louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03287453: Educational Intervention - Improving Knowledge and Screening Rates for Colorectal Cancer
Official title: Screen to Save Initiative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 108
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This clinical trial studies how well educational intervention works in improving knowledge and screening rates of colorectal cancer. An educational intervention, such as viewing an inflatable colon, PowerPoint presentation, or flip books/flipcharts, may help improve knowledge about colorectal cancer and how often people get checked for colorectal cancers.

Detailed description: PRIMARY OBJECTIVES:

I. To increase colorectal cancer (CRC) knowledge, attitudes, positive behavior change, intent for screening, and screening among at-risk groups.

OUTLINE:

Participants attend educational sessions comprising of an inflatable colon interactive exhibit that allows visitors to walk through a colon while seeing images, or a PowerPoint presentation that contains messages that are tailored to meet the cultural and linguistic needs of Black/African Americans, Appalachians, and Hispanics/Latinos, and flip books/flip charts. Participants also receive a copy of the study information sheet which contains the basic elements of informed consent and a pre-education session knowledge survey.

Eligibility criteria: Inclusion Criteria:

* Participants from Franklin County or from Appalachia Ohio (depending on program location)

Primary outcomes:
measure: Change in knowledge and degree to which reported intentions regarding colorectal cancer screening are related to the educational session
timeFrame: Up to two years
measure: Change in knowledge and strength of intention to be screened
timeFrame: Up to two years
measure: Frequency of reported family history of colorectal cancer
timeFrame: Up to two years
measure: Participants' plans for future screening
timeFrame: Up to two years
measure: Reasons reported for not obtaining colorectal screening
timeFrame: Up to two years
measure: Self-reported intentions to engage in behavior change to reduce risk of colorectal cancer
timeFrame: Up to two years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Electra Paskett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00857753: Relative Bioavailability of a Fentanyl Patch
Official title: A Study to Evaluate the Relative Bioavailability of a Fentanyl PAtch Transdermal Delivery System (25 ug/hr) (Sandoz) Compared to Duragesic (Fentanyl Transdermal SYstem 25 ug/hr Patches (Alza)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-03-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Tohe purpose of this study is to demonstrate the bioequivalence of a fentanyl patch transdermal delivery system.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on physical exam, medical history or clinical laboratory tests on screening.

Exclusion Criteria:

* Negative test for HIV and hepatitis B and C
* No history of drug or alcohol treatment
* No allergies to opiates

Primary outcomes:
measure: Bioequivalence according to US FDA guidelines
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novum Pharmaceutical Research Services
name: Darin B. Brimhall, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02545153: Fibrin Sealant for Cholangiotomy Closure Study
Official title: Randomised Controlled Trial of Fibrin Sealant to Prevent Bile Leakage After Cholangiotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Common Bile Duct Gall Stones
Infection
Bile Leak
Lead sponsor: Lasarettet i Enköping
Sponsor class: OTHER
First posted: 2015-09-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bile leak reduction from the common bile duct, as a result of glue appliance after cholangiotomy.

Detailed description: Laparoscopic common bile duct exploration is a way of dealing with common bile duct stones that has gained increasing acceptance. Following a cholangiotomy there is, however, the risk of bile leakage from the incision.

A way of avoiding leakage following cholangiotomy may be to apply fibrin sealant on the cholangiotomy.

The present study is based on patients undergoing laparoscopic cholecystectomy at the department of surgery, Enköping hospital, Sweden. The patients are informed about the study prior to the procedure. Cholangiography is performed routinely. In case common bile duct stones are encountered on the cholangiography, an incision is made in the common bile duct and the stones are extracted. After the stone extraction, a t tube is introduced into the cholangiotomy and the incision is closed with running Vicryl sutures.

When the cholangiotomy has been closed, the randomisation is performed with a sealed envelope system. If the patient is randomised to fibrin sealant, this is applied on the cholangiotomy. A passive drain is introduced before the abdomen is closed.

Postoperatively, the amount of bile in the passive drain is measured by an observer randomised to the allocation.

If the amount of bile in the drain does not exceed 100 ml three days postoperatively, a secondary cholangiography is performed through the t tube. If the contrast passes to the duodenum and no contrast leakage is seen, the t tube is withdrawn.

All postoperative complications are registered according to the Clavien-Dindo system.

Eligibility criteria: Inclusion Criteria:

* Gallbladder disease

Exclusion Criteria:

* Cancer/Tumor

Primary outcomes:
measure: Postoperative biliary leakage
timeFrame: From the the day of surgery until discharge and/or removal of abdominal drain, up to two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Enkoping
country: Sweden
facility: Lasarettet i Enkoping
state: Uppsala
Study officials:
affiliation: Karolinska Institutet
name: Gabriel Sandblom, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Darkahi B, Norden T, Sandblom G. Fibrin Sealant for Prevention of Bile Leakage After Laparoscopic Common Bile Duct Incision: Outcome of a Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2022 Feb;32(2):171-175. doi: 10.1089/lap.2020.0404. Epub 2021 Jun 14.
Clinical trial NCT04267653: Lactoferrin Efficacy Versus Ferrous Sulfate in Treatment of Patients With Iron Deficiency Anemia
Official title: Lactoferrin Efficacy Versus Ferrous Sulfate in Treatment of Patients With Iron Deficiency Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Iron Deficiency Anemia Treatment
Keywords: Iron deficiency anemia
Lactoferrin
Ferrous sulfate
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 96
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Lactoferrin (Lf) is a mammalian cationic iron binding glycoprotein belonging to the transferrin family which was discovered 70 years ago, and isolated simultaneously from human and bovine milks in 1960. It is widely distributed in all biological fluids and is also expressed by immune cells, which release it under stimulation by pathogens


Eligibility criteria: Inclusion Criteria:all patients with iron deficiency anemia from 2 to 15 years old

-

Exclusion Criteria:

* Anemia rather than iron deficiency anemia.
* Family history of blood disease.
* Patients with thalassemia trait.
* Patients with chronic illness.

Primary outcomes:
measure: comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia.
timeFrame: 30 days
measure: Comparison of efficacy of lactoferrin versus ferrous sulfate tharapy in treatment of patients with iron deficiency anemia.
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: AssuitU
Study officials:
affiliation: Assiut University
name: Ahmed Gaber Ahmed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01735253: Prospective Observatonal Study for Effect of Duodenojejunal Bypass and Gastric Bypass on T2DM Patients
Official title: Metabolic Surgery for Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Insulin Dependent Diabetes Mellitus
Keywords: metabolic surgery
gastric bypass
duodenojejunal bypass
type 2 DM
Lead sponsor: Inha University Hospital
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Surgical treatment for type 2 diabetes has been taken note especially in less obese or non obese patients. In Asian, the nuber of less obses or non obese patients with T2DM is greater than that of the obese.

We are trying to do a prospective observational study for the evaluation of the effect of duidenojejunal bypass and gastric bypass on the glycemoc control in those patients.

The selection criteria are type 2 diabetess, 20-60 years old, BMI 23-34 or 21-22 with viceral obesity, insulin use less than 10 years and the patients understanding the hypothesis of this study, risks, expecting effects and agreeing this study.

We are checking oral GTT, insulin level, C-peptide level, HbA1C, etc. with some anthropometric measurs preoperatively, postoperatively, at 3 month and 12 month.

We will compare the clinical factors at each time.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* HbA1C \> 7.0%
* BMI 23 - 34 or BMI 21-22 with viceral obesity
* insulin use less than 10 years
* uncerstanding the risks, hypothesis, expecting effects

Exclusion Criteria:

* type 1 diabetes
* C-peptide \< 1.0ng/ml
* BMI \< 21
* severe cardiovascular diseases or their history
* malignancy or history
* alcoholics, pituitary failrue
* history of severe ketosis, diabetic coma or precoma
* abnormal liver enzyme, over 3 fold of normal level
* liver cirrhosis or hepatitis
* serum creatinine \> 2.0mg/dL
* glucocorticoids user
* diabetes due to other endocrine diseases
* pancreatic disease
* anti-GAD Ab (+)
* the incongruity for surgery

Primary outcomes:
measure: Hemoglobin A1C
timeFrame: preoperatively, at 3month, at 12 month
Secondary outcomes:
measure: oral glucose tolerance test
timeFrame: preopertively, postoperatively, at 3 month, at 12 month
Other outcomes:
measure: insulin level
timeFrame: preoperatively, postoperatively, at 3 month, at 12 month
Locations:
city: Incheon
country: Korea, Republic of
facility: Yoonseok Heo
Study officials:
References:
Clinical trial NCT01587053: Anti Vitamin K Therapeutic Education
Official title: Anti Vitamin K Therapeutic Education With INR Self Measure Device Within Children From 0 to 18 Years
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardio-vascular Diseases
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2012-04-27
Enrollment: 57
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children from 0 to 18 years having AVK prescription

Brief summary: The purpose of this study is to measure the INR (International Normalized Ratio) time percentage in the target zone (TTR: time in therapeutic range) of children benefiting from the AVK therapeutic education program.


Eligibility criteria: Inclusion Criteria:

* age from 0 to 18 years
* AVK prescription
* to accept participating to AVK therapeutic education program
* informed consent form of parents or legal person

Exclusion Criteria:

* parents or legal person refusal to enter in the AVK therapeutic education

Primary outcomes:
measure: INR (International Normalized Ratio) time percentage in the target zone (TTR: time in therapeutic range)
timeFrame: up to 1 year
Secondary outcomes:
measure: Quality of life questionnaire
timeFrame: 2 years
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
Study officials:
affiliation: Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
name: Pascal AMEDRO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abassi H, Bajolle F, Werner O, Auer A, Marquina A, Mura T, Lavastre K, Guillaumont S, Manna F, Auquier P, Bonnet D, Amedro P. Health-related quality of life correlates with time in therapeutic range in children on anticoagulants with International Normalised Ratio self-monitoring. Arch Cardiovasc Dis. 2020 Dec;113(12):811-820. doi: 10.1016/j.acvd.2020.05.022. Epub 2020 Oct 14.
Clinical trial NCT04851353: Multiple Sensory Interventions On Infants' Pain and Physiological Distress During Neonatal Screening Procedures
Official title: Breast Milk as Multiple Sensory Interventions On Infants' Pain and Physiological Distress During Neonatal Screening Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Behavior
Pain, Acute
Physiological Stress
Breast Milk
Lead sponsor: National Defense Medical Center, Taiwan
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 250
Sex: ALL
Minimum age (years): 2
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study purposes are to compare the effects of different combinations of sensory interventions on newborns' pain responses, physiological distress (heart rate and oxygen saturation), and crying event during heel stick procedures.

Detailed description: Newborns undergo many necessary invasive procedures for routine care, but these treatments may cause stress and pain. The study purposes are to compare the effects of different combinations of sensory interventions on newborns' pain responses, physiological distress (heart rate and oxygen saturation), and crying event during heel stick procedures. This study was a prospective, randomized controlled trial. Infants were recruited by convenience sampling in a baby room of a medical center in northern Taiwan from September in 2017 to September in 2018. Newborns who met the criteria were recruited by blocked random to three treatment groups: (1)Gentle touch + Verbal comfort, (2) Smell + gentle touch + Verbal comfort, (3) Smell + Taste + Touch + Verbal comfort. Pain response was measured by the Neonatal Infant Pain Scale (NIPS). The physical distress events were measured by the abnormal heart rate and oxygen saturation event, and crying event. All data were collected 5 minutes before heel-stick (baseline), during heel-stick and in recovery status.

Eligibility criteria: Inclusion Criteria:

* Gestational age \> 36 weeks, birth weight \> 2200 g, and at least one parent agreed to participate.

Exclusion Criteria:

* had congenital anomalies and neurologic impairment

Primary outcomes:
measure: Infants' pain reponse
timeFrame: Six months
Secondary outcomes:
measure: The distress events of physiological parameters
timeFrame: Six months
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: National defense medical center
Study officials:
References:
Clinical trial NCT00155753: Genomewide Screening of Pathological Myopia
Official title: Genomewide Screening of Pathological Myopia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pathological Myopia
Keywords: pathological myopia, genomic
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Taiwanese

Brief summary: The purpose of this study is to evaluate the possible candidate gene of pathological myopia

Detailed description: High myopia (pathological myopia) is caused by excessive axial elongation that primarily involves the ora-equatorial area and the posterior pole. Peripheral fundus changes and posterior staphyloma formation are ophthalmoscopic evidences of this process. Pathological myopia often accompanied by glaucoma, cataracts, macular degeneration, and retinal detachment, leading to blindness when the damage to the retina is extremely severe. Population and family studies in Chinese have provided evidence for a genetic component to pathologic myopia. Children of myopic parents are more likely to have myopia than are children of nonmyopic parents. The ocular components (axial length, anterior chamber depth, and corneal curvature) and refractive errors of MZ twins are more closely aligned than are those of DZ twins.

Therefore, it is possible to search a potential candidate gene for myopia through the genomic study of pathological myopia.

Eligibility criteria: Inclusion Criteria:

* They are unrelated Chinese subjects with high myopia ≦-6.00D. The diagnosis of myopia is determined by the refractive error. Anisometropic individuals, with a refractive error of ≦-6.00 D for one eye and ≦-6.00 D for the other eye, with at least a 2-D difference between the two eyes, are considered unaffected.

Exclusion Criteria:

* Individuals are excluded if there is known ocular disease or insult that could predispose to myopia, such as retinopathy of prematurity or early-age media opacification, or if they had a known genetic disease associated with myopia, such as Stickler or Marfan syndrome.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospiyal
name: Yung-Feng Shih, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00001753: Study of the Effects of Temperature on Metabolism in Human Muscle
Official title: Study of Temperature Effects on Skeletal Muscle Aerobic Energy Metabolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Exercise
MRI
MRS
Normal Volunteer
Tibialix Anterior
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: This study will examine the role of temperature in changing energy metabolism in human muscle. In order to do this, researchers will use magnetic resonance imaging (MRI) to provide information about how parts of muscle operate during exercise.

Magnetic resonance imaging (MRI) is a diagnostic tool that creates high quality images of the human body without the use of X-ray (radiation). In this study, MRI will be used to measure the temperature and energy level of specific muscles during rest and exercise. In addition, the muscles being tested will be heated and cooled to see if temperature directly affects levels of energy in muscle.

Detailed description: This study will examine the role of temperature in modulating aspects of energy metabolism in human skeletal muscle. Tests will be conducted at rest and during concentric dorsiflexion exercise of the Tibialis anterior (TA) muscle using an existing custom-designed dynamometer in conjunction with mild local heating and cooling. Magnetic resonance spectroscopy (MRS), performed in a 4-tesla whole-body NMR system, will be used to non-invasively measure muscle temperature and energy-state. Specifically these tests will assess the extent to which temperature changes occur during aerobic exercise and how small temperature changes affect mitochondrial function in-vivo.

Eligibility criteria: Ages 18 to 50.

Male and female subjects.

Capable of giving informed consent.

Healthy normal volunteers.

No cardiac pacemaker of implantable defibrillator.

No aneurysm clip.

No neural stimulator (e.g. TENS-unit).

No ear implant of any type.

No metal in the eye (e.g. from machining).

No implanted device (e.g. insulin pump, drug infusion device).

No metallic foreign body, shrapnel, or bullet.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Heart, Lung and Blood Institute (NHLBI)
state: Maryland
Study officials:
References:
citation: Fowler MD, Ryschon TW, Wysong RE, Combs CA, Balaban RS. Normalized metabolic stress for 31P-MR spectroscopy studies of human skeletal muscle: MVC vs. muscle volume. J Appl Physiol (1985). 1997 Sep;83(3):875-83. doi: 10.1152/jappl.1997.83.3.875.