louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04478110: Korean CRC Screening Study PT13599
Official title: Community-Based Participatory Intervention to Improve Colorectal Cancer Screening Among Under-Served Korean Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-07-20
Enrollment: 925
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Korean Americans report the lowest and declined rates of colorectal cancer (CRC) screening, compared to general population in the United States. The present study aimed to evaluate the efficacy of a community-based multifaceted intervention designed to improve CRC screening among Korean Americans.


Eligibility criteria: Inclusion Criteria:

* Participants were eligible to participate in this study if they:

  1. were self-identified Korean Americans;
  2. were 50 years and older;
  3. did not have a colorectal polyp, CRC cancer, or a family history of CRC (first degree relative); and
  4. non-adherent to CRC screening guidelines (never had any CRC screening or were overdue for screening).

     Exclusion Criteria:

Primary outcomes:
measure: CRC screening rates
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Asian Health, Lewis Katz School of Medicine, Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Grace X Ma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ma GX, Lee M, Beeber M, Das R, Feng Z, Wang MQ, Tan Y, Zhu L, Navder K, Shireman TI, Siu P, Rhee J, Nguyen MT. Community-Clinical Linkage Intervention to Improve Colorectal Cancer Screening Among Underserved Korean Americans. Cancer Health Disparities. 2019;3:e1-e15. Epub 2019 Aug 19.
Clinical trial NCT01264510: Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha)
Official title: The Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha) in Patients With Conductive or Mixed Hearing Loss, or Unilateral Deafness
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Conductive Hearing Loss
Mixed Hearing Loss
Unilateral Deafness
Keywords: conductive hearing loss
mixed hearing loss
unilateral deafness
implanted with Baha
conductive or mixed hearing loss implanted with a Baha or
unilateral deafness implanted with a Baha
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2010-12-21
Enrollment: 0
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: A bone-anchored hearing aid (Baha) consists of a titanium implant located at the mastoid, and a sound processor connected with the implant. The sound processor delivers bone conducted stimuli to the cochlea, bypassing the outer and middle ear.

Some patients who are unable to wear or do not benefit from a conventional air-conduction hearing aid, are candidate for a Baha. Typically, these patients suffer from a conductive or a mixed hearing loss. Recently however, Baha's are also being recommended in patients with unilateral deafness. Sound coming from the deaf side is captured and transmitted through bone conduction to the normal inner ear. The overall benefit of a Baha is more difficult to assess in those patients.

Therefore, the goal of the current study is to examine the benefit of a Baha in patients with different audiological profiles (unilateral or bilateral conductive or mixed hearing loss, and unilateral deafness). Special attention will be given to predictive determinants of the benefit with a Baha, and to the improvement of pre-operative criteria and counseling of patients.


Eligibility criteria: Inclusion Criteria:

* Patients (males and females) already implanted with a bone-anchored hearing aid (Baha) are included in the study.
* Only patients above 18 years will be included.

Primary outcomes:
measure: benefit of a Bone-anchored hearing aid (Baha) in patients with different audiological profiles
timeFrame: after 3 months up to 10 years
Secondary outcomes:
measure: evaluation of subjective benefit of the Baha
timeFrame: after 3 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Ingeborg Dhooge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01454310: An Acellular Epithelial Skin Substitute in Deep Partial-thickness Burns
Official title: A Prospective Noninferiority Trial to Compare an Acellular Epithelial Skin Substitute With Autologous Split-thickness Skin Grafts in Deep Partial-thickness Burns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wound Healing
Scar Formation
Keywords: Skin substitutes
Split-thickness skin graft
Burn wound
Scar formation
Skin quality
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2011-10-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare an acellular epithelial skin substitute with autologous split-thickness skin grafts (STSGs) in deep partial-thickness burns. The objective is to evaluate skin quality and scar formation by using subjective and objective burn scar assessments in order to present valuable data for another additional option of wound coverage in deep partial-thickness burns. The investigators hypothesized that the acellular epithelial skin substitute is at least not inferior to autologous skin grafts.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years of age
* verified deep partial-thickness burns
* early tangential excision of burn wound (3-5 days after trauma)

Exclusion Criteria:

* Pregnancy
* ABSI-Score \>13
* Active tumor or immune-mediated disease
* Patient refusal

Primary outcomes:
measure: Time (in days +/- standarddeviation) to complete re-epithelialisation in acellular skin substitue area versus autologous skin
timeFrame: 1 year
Secondary outcomes:
measure: Skin quality- ratio acellular skin substitute/healthy skin versus ratio autologous skin/healthy skin
timeFrame: 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Burn Center, Department of Plastic and Reconstructive Surgery
Study officials:
affiliation: Medical University of Vienna
name: Lars P Kamolz, MD, PhD, MSc
role: STUDY_CHAIR
affiliation: Medical University of Vienna, Department of Plastic and Reconstructive Surgery
name: Maike Keck, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Uhlig C, Rapp M, Hartmann B, Hierlemann H, Planck H, Dittel KK. Suprathel-an innovative, resorbable skin substitute for the treatment of burn victims. Burns. 2007 Mar;33(2):221-9. doi: 10.1016/j.burns.2006.04.024. Epub 2006 Nov 2.
Clinical trial NCT04175210: Prospective Randomized Study of Accelerated Radiation Therapy (PRART)
Official title: Prospective Randomized Study of Accelerated Radiation Therapy (PRART) : A Non-Inferiority Trial to Compare Breast Cosmesis and Local Control After Concomitant Boost Breast Radiotherapy With Fifteen Fractions in Three Weeks (Arm 1, Standard) Versus Ten Fractions in Two Weeks (Arm 2, Experimental)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 400
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with Stage 0 ductal carcinoma in situ (Tis (DCIS), Stage T1-T2, lymph node negative(N0) breast cancers will be randomized to receive whole breast radiotherapy with a concomitant boost to the tumor bed over 15 fractions (Arm 1, standard) versus 10 fractions (Arm 2, experimental).


Eligibility criteria: Inclusion Criteria:

* Women status post segmental mastectomy
* If unilateral, pT1-2 breast cancer excised with negative margins
* If bilateral, pT1-2 breast cancer excised with negative margins AND/OR pTis excised with negative margins.
* Clinically N0 or pN0 or sentinel node negative
* Ductal carcinoma in situ DCIS with negative margins (no DCIS on inked margins).

Exclusion Criteria:

* Previous radiation therapy to the ipsilateral breast.
* 90 days from last surgery, unless s/p adjuvant chemotherapy
* 60 days from last chemotherapy
* Male breast cancer

Primary outcomes:
measure: Proportions of patients with adverse cosmetic outcomes
timeFrame: up to 2 years
Secondary outcomes:
measure: Number of participants who demonstrate local control at 5 year follow up
timeFrame: 5 years
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian Hospital at Lower Manhattan Cancer Center
state: New York
city: New York
country: United States
facility: Brooklyn Methodist Hospital - NewYork Presbyterian
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Queens
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Silvia Formenti, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00686010: Efficacy and Safety of JTT-705 300, 600 And 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia
Official title: A 4-Weeks Treatment, Randomised, Double-Blind, Parallel-Group Study Evaluating The Efficacy and Safety of JTT-705 300 to 900mg in Comparison With Placebo in Patients With Type II Hyperlipidaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type II Hyperlipidaemia
Keywords: CETP Inhibitor
HDL-C
LDL-C
Apolipoprotein
Lead sponsor: Japan Tobacco Inc.
Sponsor class: INDUSTRY
First posted: 2008-05-29
Enrollment: 198
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate the effect of JTT-705 doses from 300 mg to 900 mg on the elevation of HDL-C and on the inhibition of CETP activity versus placebo, in patients presenting with mild dyslipidaemia. These objectives will be tested after 4 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with of Type II hyperlipidaemia
* Patients having lipid values as indicated below:

  * HDL-C \< 1.6 mmol/l
  * TG \< 4.5 mmol/l
* Male and females between 18 and 65 years old (If female must be post-menopausal, or pre-menopausal and surgically sterile or using an acceptable form of contraception)

Exclusion Criteria:

* Body Mass Index (BMI) \> 35 kg/m²
* Pregnant, breast feeding, or woman with child bearing potential without an effective method of contraception
* Concomitant use of medications identified in the protocol

Primary outcomes:
measure: %change from baseline in HDL-C, Inhibition of CETP activity
timeFrame: 4-weeks
Secondary outcomes:
measure: %change from baseline in LDL-C and TC/HDL ratio
timeFrame: 4-weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam, Utrecht, Rotterdam, Nijmegen, Arnhem, Groningen, Dordrecht, Hoorn, Groningen
Study officials:
References:
Clinical trial NCT03811210: Using the Norm Range to Predict the Effect of Food Portion Size Reductions on Compensation Over 5 Days
Official title: Using the Norm Range to Predict the Effect of Food Portion Size Reductions on Compensation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Portion Size
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: Medical Research Council
First posted: 2019-01-22
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Reducing food portion size is a potential strategy to reduce energy intake. However it is unclear at what point consumers compensate for reductions in portion size by increasing energy intake from other items. This could result in no overall benefit of reducing food portion sizes. The investigators tested the hypothesis that reductions to the portion size of components of a main meal will only result in significant compensatory eating when the reduced portion size is no longer visually perceived as 'normal'. In a crossover experiment, participants were served different sized portions during lunch and dinner over 5 days: a 'large-normal', a 'small-normal', and a 'smaller than normal' portion. Intake from all other meal components consumed in the laboratory were measured.


Eligibility criteria: Inclusion Criteria:

* willing to consume the test foods
* BMI between 22.5 - 32.5

Exclusion Criteria:

* food allergies, intolerances or specific dietary requirements (including being vegetarian or vegan)
* history of eating disorders
* taking medication which affected appetite
* participated in a portion size studies in the past 12 months, or in dieting or weight loss trials in the past 4 weeks

Primary outcomes:
measure: Acute compensatory energy intake
timeFrame: Immediate (within single meal occasion)
measure: Total meal energy intake
timeFrame: Immediate (within single meal occasion)
measure: Total daily energy intake
timeFrame: Over 5 x full days
Secondary outcomes:
measure: Moderate-vigorous physical activity
timeFrame: Over 5 x full days
measure: Discretionary Leisure-time physical activity
timeFrame: Over 5 x full days
measure: Appetite
timeFrame: Over 5 x full days (measured before and after each meal occasion)
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Ashleigh Haynes
state: Merseyside
Study officials:
References:
citation: Haynes A, Hardman CA, Halford JCG, Jebb SA, Mead BR, Robinson E. Reductions to main meal portion sizes reduce daily energy intake regardless of perceived normality of portion size: a 5 day cross-over laboratory experiment. Int J Behav Nutr Phys Act. 2020 Feb 12;17(1):21. doi: 10.1186/s12966-020-0920-4.
Clinical trial NCT05241210: Real-Time Feedback (RTFB) to Improve Colonoscopy
Official title: Real-Time Feedback (RTFB) to Improve Colonoscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Johns Hopkins University
First posted: 2022-02-15
Enrollment: 4150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Multiple successive arms testing new feedback options
Primary purpose: TREATMENT

Brief summary: To test whether real-time feedback will improve quality of endoscopic examination.


Eligibility criteria: Inclusion Criteria:

- Any endoscopist willing to parcipate and performing routine colonscopy

Exclusion Criteria:

- No exclusion criteria

Primary outcomes:
measure: Adenoma Detection Rate
timeFrame: 5 months post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: UMN
name: Piet de Groen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02590510: Different Dose of Methotrexate for the Treatment of Meningeal Carcinomatosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Meningeal Carcinomatosis
Keywords: Intrathecal chemotherapy
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to compare the effect of 10 mg and 15 mg methotrexate in the treatment of meningeal carcinomatosis.


Eligibility criteria: Inclusion Criteria:

* age 14 or more
* a history of solid tumor
* a new clinical neurological signs and symptoms
* a typical CT(Computerized Tomography,CT) or MRI(Magnetic Resonance Imaging,MRI) imaging findings
* tumor cells in cerebrospinal fluid

Exclusion Criteria:

* KPS score \<60
* the tumor patients with organ failure
* bacteria, fungi or viral meningitis

Primary outcomes:
measure: overall survival
timeFrame: one year
Secondary outcomes:
measure: The incidence of adverse reactions
timeFrame: one year
measure: KPS score
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: The Second Hospital of Hebei Medical University
name: Hui
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03787810: Left Ventricular Dysfunction in Critically Ill Patients
Official title: Left Ventricular Dysfunction in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Ventricular Dysfunction
Critically Ill
Acute Coronary Syndrome
Cardiomyopathies
Takotsubo Cardiomyopathy
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: General ICU population

Brief summary: Left ventricular dysfunction is common in the critically ill. The aim of this study is to assess the incidence and prognosis of left ventricular dysfunction in critically ill patients.

Detailed description: Left ventricular dysfunction is common in the critically ill. A number of conditions can cause left ventricular dysfunction including myocardial infarction, septic cardiomyopathy, post resuscitation syndrome, takotsubo syndrome etc. A number of studies have assessed cardiac dysfunction in specific conditions (e.g. sepsis, cardiac arrest) but only a few studies have assessed cardiac dysfunction in a general ICU-population. The study will focus on diagnostics of the different types of cardiomyopathy and differentiating between ischemic and non-ischemic left ventricular dysfunction in a general ICU population. The aim of this study is to assess the incidence and prognosis of the different types of left ventricular dysfunction in critically ill patients. Our hypothesis is that left ventricular dysfunction is common in the critically ill and is associated with an increased risk of short-term death.

Eligibility criteria: Inclusion Criteria:

* Admitted within 24 hours to the ICU
* Dysfunction of at least one organ system, defined as at least +1 point in SOFA-score.

Exclusion Criteria

-

Primary outcomes:
measure: Mortality
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
state: Västra Götalandsregionen
Study officials:
affiliation: Sahlgrenska Academy, University of Gothenburg
name: Jonatan Oras, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05754710: Korea Xeljanz Post-marketing Surveillance for Juvenile Idiopathic Arthritis
Official title: Korean Post-marketing Surveillance for Xeljanz® 5 mg Film-coated Tablets and Xeljanz® 1 mg/mL Oral Solution in Patients With Active pJIA and jPsA
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Psoriatic Arthritis, Juvenile
Polyarticular Juvenile Idiopathic Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-03-06
Enrollment: 375
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with active polyarticular Juvenile Idiopathic Arthritis or juvenile Psoriatic Arthritis who are administered Xeljanz according to the approved label in Korea.

Brief summary: This study is to assess the safety and effectiveness of Xeljanz in Juvenile Idiopathic Arthritis (JIA) patients in routine clinical practice in Korea. JIA patients experience persistent joint pain, swelling and stiffness. This is a prospective observational study.

Xeljanz is a JAK inhibitor. It was first approved in 2014 for rheumatoid arthritis patients in Korea. The ministry of Food and Drug Safety in Korea mandates for a drug manufacturer to report the post-marketing surveillance after drug's approval or indication extension. This study is to see the safety and effectiveness of Xeljanz in Juvenile Idiopathic Arthritis patients in routine clinical practice in Korea.

This study is seeking patients who:

* Are 2 to less than 18 years of age;
* Are given Xeljanz for the treatment of JIA.

The study sponsor will monitor patients' treatment experience for up to 44 weeks. This will help assess the safety and effects of this study medicine.


Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. Pediatric subjects aged from 2 years to less than 18 years
2. Xeljanz administered according to efficacy/effectiveness on the approved labeling
3. Patients who will administer Xeljanz based on the medical judgement of the investigator
4. Evidence of a personally signed and dated informed consent document indicating that the subject (and a legally acceptable representative) has been informed of all pertinent aspects of the study

Exclusion Criteria:

Subjects meeting any of the following criteria will not be included in the study:

1) Subjects who are contraindicated from taking Xeljanz according to approved labeling\*

\*Refer to most recently approved label

Primary outcomes:
measure: Number of patients with treatment emergent treatment-related adverse events
timeFrame: Maximum of 12 months from the time of first administration of Xeljanz
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: