louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05182996: Perceptions and Barriers About Cessation of Smoking Among IBD Patients
Official title: Perceptions and Barriers About Cessation of Smoking Among IBD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Smoking
Inflammatory Bowel Diseases
Lead sponsor: Keimyung University Dongsan Medical Center
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will investigate the perception of the relationship between smoking and inflammatory bowel disease by surveying inflammatory bowel disease patients. Afterward, the relationship between smoking and inflammatory bowel disease will be explained, and the smoking cessation rate will be investigated three months later.

Detailed description: A survey is conducted on patients with inflammatory bowel disease (IBD). Current smoking status, daily smoking amount, smoking period, perception of smoking effect on the induction of Crohn's disease (CD) or ulcerative colitis (UC), and perception of the effect of smoking on the course of CD or UC were investigated. Moreover, the intention to quit smoking is investigated. After the survey, information on the effects of smoking on CD or IBD is provided, and smoking cessation education is provided. After three months, the patients' smoking behavior was investigated, and the smoking cessation rate was investigated.

Eligibility criteria: Inclusion Criteria:

* Patients previously diagnosed with inflammatory bowel disease or newly diagnosed with inflammatory bowel disease

Exclusion Criteria:

* Those who do not agree to the survey or smoking cessation education

Primary outcomes:
measure: smoking cessation rate
timeFrame: 3 month later
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: KeimyungUniversity
state: Jung-gu
Study officials:
References:
Clinical trial NCT02636296: The Effects of 12 Weeks Pilates-inspired Exercise Training on Functional Performance in Older Women
Official title: The Effects of 12 Weeks Pilates-inspired Exercise Training on Functional Performance in Older Women: a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Pilates method
elderly
postural balance
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Federal University of São Paulo
First posted: 2015-12-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the present study was to investigate the effects of 12-week Pilates-inspired exercise on functional performance in community-dwelling older women.

Detailed description: Pilates is an exercise system developed over 70 years ago that has been recently received attention due to its beneficial effects on postural stability, coordination, muscle strength and flexibility. The studies published involving Pilates were very different among them regarding intervention period (5, 8, 12 and 24 weeks), frequency (2 and 3 sessions/week) and exercises (mat, mat with accessories, apparatus and others combinations), making meaningful comparison difficult. Furthermore, other important physical features to maintain an independent life at older age, such as cardiorespiratory fitness, were accessed in few studies. So, the effective benefits of Pilates method on physical fitness of community-dwelling older people remain unclear.

Eligibility criteria: Inclusion Criteria:

* good health based on clinical examination (doctor's certificate)
* good functional capacity(physical examination)

Exclusion Criteria:

* current smokers
* obese (BMI \>30 Kg/cm2)
* musculoskeletal limitations
* neurologic diseases
* cardiovascular diseases
* condition that contraindicated exercise
* regularly engaged in other physical conditioning program (\>2x/week and/or \>150min/week)

Primary outcomes:
measure: physical fitness
timeFrame: changes from baseline physical fitness at 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05194696: Caffeine Consumption and Cataract Prevention
Official title: The Impact of Caffeine Consumption on Preventing Cataract
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cataract
Keywords: Cataract
Caffeine
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 12000
Sex: ALL
Minimum age (years): 21
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cataracts awaiting cataract surgery

Brief summary: Effect of peroral caffeine consumption on the delay of cataract onset.

Detailed description: Several experimental studies have shown that caffeine inhibits cataract development by scavenging reactive oxygen species. Evidence from epidemiological studies, however, is controversial. Varma et al., found that the incidence of cataract blindness in humans was significantly lower in groups consuming higher amounts of coffee in comparison to the groups with lower coffee intake. Moreover, Rautiainen et al. showed that the dietary total antioxidant capacity including coffee of middle-aged and elderly women was inversely associated with the risk of age-dependent cataract. Another population-based study involving the population residing in Beaver Dam, Wisconsin, did not find a meaningful association between 10-year cumulative incidence of cataract and the amount of caffeine intake.

Although cataracts can be surgically removed, barriers that prevent access to surgery are a problem in many countries. Moreover, no prophylactic treatments are currently available to prevent the onset of cataract. Yet estimates indicate that a delay of only 10 years in the onset of cataract could reduce the need for cataract surgery by as much as 50%.

The present study aims to investigate whether peroral caffeine consumption on a regular daily basis for a significant period of time and sufficient dose delays cataract development.

12000 eyes of 6000 patients will be included into this study. Patient will have to fill out a questionnaire for caffeine consumption habits during lifetime and risk factors for cataract development. Further, a complete ophthalmic examination, cataract grading, refraction, visual testing, and biometry will be performed.

Eligibility criteria: Inclusion Criteria:

* age older than 21 years
* cataract

Exclusion Criteria:

- age younger than 21 years

Primary outcomes:
measure: Caffeine consumption
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Study officials:
affiliation: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
name: Oliver Findl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00902096: Predictors of Cord Blood Immunoglobin E (IgE) Levels
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atopy
Keywords: cord blood
IgE
prenatal
predictor
Lead sponsor: Min-Sheng General Hospital
Sponsor class: OTHER
First posted: 2009-05-14
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital and primary care clinic based study

Brief summary: Background: Increased total serum IgE levels are a common characteristic of atopic diseases. Increased cord blood IgE levels, in conjunction with a family history of atopy, are associated with the development of allergic diseases in children. However, little is known about predictors of cord blood IgE levels.

Objective: The aim of our study was to identify predictors of cord blood IgE levels in an ongoing large birth cohort of infants with or without a family history of atopy.

Methods: Blood sampling of mothers was performed just before the delivery of newborns. Cord blood was also collected when the child was born. Maternal and cord blood was measured for IgE levels and cytokines. Questionnaires were administered after birth of the infant.


Eligibility criteria: Inclusion Criteria:

* Mothers in pregnancy 18 years of age or older, AND
* Mothers able to speak Chinese.

Exclusion Criteria:

* Infant delivered at less than 36 weeks' gestation,
* Infant with Apgar score in 5 minutes after birth \< 7,
* Infant with a major congenital anomaly, OR
* Infant admitted to an intensive care unit.

Primary outcomes:
measure: cord blood IgE
timeFrame: at birth
Secondary outcomes:
measure: Cord blood cytokines or other mediators
timeFrame: at birth
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Min-Sheng General Hospital
Study officials:
affiliation: Min-Sheng General Hospital
name: Chien-Han Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02033096: Observational Follow-up of Participants From Clinical Trial 64,185-202 (NCT00850993)
Official title: A 4-Year Follow-up, Blinded-Outcomes Trial of Subjects Having Received Stannsoporfin or Placebo in Clinical Trial 64,185-202
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Jaundice
Neonatal Hyperbilirubinemia
Keywords: stannsoporfin
hyperbilirubinemia
heme oxygenase
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2014-01-10
Enrollment: 42
Sex: ALL
Minimum age (years): 30
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Babies who participated in protocol 64,185-202 (NCT00850993)

Brief summary: Observational follow-up of participants from earlier interventional trial 64,185-202 (NCT00850993).

No interventions were administered during this follow-up study.


Eligibility criteria: Inclusion Criteria:

Participants who received treatment in clinical trial 64,185-202 and for whom informed consent was given for long term safety followup

Exclusion Criteria:

Participants were excluded by the investigator for medical reasons or by parents/guardians withdrawing consent

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: within 52 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mallinckrodt
name: Clinical Study Leader
role: STUDY_DIRECTOR
References:
Clinical trial NCT02556996: Efficacy of an Oral, Killed Enterotoxigenic Escherichia Coli Vaccine in Prevention of Diarrhea in Egyptian Infants and Young Children
Official title: Efficacy of an Oral, Killed Enterotoxigenic Escherichia Coli Vaccine in Prevention of Diarrhea in Egyptian Infants and Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diarrhea
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
Collaborators: name: U.S. Naval Medical Research Unit No. 3
name: Ministry of Health and Population, Egypt
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: International Vaccine Institute
name: Göteborg University
First posted: 2015-09-22
Enrollment: 356
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized, double-blind, placebo-controlled clinical trial performed in Egyptian children 6-18 months of age. The primary aim of the study is to determine the protective efficacy of an oral, inactivated whole-cell enterotoxigenic Escherichia coli (ETEC) vaccine against diarrhea associated with excretion of ETEC that express a vaccine-shared antigen over a one year period of follow-up by active surveillance. The vaccine consists of a mixture of five formalin-killed ETEC bacteria expressing prevalent ETEC colonization factors and recombinant cholera toxin B-subunit (killed ETEC/rCTB vaccine). The placebo preparation is heat-killed Escherichia coli K-12 bacteria.


Eligibility criteria: Inclusion Criteria:

1. Willingness of parent to have the child participate;
2. Plans to reside in catchment area continuously for at least one year

Exclusion Criteria:

1. Global developmental delay
2. Severe malnutrition
3. Chronic bedridden status
4. Serious chronic disorder requiring chronic medication

Primary outcomes:
measure: Time to first event of diarrhea due to vaccine-preventable ETEC (VP-ETEC) as defined below, and no other copathogen.
timeFrame: 365-day period starting 14 days after the third vaccination
Secondary outcomes:
measure: Time to first event of diarrhea due to ST-only ETEC expressing a vaccine-shared CF (ST-VCF-ETEC) as defined below, and no other copathogen..
timeFrame: 365-day period starting 14 days after the third vaccination
measure: All events of diarrhea irrespective of etiology
timeFrame: 365-day period starting 14 days after the third vaccination
measure: IgG seroconversion
timeFrame: Baseline serum specimen is collected before first dose and post-vaccination specimen collected 14 days after third dose
measure: IgA seroconversion
timeFrame: Baseline serum specimen is collected before first dose and post-vaccination specimen collected 14 days after third dose
measure: Number of solicited adverse events
timeFrame: 3-day period after each dose
Other outcomes:
Locations:
Study officials:
affiliation: Naval Medical Research Center
name: Stephen Savarino, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00543296: Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment
Official title: Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Uveitis
Keywords: uveitis
Cystoid Macular Edema (CME)
fluocinolone acetonide
non-infectious uveitis affecting the posterior segment
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Bausch & Lomb Incorporated
First posted: 2007-10-12
Enrollment: 21
Sex: ALL
Standard ages: CHILD
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 collect data on patients with severe uveitis that have required re-implantation of the sustained-release fluocinolone drug delivery device due to depletion of study drug in their previous implanted device.

Detailed description: Purpose: To collect medical information on a sustained release drug delivery system that delivers the corticosteroid, fluocinolone acetonide, directly into the vitreous cavity of the eye. This system has the potential to maintain therapeutic drug levels in the eye while reducing systemic exposure to the drug to negligible levels. RetisertTM is the trade name for the intravitreal fluocinolone acetonide implant.

Hypothesis: The RetisertTM will be a safe and effective method to manage patients with severe uveitis

Eligibility criteria: Inclusion Criteria:

* Non-infectious intermediate, posterior or panuveitis
* Previous placement of fluocinolone acetonide implant with initial uveitis quiescence and subsequent recurrence of inflammation once implant depleted of drug

Exclusion Criteria:

* Infectious uveitis

Primary outcomes:
measure: Number of Eyes With Inflammation Recurrence
timeFrame: 5 years
Secondary outcomes:
measure: Percentage of Eyes With Improvement in Visual Acuity
timeFrame: baseline to 52 weeks
measure: Number of Participant's Eye Requiring Adjunctive Therapy
timeFrame: 5 years
measure: Number of Eyes With Increased Intraocular Pressure
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Glenn J Jaffe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04753996: Characterization of Biliary Cell-derived Organoids from Bile of PSC and Non-PSC Patients
Official title: Characterization of Biliary Cell-derived Organoids from Bile of PSC and Non-PSC Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Sclerosing Cholangitis
PSC
Cholangiocarcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-02-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with Primary Sclerosing Cholangitis (PSC) and controls without PSC will be able to participate in this study.

Brief summary: The purpose of this research is to create a collection of bile, bile duct brushings and medical information from people with Primary Sclerosing Cholangitis (PSC) and controls to learn more about changes that occur in the liver.

Detailed description: The study will ask participants to provide bile and/or bile duct cytology brushings at time of endoscopic retrograde cholangiopancreatography (ERCP) or cholecystectomy (gallbladder removal). The bile and brushings will be used to generate and perpetuate bile-derived organoids using an established matrigel-based protocol. These organoids will then be used in downstream experiments to better understand disease-specific alterations to biological pathways informative of disease pathogenesis

Eligibility criteria: Inclusion Criteria:

PSC

* Patients diagnosed with PSC between the age of 18 and 85.
* The diagnosis of PSC will be based on standard PSC criteria including clinical and biochemical evidence of chronic cholestasis of at least six months duration, positive cholangiographic findings and compatible liver biopsies if available.
* Women with PSC of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation. Patients with PSC and Cholangiocarcinoma will be included.

Controls

• Controls without history of PSC or evidence of other chronic liver disease of either gender that will participate in this study should be between the ages of 18-85.

Exclusion Criteria:

* Patients unable to provide inform consent.
* Prisoners and institutionalized individuals.
* PSC with orthotopic liver transplantation
* History of Roux En Y procedure

Primary outcomes:
measure: Number of participants in study.
timeFrame: 20 years
Secondary outcomes:
measure: Number of samples (per type)
timeFrame: 20 years
measure: Number of clinical phenotypes and/or observations.
timeFrame: 20 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Konstantinos Lazaridis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04258696: Assessment of Lateral and Vertical Tissue Displacement Obtained by the Retraction Cord and Diode Laser
Official title: Assessment of Lateral and Vertical Tissue Displacement Obtained by the Retraction Cord and Diode Laser
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endodontically-Treated Teeth
Spacing of Anterior Maxillary Teeth
Broken Teeth Injury With Complication
Keywords: Gingival retraction
Gingival displacement
Diode laser
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-02-06
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In fixed prosthodontic treatment, deflection of gingival tissues for diagnosis or making an impression is one of the important phases. Gingival displacement is defined as "displacement of gingival tissues both in vertical and lateral dimensions". Lateral retraction displaces the tissues so that an adequate bulk of impression material can be interfaced with the prepared tooth. Vertical retraction exposes the uncut portion of the tooth apical to the finish line Conventional gingival retraction cord technique may injure the healthy epithelial lining and result in postoperative gingival recession The diode laser has been used for displacing gingiva to make a deﬁnitive impression. Rather than displacing gingival tissue, it removes the epithelial lining from the sulcus.

The aim of the Study is to compare between the Ultrapak retraction cord and diode laser regarding the amount of vertical and lateral retraction and patient comfort.


Eligibility criteria: Inclusion Criteria:

* Age range of the patients from 20-45 years old; able to read and sign the informed consent document, illiterate patient will be avoided.
* Patients able physically and psychologically to tolerate conventional restorative procedures.
* Patients with no active periodontal disease.
* Patients with thick gingival biotype.
* Patients with teeth problems indicated for full coverage restoration .
* Vital or non vital teeth.
* Good Oral hygiene.

Exclusion Criteria:

* Patients with poor oral hygiene.
* Patients with thin gingival biotype.
* Pregnant women.
* Unmotivated patients.
* Patients with gingival recession.
* Patients with psychiatric problems or unrealistic expectation .
* patient suffer from parafunctional habit .
* Smokers and heavy caffeine consumers.

Primary outcomes:
measure: Amount of lateral tissue displacement
timeFrame: through study completion,up to 24 weeks
Secondary outcomes:
measure: Amount of vertical tissue displacement
timeFrame: through study completion,up to 24 weeks
Other outcomes:
measure: Patient satisfaction
timeFrame: through study completion,up to 24 weeks
Locations:
city: Giza
country: Egypt
facility: Alaa Abdelzaher Abdelhamid Omara
Study officials:
References: