louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01014039: Telemark Polyp Study, a Trial on Colonoscopy Screening
Official title: Telemark Polyp Study, a Randomized Trial on Colonoscopy Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Norwegian Department of Health and Social Affairs
Sponsor class: OTHER_GOV
First posted: 2009-11-16
Enrollment: 1433
Sex: ALL
Minimum age (years): 55
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Colonoscopy screening to reduce mortality and incidence of colorectal cancer (CRC) has been implemented in many western countries. The estimated effect is based on case-control and observational studies. There are no randomized trials quantifying the effect of colonoscopy screening on CRC incidence and mortality.

The present study investigates the effect of a population-based once-only colonoscopy screening with polypectomy on the incidence of CRC in an average risk population.

In 1983, 900 individuals 55 to 64 years of age were randomly drawn from the population registry of Telemark county, Norway. 400 of these were invited to a flexible sigmoidoscopy screening examination, and 400 individuals were not offered any screening. In 1996, the remainder, both cohorts from 1983 were invited to a colonoscopy screening examination. A new age and sex matched control group, not being offered screening, was randomly drawn from the same registry. Both groups are to be followed with regard to CRC incidence, CRC mortality and all-cause mortality through national Norwegian registries.

Detailed description: This as a randomized study of once-only colonoscopy screening (n=685) vs/no screening(care as usual)(n=684). Men and women at 63-72 years of age are recruited from the population registry. The intervention group is invited for screening after a bowel cleansing regimen at home. Follow-up is restricted to trace events (colorectal cancer incidence and deaths) through national registries.

Eligibility criteria: Inclusion Criteria:

* Age 55 to 64 years old
* Both male and female

Exclusion criteria:

- Colorectal cancer diagnosed before study entry

Primary outcomes:
measure: Colorectal cancer mortality
timeFrame: at least 15 years of follow-up
Secondary outcomes:
measure: All cause mortality
timeFrame: at least 15 years of follow-up
measure: colorectal cancer incidence
timeFrame: at least 15 years of follow-up
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Cancer Registry of Norway
Study officials:
affiliation: Sykehuset Telemark
name: Geir Hoff, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02582086: Study of a New Topical Natural Health Product for the Treatment of Herpes Labialis
Official title: A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Topical Natural Health Product for the Treatment of Herpes Labialis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Herpes Labialis
Lead sponsor: Laboratoire Boreaderme Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the safety and efficacy of a topical natural health product in comparison to placebo for the treatment of herpes labialis.


Eligibility criteria: Inclusion Criteria:

* Female and male, in good health, 18 years of age or older,
* With history of recurrent herpes labialis with at least twice a year during the past twenty-four months,
* Agreeing not to take another treatment against cold sore, nor anti-inflammatory, antibiotics and steroids,
* Cooperating in the study, able to be monitored at each visit, aware of the demands and duration of the controls, thus allowing perfect adherence to the established protocol,
* Must be willing and able to participate and to provide written informed consent,
* Female subjects of childbearing potential must have a negative pregnancy test at screening and agree to use a proper contraceptive method during the study.

Exclusion Criteria:

* Volunteers who refuse to introduce the product to be tested in its routine,
* With a history of hypersensitivity to the type of product to be tested (e.g., products that contain essential oil),
* Who have a history of eczema, topical dermatitis, psoriasis or significant skin anomalies on the areas to be tested,
* Who suffer from a serious illness or health problem or a critical or progressive disease,
* Who have taken prescription or over the counter medication that could affect skin characteristics or could bias the study (i.e. antibiotics, antihistamines, anti-inflammatories...) within 7 days prior to study beginning,
* Who have recently acquired or who currently have significant skin pigmentation, who frequent tanning salons or foresee exposure to the sun during the study,
* Who abuse alcohol, drugs and/or tobacco,
* Female subjects who are pregnant, breastfeeding or expecting to become pregnant during the study.

Primary outcomes:
measure: Time to healing as assessed by the investigator
timeFrame: up to 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Evalulab Inc
state: Quebec
Study officials:
References:
Clinical trial NCT06393686: The Effect of Yoga on the Fitness of Children
Official title: Impact of Yoga Intervention on Physical Fitness Parameters in Preadolescent Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Test
Physical Endurance
Muscles
Keywords: Yoga
Muscle Stretching Exercises
Physical Endurance
Lead sponsor: Near East University, Turkey
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 52
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RANDOMIZED CONTROLLED TRIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the effect of yoga on physical fitness among healthy primary school children using a randomized control design. A total of 52 children, ages 8-13, will be randomly assigned to either the Yoga Group or the Control Group. Participants will be assessed using the EUROFIT Test Battery as the primary outcome measure.

The Yoga Group will do 45-minute yoga sessions twice a week for 10 weeks, while the Control Group will not receive any intervention. Outcome assessments will be repeated at the end of the 10-week intervention period.

Detailed description: This investigation is a randomized controlled trial designed to assess the physical fitness levels among primary school-age children subjected to diverse yoga interventions, comparing them with the outcomes observed in a control group devoid of such interventions.The study encompasses a 10-week intervention phase, during which participants undergo evaluation at two specific time points: Initial assessment (M1), conducted one week preceding the commencement of the exercise program, and subsequent evaluation (M2), executed one week post the conclusion of the program.Anthropometric measurements will determine the height of the participants using a non-elastic measuring tape (SECA brand) attached to the wall. Body Mass Index (BMI) will be calculated with the Tanita MC-180MA III device.The physical fitness of children will be measured with the Eurofit test battery.

Eligibility criteria: Inclusion Criteria:

* Participants who do not have any mental or physical disabilities
* Participants who have not participated in any exercise regime for the previous six months

Exclusion Criteria:

• Individuals who do not participate in 90 percent of the 10-week yoga training program.

Primary outcomes:
measure: EUROFIT Test Battery
timeFrame: 12 weeks
measure: Anthropometric measurements
timeFrame: 12 weeks
measure: Body Mass Index
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Near East University
Study officials:
References:
Clinical trial NCT03242486: Clinical Evaluation of Toric Intraocular Lens
Official title: Safety and Effectiveness Evaluation of Toric Intraocular Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Astigmatism
Lead sponsor: Nidek Co. LTD.
Sponsor class: INDUSTRY
First posted: 2017-08-08
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate efficacy and safety of the toric IOL implanted into aphakic eye with corneal astigmatism after cataract surgery.

Detailed description: Effectiveness

* primary endpoint is visual acuity with pre-determined spherical correction.
* secondary endpoint is UCVA with spherical correction, BSCVA, Refractive Cylinder Correction, Spherical Equivalent, IOL rotation

Safety

* number and percentage of adverse event

Eligibility criteria: Inclusion Criteria:

* Patients with age of 40 years or older
* Patients with age-related cataract in one eye or both eyes.
* Patients willing to participate in the required postoperative study.
* Patient who can understand and sign the consent document.
* An eye whose pupil diameter after mydriasis is 5 mm or greater.
* An eye whose preoperative corneal cylindrical power is 1.0D or more.
* An eye whose postoperative astigmatism is predicted to be less than 0.5 D.
* An eye whose postoperative visual acuity with spherical addition is 0.8 D or more.

Exclusion Criteria:

* Disorder of corneal endothelium
* Uncontrolled glaucoma
* Active Uveitis
* Diabetic retinopathy
* Retinal detachment
* Congenital ocular anomalies
* Choroidal hemorrhage
* Shallow anterior chamber
* Microphthalmus
* Corneal dystrophy
* Optic atrophy
* Ocular hypertension
* Amblyopia
* Previous history of corneal transplantation
* Active Iritis
* Corneal disorder
* Macular degeneration
* Retinal degeneration
* Clinically significant change in macula and/or retinal pigment epithelium
* Corneal irregular astigmatism
* Atopic disease
* Brittleness of Zinn's zonule, fractured zonule and lens luxation (including subluxation)
* Pseudo-exfoliation syndrome
* Iris neovascularization
* Long axis length eye (axis length : 28mm or more)
* Severe dry eye, abnormality of the lens surface
* Concurrent participation in another drug and device clinical investigation
* Patient with mental deficiency or psychiatric disorder and/or who is not capable of expressing the consent of participating in the trial
* Patient who is judged inappropriate by investigators or sub-investigators

Primary outcomes:
measure: Visual acuity
timeFrame: postoperative 6 months
Secondary outcomes:
measure: Visual acuity
timeFrame: postoperative 6 months
measure: IOL rotation
timeFrame: postoperative 6 months
Other outcomes:
measure: Adverse events
timeFrame: one year
Locations:
Study officials:
References:
citation: Sugita I, Ogawa T, Ichikawa K, Okita T, Negishi K, Nakano T, Tsuneoka H. Rotational stability and clinical outcomes of a new one piece toric intraocular lens with anchor-wing haptics. BMC Ophthalmol. 2022 Jan 15;22(1):26. doi: 10.1186/s12886-021-02240-7.
Clinical trial NCT04936386: Knowledge and Perspective of Healthcare Professionals About Female Genital Mutation
Official title: Knowledge and Perspective of Healthcare Professionals Related to Female Genital Mutation: a Regional Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Genital Mutilation Type I Status
Female Genital Mutilation Type II Status
Female Genital Mutilation Type III Status
Keywords: female genital mutilation
healthcare professionals
Lead sponsor: Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthcare professionals working in Genoa

Brief summary: Each year over three million girls are at risk of being subjected to female genital mutilation (FGM) in several African countries. This regional survey aims to evaluate knowledge and perspective of healthcare professionals related to FGM.

Detailed description: The survey iscomposed of 4 different sections: the first section included questions about demographic data of participants; the second part evaluated responders' knowledge about FGM; the third section focused on participants' working experience with patients affected by FGM and personal attitude related to this topic.

Eligibility criteria: Inclusion Criteria:

* medical specialists
* general medical practicians
* medical residents
* midwives
* professional nurses
* medical students
* residence in Liguria (Italy)

Primary outcomes:
measure: Mean score related to knowledge about FGM
timeFrame: Baseline
measure: Proportion of responders with active role in contrasting the procedures
timeFrame: Baseline
measure: Proportion of responders feeling confortable in treating patients affected
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
Study officials:
References:
citation: Abdulcadir J, Catania L, Hindin MJ, Say L, Petignat P, Abdulcadir O. Female Genital Mutilation: A Visual Reference and Learning Tool for Health Care Professionals. Obstet Gynecol. 2016 Nov;128(5):958-963. doi: 10.1097/AOG.0000000000001686.
Clinical trial NCT02399839: Global Lomitapide Pregnancy Exposure Registry
Official title: Global Lomitapide Pregnancy Exposure Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pregnancy
Lead sponsor: Amryt Pharma
Sponsor class: INDUSTRY
First posted: 2015-03-26
Enrollment: 5
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant Females

Brief summary: To evaluate the outcomes of pregnancy in women treated with lomitapide.

Detailed description: To evaluate the outcomes of pregnancy in women treated with lomitapide at any time within 30 days prior to first day of Last Menstrual Period (LMP) or during pregnancy. The outcomes of primary interest are major congenital anomalies.

Eligibility criteria: Inclusion Criteria:

* Pregnant females exposed to lomitapide at any time within 30 days prior to first day of the LMP or during pregnancy.

Exclusion Criteria:

* Patients who are unable or unwilling to provide written informed consent or assent are not eligible to participate in the PER.

Primary outcomes:
measure: Pregnancy
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinikum der Universität München
state: Bavaria
Study officials:
affiliation: Amryt Pharmaceuticals
name: Sallyann O'Brien
role: STUDY_DIRECTOR
References:
Clinical trial NCT03464539: Occult Obscure Gastrointestinal Bleeding
Official title: Occult Obscure Gastrointestinal Bleeding (OGIB) in Colonic Diverticulitis Using Polyglucosamine: a Registry Study Following a Standard Management Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Bleeding
Lead sponsor: Blymum Srl
Sponsor class: OTHER
First posted: 2018-03-14
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To test the activity of a polyglucosamine (PG) together with a Standard Management protocol (SM) on the occult and obscure gastrointestinal bleeding (OGIB) and the clinical symptoms in patients suffering from colonic diverticulitis (CD).

Detailed description: The trial was conducted in a single center and subjects were participating to the San Valentino Vascular Screening Project (SVVSP). Sixty patients with history of colonic diverticulitis (CD) and occult obscure gastrointestinal bleeding (OGIB) were recruited. All subjects were following a Standard Management (SM) protocol consisting of diet and lifestyle modifications, and were freely choosing to be treated with polyglucosamine (PG) or to follow the SM only. Two groups of 30 cases each were formed and followed for 3 months.

Diet was controlled three times (baseline and during the first and third month), through the Food Intake Assessment (FIA) which consisted of the weekly analysis of 25 different servings (e,g fruits, vegetables, pulses, first dish, meat, processed meat, cheese). The lifestyle modification consisted of physical exercise (9 MET (Metabolic Equivalents) -h/week of brisk walking) and oral hygiene.

The main variable was OGIB, that was measured using Hemoccult Sensa Fecal Occult Blood Procedure.

Ancillary variables where the hs-CRP (high sensitivity C Ractive Protein) and the daily gastrointestinal discomfort (GID) measured thorough a visual analogue scale (VAS) from 0 to 10.

All variables were taken at baseline, after one and three months with the exception of GID that was measured also after one week of treatment.

Eligibility criteria: Inclusion Criteria:

* Subjects aged between 55 to 65 years (males and females).
* CD diagnosis.
* DICA (Diverticular Inflammation and Complication Assessment) class DICA 2 or DICA 3.
* OGIB positive to Hemoccult Sensa Fecal Occult Blood Procedure.

Exclusion Criteria:

* Subjects with Class DICA \> 3.
* Therapy with mesalazine antibiotics and probiotics.
* Cancer of any type (a part from benign polyposis),
* Alcoholism.
* Parkinsonism.
* Alzheimer's Disease.
* Severe depression.
* Drug addiction.

Primary outcomes:
measure: Change of Occult bleeding
timeFrame: Baseline - 1 month - 3 months
Secondary outcomes:
measure: Gastrointestinal discomfort
timeFrame: Baseline - 1 week - 1 month - 3 months
Other outcomes:
Locations:
city: Pescara
country: Italy
facility: Spoltore - Pescara
Study officials:
affiliation: University of Chieti
name: Gianni Belcaro, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02072239: Angioshield First-In-Human Study to Demonstrate the Preliminary Safety and Efficacy
Official title: First-In-Human Study to Demonstrate the Preliminary Safety and Efficacy of the Angioshield System to Provide Mechanical Support for Vein Grafts Used in CABG Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: CABG
Intimal Hyperplasia
Atherosclerosis
Myocardial Infarction
Lead sponsor: Neograft Technologies, Incorporated
Sponsor class: INDUSTRY
First posted: 2014-02-26
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether or not the Angioshield device can be safely applied to support saphenous vein grafts used in standard coronary bypass surgery.

Detailed description: \\This is a first in human study which is intended to determine if a larger pivotal study is justified.

Eligibility criteria: Inclusion Criteria:

Subject will be eligible for inclusion in the investigation if he/she:

* is between the ages of 18 and 80 years of age, inclusive
* requires Coronary Atery Bypass Graft (CABG) surgery with minimum of one SVG used to bypass a stenosis in the Right Coronary, the Circumflex, a Diagonal, or an Obtuse Marginal artery, due to atherosclerotic coronary artery disease
* is able to give their informed written consent
* is willing and able to complete all follow-up visits and procedures

Exclusion Criteria:

Subject will be excluded from participation in the investigation if he/she:

* is currently enrolled in another clinical investigation
* is unable to tolerate or comply with required post-surgical medications or imaging (e.g., anticoagulation regimen; or known allergy to contrast agent)
* is or may be pregnant or is lactating, or plans to become pregnant in the next 12 months
* shows a presence of hypercoagulable state or history of idiopathic venous or arterial thrombosis
* has had an acute MI within the last 21 days
* has had a previous CABG
* requires emergency surgery
* has a left ejection fraction (LEF) less than 20%
* has a target vessel stenosis of less than 70%
* has a transmural infarct of the target artery territory
* currently requiring dialysis
* is having concomitant-surgery of any kind
* has varicose veins
* has had previous saphenectomy

Primary outcomes:
measure: MACE
timeFrame: 30 days
Secondary outcomes:
measure: MACE and Graft Patency
timeFrame: 30, 90 and 365 Days
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Pope John Paul II Hospital
Study officials:
affiliation: Pope John Paul II Hospital and Cardiology Collegium Medicum Jagiellonian University, Krakow, Poland
name: Jerzy Sadowski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00718939: Rheos® Diastolic Heart Failure Trial
Official title: Rheos® Diastolic Heart Failure Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diastolic Heart Failure
Keywords: Diastolic Heart Failure
Cardiac dysfunction
Heart Failure
Lead sponsor: CVRx, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-21
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The CVRx® Rheos® Diastolic Heart Failure Trial is a prospective, randomized, double blind trial with up to 60 subjects conducted at up to five centers in Europe. All subjects will be followed up to one year post implant.


Eligibility criteria: Inclusion Criteria:

* Be at least 21 years of age.
* Have bilateral carotid bifurcations that are below the level of the mandible.
* Have a left ventricular ejection fraction ≥ 45%.
* Clinical Heart Failure with elevated BNP or NT-Pro-BNP.

Exclusion Criteria:

* History of or suspected baroreflex failure or autonomic neuropathy.
* History of symptomatic bradyarrhythmias, pericardial constriction, infiltrative cardiomyopathy, cardiac valvular disease.
* Organ or hematologic transplant.
* History of prior surgery, radiation, or stent placement in carotid sinus region.
* History of severe chronic kidney disease.
* Life expectancy to less than one year.

Primary outcomes:
measure: Assess left ventricular mass index (LVMI).
timeFrame: at six months post- randomization.
measure: Assess safety by evaluating all adverse events.
timeFrame: through six months post -implant
Secondary outcomes:
measure: To assess difference between randomization groups in blood pressure changes, blood levels and quality of life.
timeFrame: six months post-implant
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik Forschungsgesellschaft mbH
city: Hamburg-Reinbek
country: Germany
facility: Krankenhaus Reinbek St.Adolfsstif
city: Hannover
country: Germany
facility: Medizinische Hoschschule Hannover
city: Koeln
country: Germany
facility: University of Cologne
Study officials:
affiliation: Medizinische Hoschschule Hannover
name: Maximilian A Pichlmaier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kerckhoff-Klinik Forschungsgesellschaft mbH
name: Johannes Sperzel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cologne
name: Prof. Uta Hoppe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Krankenhaus Reinbek St.Adolfsstif
name: Herbert Naegele, MD
role: PRINCIPAL_INVESTIGATOR
References: