
* Claustrophobia
* Pregnancy

Primary outcomes:
measure: Quality of fecal tagging agent
measure: Sensitivity of VAS score vs. ReCon score
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Radiology Copenhagen University Hospital Herlev
Study officials:
affiliation: Department of Radiology Copenhagen University Hospital Herlev
name: Michael P Achiam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02762643: DP-R213 Pharmacokinetics Study
Official title: An Open-label, Randomized, Crossover Study to Evaluate the Pharmacokinetics and Safety of a Fixed Dose Combination of Raloxifen/Cholecalciferol Compared With Coadministration of Raloxifen and Cholecalciferol in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: DP-R213
Lead sponsor: Alvogen Korea
Sponsor class: INDUSTRY
First posted: 2016-05-05
Enrollment: 61
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, crossover, Phase I clinical trial to compare the pharmacokinetics of DP-R213 (Raloxifenel and Cholecaliferol fixed dose combinations) in comparison to each component administered alone in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* IBW ±20%
* signed the informed consent form prior to the study participation

Exclusion Criteria:

* Clinically significant disease
* Previously donate whole blood within 2 months or component blood within 1 month
* Clinically significant allergic disease
* Taken IP in other trial within 3 months
* An impossible one who participates in clinical trial by investigator's decision including laboratory test result

Primary outcomes:
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: up to 96 hours post dose
measure: Peak Plasma Concentration (Cmax)
timeFrame: up to 96 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02904343: Evaluation of Domestic Hemodialysis Machine: A Multi-center Clinical Study
Official title: Evaluation of Domestic Hemodialysis Machine (WEGO DBB-27C) : A Multi-center Clinical Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hemodialysis
Keywords: hemodialysis machine
quality
safety
domestic
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An important reason for the costs of hemodialysis treatment in China are expensive is the hemodialysis machine and related products mainly rely on imports. Hemodialysis machine is the basis equipment of the hemodialysis treatment. After years of research and development, China has had the domestic hemodialysis machine. However, due to the lack of control studies of domestic and imported hemodialysis machine, thus causing the domestic hemodialysis machine promotion has been hindered. The aim of this study is to verify the quality and safety of domestic hemodialysis machine.


Eligibility criteria: Inclusion Criteria:

1. Age≥18, male or female
2. Maintenance hemodialysis duration\>3 months
3. Regular hemodialysis,3 times a week,4 hours per session
4. Sign the written informed consent

Exclusion Criteria:

1. Acute kidney injury
2. Prepare to transfer to kidney transplantation or peritoneal dialysis in a year.
3. Positive in Hepatitis B virus, hepatitis C virus, syphilis or HIV
4. Pregnancy or lactation
5. Under other drug trial
6. Acute infection, severe heart, lung, liver, nervous diseases, malignant tumor
7. Can not be treated in accordance with the research program

Primary outcomes:
measure: Adverse reactions associated with the use of dialysis machines
timeFrame: 0 to 3 months
Secondary outcomes:
measure: The results of endotoxin level of dialysate
timeFrame: 0,1,2,3 months
measure: The results of bacterial culture of dialysate
timeFrame: 0,1,2,3 months
measure: Clearance rate of uremic toxins
timeFrame: 0,1,2,3 months
Other outcomes:
Locations:
Study officials:
References: