louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00558233: Effectiveness Study of a Computer-Based Colorectal Cancer Screening Decision Aid
Official title: Overcoming Literacy Barriers in Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Health Literacy
Keywords: Colorectal cancer
Screening
Health literacy
Patient education
Computer assisted instruction
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: University of North Carolina, Chapel Hill
First posted: 2007-11-14
Enrollment: 264
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether a multimedia educational computer program can increase colorectal cancer screening rates in low and adequate literacy patients.

Detailed description: Results will be stratified by low/marginal and adequate literacy as determined by the Rapid Estimate of Adult Literacy in Medicine instrument.

Eligibility criteria: Inclusion Criteria:

* English-speaking
* Scheduled to see an internal medicine provider
* No recent colorectal cancer screening

Exclusion Criteria:

* Personal history of colorectal cancer
* Family history of colorectal cancer
* Blood seen in stools within last month
* Obvious cognitive or physical impairment that would prevent participation

Primary outcomes:
measure: Receipt of colorectal cancer screening
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in participants' readiness to be screened (Stage of Change)
timeFrame: Day 1
measure: Self-reported intent to discuss colorectal cancer screening with healthcare provider
timeFrame: Day 1
measure: Provider ordering a colorectal cancer screening test
timeFrame: Day 1
measure: Participant completion of computer program without assistance
timeFrame: Day 1
measure: Participant acceptance of computer program
timeFrame: Day 1
measure: Number of polyps and cancers found by screening tests performed
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center; Downtown Health Plaza
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: David P Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miller DP Jr, Spangler JG, Case LD, Goff DC Jr, Singh S, Pignone MP. Effectiveness of a web-based colorectal cancer screening patient decision aid: a randomized controlled trial in a mixed-literacy population. Am J Prev Med. 2011 Jun;40(6):608-15. doi: 10.1016/j.amepre.2011.02.019.
Clinical trial NCT03312933: Associated Joint Pain With Controlled Ankle Movement (CAM) Walker Boot Wear
Official title: Associated Joint Pain With CAM Walking Boot Wear
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Ankle Injuries
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who were placed into a CAM walker boot for \>2 weeks were prospectively enrolled. Patients were placed by an orthopedic cast technician into either a tall or short CAM walker boot, based upon the appropriate boot type needed for treatment. Those who subsequently reported wearing the boot for less than two weeks or had a treatment plan change were removed from the study.

Demographic information was gathered, including age, sex, race or ethnicity, body mass index (BMI), history of lower extremity or lower back injury, history of chronic pain (e.g. fibromyalgia, chronic opiate use, chronic regional pain syndrome), and cigarette smoking history. The diagnosis was recorded for which the CAM walker boot was required.

Brief summary: This study evaluates the location, frequency and duration of secondary site pain relating to immobilization in a CAM walker boot.

Detailed description: Patients wearing a CAM walker boot for treatment of a foot or ankle injury were prospectively enrolled and evaluated for new or worsened secondary site pain. Surveys at four time points were completed to evaluate the presence of secondary site pain, its severity, and its impact on overall function.

Eligibility criteria: Inclusion Criteria:

* All patients enrolled in the study must have an injury that requires wear of a CAM walking boot for at least two weeks and have ambulation ad libitum without other aids (e.g crutches, canes, scooters, wheelchairs, etc.).

Exclusion Criteria:

* Patients will be excluded from the study if they are a recent post-operative patient for lower extremity injury, have an additional acute injury to a lower extremity or back other than the foot or ankle injury being treated by the CAM walking boot at the time of initiation of treatment, have an ongoing or history of lower extremity joint injury, arthritis, or back pain or have restricted weightbearing as instructed by a physician (i.e. for ankle fracture that cannot weightbear).

Primary outcomes:
measure: The Presence and Severity of Secondary Site Pain
timeFrame: At the time of transitioning out of the boot
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jeremy T Smith, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02140333: Erlotinib 100mg or 150mg in Treating EGFR Mutated NSCLC
Official title: Phase 3 Study of Erlotinib 100mg or 150mg in Treating EGFR Mutated Patients With Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: NSCLC
EGFR Mutation
Keywords: erlotinib
EGFR mutation
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2014-05-16
Enrollment: 220
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: The purpose of this study is to determine whether 100mg erlotinib had similar effect compared with 150mg erlotinib in NSCLC patients with EGFR mutation in China.

Detailed description: In China it was confirmed that 150mg Erlotinib was effective in NSCLC patients wtih EGFR mutation, but reducing dose occurring in some patients because of the drug related side-effects. Thus, we sought to investigate that in Chinese patients with EGFR mutation whether low dose (100mg) Erlotinib had similar efficacy but lower toxcities compared with standad dose (150mg) Erlotinib.

Eligibility criteria: Inclusion Criteria:

1. Histological diagnosis of NSCLC with phase IIIB or IV disease;
2. Sensitive mutation EGFR gene (18, 19 del, 21 L858R gene mutation) (mutation detection methods:ARMS-PCR, sequence method)
3. Never received anti-tumor therapies for the advanced stage;
4. Never used EGFR inhibitors;
5. Measurable disease by RECIST criteria;
6. Male or female patients \>=18 years of age;
7. ECOG karnofsky performance 0\~3, life expectancy is greater than 12 weeks;
8. Patients must be accessible for treatment and follow-up;

Exclusion Criteria:

1. Previously used EGFR inhibitors
2. Mix ingredients in patients with squamous cell carcinoma, small cell lung cancer;
3. Allergic to erlotinib;
4. Non-measurable lesions
5. Pregnant or lactating women;
6. Patients having other factors that preventing researchers from enrollment them.

Primary outcomes:
measure: Progression free survival
timeFrame: 2 years after the initial dose
Secondary outcomes:
measure: The objective response rate
timeFrame: Patients will be followed for an expected average of 6 months
Other outcomes:
measure: Overall survival
timeFrame: 3 year after the initial dose
measure: Adverse events
timeFrame: 1 year
Locations:
city: Guanzhou
country: China
facility: Guangzhou medical university
state: Guangdong
Study officials:
References:
Clinical trial NCT01940133: A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of PQR309
Official title: Phase I Study of Oral PQR309 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: PIQUR Therapeutics AG
Sponsor class: INDUSTRY
First posted: 2013-09-12
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a Phase I, open label study to determine the Maximum Tolerated Dose(MTD) and the Recommended Phase II Dose (RP2D) in patients with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced solid tumor for which no therapy of proven efficacy is available.
* Age ≥ 18
* Evidence of tumor progression with measurable or evaluable disease.
* Use of adequate contraceptive measures for male patients.
* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1.
* Signed informed consent.

Exclusion Criteria:

* Concomitant anticancer therapy (e.g., chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifier, signal transduction inhibitors)
* Patients with a history of myocardial infarction or coronary artery bypass within the last 3 years.
* Patients with severe/unstable angina, coronary/peripheral arterial bypass, symptomatic congestive heart failure NYHA Class 3 or 4, hypertension BP\>150/100mmHg.
* Pre-diagnosed diabetes mellitus.
* Fasting glucose \> 7.0 mmol/L or HbA1c \> 6%.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D)
timeFrame: In average 1 year
Secondary outcomes:
measure: To determine overall safety
timeFrame: 1 year
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Andreas Wicki, Dr.
role: STUDY_CHAIR
References:
citation: Wicki A, Brown N, Xyrafas A, Bize V, Hawle H, Berardi S, Cmiljanovic N, Cmiljanovic V, Stumm M, Dimitrijevic S, Herrmann R, Pretre V, Ritschard R, Tzankov A, Hess V, Childs A, Hierro C, Rodon J, Hess D, Joerger M, von Moos R, Sessa C, Kristeleit R. First-in human, phase 1, dose-escalation pharmacokinetic and pharmacodynamic study of the oral dual PI3K and mTORC1/2 inhibitor PQR309 in patients with advanced solid tumors (SAKK 67/13). Eur J Cancer. 2018 Jun;96:6-16. doi: 10.1016/j.ejca.2018.03.012. Epub 2018 Apr 13.
Clinical trial NCT02139033: A Phase 4 Study Investigating the Efficacy of Retaine™ in Managing Signs and Symptoms Associated With Dry Eye Syndrome
Official title: A Single-Center Evaluation of Retaine™ Ophthalmic Emulsion in the Management of Tear Film Stability and Ocular Surface Staining in Patients Diagnosed With Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Keratoconjunctivitis Sicca
Keywords: Dry Eye, Dry Eye Syndrome, Retaine, KCS, Keratoconjunctivitis sicca
Lead sponsor: Ocusoft, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2014-05-15
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy of Retaine™ ophthalmic emulsion in treating the signs and symptoms of dry eye syndrome.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent;
* Have a reported history of dry eye;
* Have a history of use or desire to use eye drops;

Exclusion Criteria:

* Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* Have used Restasis® within 30 days of Visit 1;
* Be a woman who is pregnant, nursing or planning a pregnancy;
* Be unwilling to submit a urine pregnancy test if of childbearing potential;
* Have a known allergy and/or sensitivity to the test article or its components;
* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1.

Primary outcomes:
measure: Tear Film Break-Up Time
timeFrame: Day 15
measure: Ocular surface damage as measured by fluorescein staining
timeFrame: Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
state: Massachusetts
Study officials:
References:
Clinical trial NCT05147233: OCS-01: a Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Official title: OCS-01: a Phase 3 Study Evaluating the Efficacy and Safety of OCS-01 Eyedrops Compared to Vehicle for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Disorders of the Eye Following Cataract Surgery
Lead sponsor: Oculis
Sponsor class: INDUSTRY
First posted: 2021-12-07
Enrollment: 241
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: The purpose of this study is to evaluate the efficacy and safety of OCS-01 Ophthalmic Suspension versus placebo (vehicle) in the treatment of inflammation and pain following cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Be planning to undergo unilateral cataract extraction via phacoemulsification and posterior chamber intraocular lens (PCIOL) implantation in the study eye;
* Have a pin-hole visual acuity (VA) without any other correction \> 20 letters (approximately 20/400) in the operative eye and \> 35 letters (approximately 20/200) in the fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at Visit 1 (Day -1 to Day -28 \[prior to surgery\]).

Exclusion Criteria:

* Have any intraocular inflammation (e.g. white blood cells or flare)present in either eye at the Visit 1 (Day -1 to Day -28 \[prior to surgery\]) slit lamp examination;
* Have a score \> 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 \[prior to surgery\]) in the study eye.

Primary outcomes:
measure: Number of Participants With an Absence of Anterior Chamber Inflammation
timeFrame: Day 15
measure: Number of Participants With an Absence of Ocular Pain
timeFrame: Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Oculis Investigative Site
state: Texas
Study officials:
affiliation: Study Principal Investigator
name: Oculis Investigative Site
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06611033: A Study of V118 Formulation C (V118C) in Healthy Participants (V118C-001)
Official title: A Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V118 Formulation C in Healthy Adults
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-09-24
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to learn how safe V118 Formulation C is in Healthy Adults and how well people tolerate it.


Eligibility criteria: The main inclusion criteria include but are not limited to the following:

* Is in good health before randomization

Exclusion Criteria:

* Has a history of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years prior to receiving study vaccination.
* Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.

Primary outcomes:
measure: Number of Participants with Solicited Injection Site Adverse Events (AEs)
timeFrame: Up to approximately 7 days after each vaccination
measure: Number of Participants with Solicited Systemic AEs
timeFrame: Up to approximately 7 days after each vaccination
measure: Number of Participants with Immediate AEs Following Vaccination
timeFrame: Up to approximately 30 minutes after each vaccination
measure: Number of Participants with Unsolicited AEs
timeFrame: Up to approximately 28 days after each vaccination
measure: Number of Participants With a Serious Adverse Event (SAE)
timeFrame: Up to approximately 12 months after final vaccination
measure: Number of Participants with a Medically Attended Adverse Event (MAAE)
timeFrame: Up to approximately 12 months after final vaccination
measure: Number of Participants with an Event of Clinical Interest (ECI)
timeFrame: Up to approximately 12 months after final vaccination
Secondary outcomes:
measure: Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs)
timeFrame: Day 28 postvaccination
Other outcomes:
Locations:
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach ( Site 0003)
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America ( Hollywood ) ( Site 0002)
state: Florida
city: Galveston
country: United States
facility: University of Texas Medical Branch ( Site 0001)
state: Texas
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03286933: Yoga Therapy for Adolescents With Juvenile Idiopathic Arthritis
Official title: Yoga Therapy for Adolescents With Juvenile Idiopathic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Juvenile Idiopathic Arthritis
Yoga Therapy
Keywords: yoga therapy
JIA
quality of life
pain management
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2017-09-19
Enrollment: 10
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to better understand the effects of a yoga program on adolescents with juvenile idiopathic arthritis (JIA). The investigators want to learn whether or not a yoga therapy based program will decrease pain and improve quality of life in patients with JIA.

This is an 8-week program with home program of online videos.

Detailed description: This is an 8-week program consisting of weekly yoga therapy classes in a public studio. The classes are led by a pediatric occupational therapist who is also a certified internationally accredited yoga therapist (C-IAYT). The initial and final sessions will include an Rheumatologist MD evaluation including a physician global assessment and joint damage assessment (JADI) and visual assessment (VAS). A Visual Analog Pain Scale will and Peds Quality of Life Questionnaire-Arthritis Module 4.0 will be administered. Each yoga class is 75 minutes to include a set-sequence of postures including breathing exercises and final corpse pose (final relaxation).

Eligibility criteria: Inclusion Criteria:

* Adolescents with formal diagnosis of JIA, speak and understand English, can get on/off floor independently.

Exclusion Criteria:

* Dependent on assistive device for ambulation; does not understand English, does not have a diagnosis of JIA.

Primary outcomes:
measure: Peds QL-Arthritis Module 4.0
timeFrame: 8 weeks
measure: Visual Analog Pain Scale
timeFrame: 8 weeks
measure: Visual Assessment
timeFrame: 8 weeks
measure: Joint Damage Assessment (JADI)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
References:
Clinical trial NCT02989233: Impact of Three Different Education Methods on Oral Hygiene
Official title: Impact of Three Different Education Methods on Oral Hygiene and Theoretical Knowledge of Schoolchildren
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Oral Hygiene
Lead sponsor: Bulent Ecevit University
Sponsor class: OTHER
First posted: 2016-12-12
Enrollment: 144
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the present study, 144 children (72 males and 72 females), whose ages ranged between 8-13, were divided into 12 equal experimental groups according to their ages and gender. They were all considered to have poor hygiene. Only one out of the three different education methods (brochure, model or video) was applied to each group. The percentage change in PI, GI, BOP and theoretical test points from the baseline to the 6th months were evaluated.

Detailed description: Aim: The aim the present study was to evaluate the impact of three different education methods on the oral hygiene levels of school children using clinical and theoretical findings.

Methods: In the present study, 144 children (72 males and 72 females), whose ages ranged between 8-13, were divided into 12 equal experimental groups according to their ages and gender. They were all considered to have poor hygiene. Only one out of the three different education methods (brochure, model or video) was applied to each group. The percentage change in PI, GI, BOP and theoretical test points from the baseline to the 6th months were evaluated. The data was statistically analysed by using Kolmogorov-Smirnov and One-way ANOVA tests.

Eligibility criteria: Inclusion Criteria:

* According to the Simplified Oral Hygiene Index, the patients having the score of 2 and over were accepted.

Exclusion Criteria:

* According to the Simplified Oral Hygiene Index, the patients having the score under 2 were not included in the study

Primary outcomes:
measure: Theoretical Test Application
timeFrame: Baseline and 6 months after treatment
Secondary outcomes:
measure: Gingival index
timeFrame: Baseline and 6 months after treatment
measure: Plaque index
timeFrame: Baseline and 6 months after treatment
measure: Bleeding on probing
timeFrame: Baseline and 6 months after treatment
Other outcomes:
Locations:
Study officials:
References: