louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02986360: Informed Implementation of Breast Density Reporting
Official title: Informed Implementation of Breast Density Reporting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Density, Breast Cancer Prevention
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 500
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 1. To develop brief informational videos, Vidscrips, that can be sent to women following their mammogram to provide personalized information that integrates breast density with overall breast cancer risk, and provides information about additional care recommendations and talking tips for conversations with the health care providers.
2. To test the effectiveness of this tool in a trial of 300 women undergoing mammography. The investigators hypothesize that individuals in the intervention arm (vs. those in the standard care arm who receive a letter with the language required by the legislation) will have more accurate knowledge of their overall risk of breast cancer, their Mammographic Breast Density (MBD) result, more appropriate observed and intended use of additional screening \[i.e., use of screening Magnetic Resonance Imaging (MRI) will be reserved only for women at high risk of breast cancer\], better satisfaction with their episode of breast cancer screening, less decisional conflict about their personal decision for any additional evaluation, and less worry about breast cancer.


Eligibility criteria: Inclusion Criteria:

* undergoing screening mammography at participating hospital facility
* normal mammogram result
* no prior history of Ductal carcinoma in situ (DCIS) or invasive breast cancer
* must have email account

Exclusion Criteria:

* non-English speaking
* prior history of Ductal Carcinoma in situ (DCIS) or invasive breast cancer
* no email

Primary outcomes:
measure: Knowledge of overall breast cancer risk
timeFrame: 1 month
measure: Knowledge of breast density
timeFrame: 1 month
Secondary outcomes:
measure: Observed use of additional screening
timeFrame: 9 months of index mammogram
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: Jennifer S Haas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haas JS, Giess CS, Harris KA, Ansolabehere J, Kaplan CP. Randomized Trial of Personalized Breast Density and Breast Cancer Risk Notification. J Gen Intern Med. 2019 Apr;34(4):591-597. doi: 10.1007/s11606-018-4622-4. Epub 2018 Aug 8.
Clinical trial NCT00750360: Study to Monitor the Safety and Reactogenicity of Fluarix™ in Korean Subjects Aged > 6 Months of Age.
Official title: Study to Monitor the Safety and Reactogenicity of GlaxoSmithKline Biologicals' Influenza Split Vaccine FLUARIX™ Administered According to the Prescribing Information in Korean Subjects Aged More Than 6 Months of Age at the Time of Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza
Korea
FluarixTM
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-09-10
Enrollment: 883
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study collects data on safety and reactogenicity of the vaccine in the local target population (600 or more subjects) as per the requirement of Korean Food and Drugs Administration (KFDA).


Eligibility criteria: Inclusion Criteria:

* A male or female \> 6 months of age at the time of the first vaccination.
* Subjects who the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
* Free of obvious health problems as established by medical history and clinical examination judged by the investigator before entering into the study.
* If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after vaccination.

Exclusion Criteria:

* Clinical signs of acute febrile illness at the time of entry into the study.
* Any treatment with immunosuppressive drugs, including oral and parenteral corticosteroids.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or previous severe reaction to influenza virus vaccine.

Primary outcomes:
measure: Number of Participants Reporting Severe Unsolicited Adverse Events
timeFrame: During the 21-day follow-up period (Day 0 to Day 20) after vaccination
Secondary outcomes:
measure: Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged Less Than 72 Months.
timeFrame: During the 4-day follow up (Day 0 to 3) after vaccination.
measure: Number of Participants Reporting Solicited Local and General Adverse Events in Subjects Aged 72 Months and Older.
timeFrame: During the 4-day follow up (Day 0 to 3) after vaccination.
measure: Number of Participant Reporting Unsolicited Adverse Events.
timeFrame: During the 21-day follow-up period (Day 0 to Day 20) after vaccination
measure: Number of Participants Reporting Serious Adverse Events (SAE).
timeFrame: Within 1 month following vaccination
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00856960: The Effect of Hypertension Medications on Renal Blood Flow Measurements in Healthy Males (MK-0000-127)
Official title: A Randomized, Double-Blind, Placebo-Controlled, 4-Treatment, 3-Period, Incomplete Block, Balanced Crossover Study to Evaluate the Effects of a Single Dose of Aliskiren and Losartan on Renal Blood Flow Measurements in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect of Aliskiren and Losartan on renal blood flow using PAH clearance, PC MRA and ASL MRI methodologies.


Eligibility criteria: Inclusion Criteria:

* Subject is in generally good health
* Subject is willing to avoid unaccustomed strenuous exercise during the study
* Subject agrees to consume ONLY the study-specified diet during all domiciled periods
* Subject has been a non-smoker for at least 3 months prior to study
* Subject will refrain from smoking or using any tobacco products during the study
* Subject agrees to refrain from consuming alcohol or caffeine during the domiciled periods and agrees to limit alcohol and caffeine consumption throughout the study

Exclusion Criteria:

* Subject has contraindication to MRI scans
* Subject has a history of stroke, seizure, or major neurological disorders
* Subject uses illicit drugs or has a history of drug/alcohol abuse
* Subject has had major surgery, has donated or lost 1 unit of blood, or has been in another investigational study in the last 4 weeks
* Subject has a history of multiple and/or severe allergies to drugs or food

Primary outcomes:
measure: change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Aliskiren
timeFrame: 2-5 hours post dose of study drug
Secondary outcomes:
measure: change in renal plasma flow as measured by PAH clearance and on renal blood flow as measured by ASL MRI after single-dose Losartan
timeFrame: 2-5 hours post dose of study drug
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02192060: Efficacy of a Triclosan Formulation to Control the Initial Subgingival Biofilm Formation
Official title: Efficacy of a Triclosan Formulation to Control the Initial Subgingival Biofilm Formation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Plaque
Keywords: Biofilm
Triclosan
Crossover
Clinical trial
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2014-07-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The aim of the study is to compare the effect of a suspension containing Triclosan in dynamic of the subgingival biofilm formation versus a Placebo suspension. The initial subgingival biofilm formation will be evaluated by means of Plaque Free Zone (PFZ).

Detailed description: This is a double blind, cross over, randomized clinical trial. 28 volunteers will stop mechanical supragingiva biofilm removal measures for 96h following a complete scaling and polishing of the tooth surfaces. During this period they will be asked to rinse for one minute with a slurry of either a triclosan containing dentifice or a control without triclosan. Every 24h the presence of deposits will be registered with special atention to the presence of a plaque free zone between the apical border of the deposits and the gingival margin. Absence of deposits is scored 0, presence of deposits and plaque free zone =1 and presence of deposits and absence of plaque free zone =2 (MALISKA, A. N. et al. Measuring early plaque formation clinically. Oral health preventive dentistry, v. 4, p. 273-278, 2006). The prevalence of scores and the rate of changes from scores 0 and 1 into 2 will be evaluated for significance. Sample size was calculated taking the results from the study o MALISKA, AN (2006) as reference.

Eligibility criteria: Inclusion Criteria:

* age from 18 years;
* non-smokers;
* have good general health;
* present at least 20 natural teeth in the mouth, including the incisors, canines and premolars without restorations, crowns, gingival recession, anatomic defects, gingivitis e/or periodontitis.

Exclusion Criteria:

* positive history of using antibiotic e/or anti-inflammatory drugs in the month previous to the initial consultation;
* positive history of allergies at using Triclosan;
* pregnant or lactating patients;
* patients in use of fixed orthodontic appliance.

Primary outcomes:
measure: Presence of Plaque Free Zone
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Dentistry Faculty, Federal University of Rio Grande do Sul
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Rui V. Oppermann, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01538160: A Single and Low Dose of Recombinant Factor VIIa in Patients With Severe Factor XI Deficiency Undergoing Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemophilia C
Keywords: recombinant factor VIIa
factor XI deficiency
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-02-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Lately the investigators found that patients with severe factor XI deficiency and inhibitors could undergo major surgery with a single low dose of recombinant factor VIIa and tranexamic agent. These results encourage us to apply this treatment in clinical trial setting to patients with severe factor XI deficiency undergoing surgery instead of blood product.

Detailed description: Eligible patients will be those with severe factor XI deficiency who agree to participate in the study . The treatment does not apply to patients requiring coronary artery bypass or other vascular surgery.

Eligibility criteria: Inclusion Criteria:

* patients with severe factor XI deficiency who will give informed consent to participate in the study

Exclusion Criteria:

* patients with atherosclerosis disease i.e. unstable angina pectoris or recent stroke
* Patients who required aorto-coronary bypass or any vascular surgery

Primary outcomes:
measure: Improvement in prophylactic treatment by using single and low dose recombinant FVIIa in patients with severe FXI deficiency
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat -Gan
country: Israel
facility: Ophira Salomon
city: Ramat-Gan
country: Israel
facility: Sheba Medical Center
city: Tel Hashomer, Ramat-Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
citation: Salomon et al presented at ASH 2008 entitled
Clinical trial NCT02792660: Identification of Cerebrospinal Fluid With Injeq IQ-Needle During Paediatric Lumbar Puncture
Official title: Identification of Cerebrospinal Fluid With Injeq IQ-Needle During Paediatric Lumbar Puncture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Lumbar Puncture
Lead sponsor: Injeq Ltd
Sponsor class: INDUSTRY
First posted: 2016-06-07
Enrollment: 40
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is clinical feasibility study on the device performance with paediatric patients. The main objective is to validate the performance of investigational device in distinguishing and identifying the cerebrospinal fluid (CSF) inside the subarachnoid space during a lumbar puncture on paediatric patients.


Eligibility criteria: Inclusion Criteria:

* Children whose diagnosis or treatment plan requires lumbar puncture to acquire a CSF sample.
* Consent from the parents

Exclusion Criteria:

* Being a high risk patient (as determined by the investigator)
* Any contraindication to a common lumbar puncture apply also in the investigation

Primary outcomes:
measure: Number of true/false positive and true/false negative detections of cerebrospinal fluid marked in case report form
timeFrame: During lumbar puncture
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Vesa Eskola, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00286260: Levetiracetam for Painful Polyneuropathy
Official title: Double-blind, Randomised, Placebo-controlled Trial of the Effect of Levetiracetam on Painful Polyneuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Painful Polyneuropathy
Keywords: polyneuropathy
neuropathic pain
levetiracetam
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2006-02-03
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Polyneuropathy of different etiologies is often associated with pain. The standard treatment of this pain is anticonvulsants or antidepressants, but none of these treatment are effective or tolerable for all patients. Levetiracetam is a newer anticonvulsant and it is the hypothesis is that it could relieve neuropathic pain in polyneuropathy. This is a randomised, double-blind, placebo-controlled, cross-over trial on the effect of levetiracetam 3.000 mg/day on pain in polyneuropathy


Eligibility criteria: Inclusion Criteria:

* age 20 to 0 years
* painful symptoms of polyneuropathy for at least 6 months
* confirmed diagnosis of polyneuropathy
* baseline pain score of 4 or more (0 to 10 point scale)
* pain at least 4 days a week
* adequate anticonceptive treatment for women with childbearing potential
* informed consent

Exclusion Criteria:

* other cause of pain
* previous allergic reactions towards levetiracetam
* known adverse drug reactions on levetiracetam
* pregnancy
* severe disease
* inability to follow study protocol
* treatment with antidepressants, other anticonvulsants or opioids

Primary outcomes:
measure: Pain relief rated on a 0 to 10 point numeric rating scale (median value for last treatment week in each period)
timeFrame: Daily
Secondary outcomes:
measure: Pain rated on 0 to 10 point numeric rating scales
timeFrame: Daily
measure: Pain subtypes rated on 0 to 10 point numeric rating scales
timeFrame: Daily
measure: Bruch-evoked pain
timeFrame: Baseline and end of each treament period
measure: Pin-prick evoked pain
timeFrame: Baseline and end of each treatment period
measure: Cold evoked pain
timeFrame: Baseline and end of each treatment period
measure: Health related quality of life(SF-36)
timeFrame: Baseline and end of each treatment period
measure: Pain related sleep disturbance
timeFrame: Daily
measure: Use of escape medication
timeFrame: Daily
Other outcomes:
Locations:
city: Odense C
country: Denmark
facility: Department of Neurology, Odense University Hospital
Study officials:
affiliation: Department of Neurology, Odense Unviersity Hospital
name: Søren H Sindrup, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01055860: One Year Outcome After Robotic Assisted Laparoscopic Sacral Colpopexy, a Case Series Review
Official title: One Year Outcome After Robotic Assisted Laparoscopic Sacral Colpopexy, a Case Series Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Urinary Incontinence
Keywords: uterine Prolapse
vaginal prolapse
mesh erosion
urinary incontinence
bowel symptoms
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2010-01-26
Enrollment: 75
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our study population will be women who underwent Robotic assisted laparoscopic sacral colpopexy at the Morristown Memorial Hospital for correction of pelvic organ prolapse using a synthetic polypropylene mesh.

Brief summary: Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce in regard to its long-term outcomes. This advanced procedure is offered at MMH through the Urogynecology division. The Investigators setup to review the one year outcome of patients who underwent this procedure using a polypropylene mesh. These outcomes will include anatomical and quality of life measures.


Eligibility criteria: Inclusion Criteria:

* Any Robotic assisted laparoscopic sacral colpopexy with polypropylene mesh during the study period

Exclusion Criteria:

* Other graft material than polypropylene.
* Enrollment in a different study.

Primary outcomes:
measure: 1. Objective anatomic outcomes We will use the pelvic organ prolapse quantification system (POP-Q). Objective surgical failure will be defined as any prolapse at or beyond the introitus
timeFrame: one year
Secondary outcomes:
measure: 2. Prolapse Specific Quality of Life Patients will complete a prolapse specific quality of life instrument prior to and one year after surgery. (PFIQ-7)
timeFrame: one year
measure: 3. Pelvic organ prolapse related symptoms (PFDI-20)
timeFrame: one year
measure: 4. Graft-related complications Rates of graft erosion into adjacent organs such as bowel, bladder or vagina - during the study period will be reported.
timeFrame: one year
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Atlantic Health Urogynecology
state: New Jersey
Study officials:
affiliation: Atlantic Health System
name: Patrick Culligan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00933660: Retention and Retrieval for Three Different Training Methods
Official title: Do we Need an Instructor, or a Manikin to Learn BLS/AED, or is Web Based Training as Good as Instructor Based Training?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Improvement of BLS/AED Training Methods
Keywords: Education
Retention
Retrieval
Lead sponsor: Doczero
Sponsor class: OTHER
Collaborators: name: Ambulance Oost
First posted: 2009-07-07
Enrollment: 280
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The hypotheses that will be studied are:

H0: Providers trained by a web based application for skill competency in basic life support (BLS) and automated external defibrillation (AED) are as competent as those who were trained by certified instructors using the European Resuscitation Council (ERC) curriculum

H00-1: Providers who trained themselves with the used of web based training are more competent when they had a personal manikin for home exercise compared to providers who trained themselves with only a web based training

H0-2: Providers who did not receive any training will score lower than those who did.

Research questions for this study are:

1. What are the results in skill competency for non trained people?
2. What are the results in skill competency for trained people immediately after training?
3. What is the retention of skills for trained and non trained people after six months?


Eligibility criteria: Inclusion Criteria:

* willing to follow a BLS/AED course

Exclusion Criteria:

* CPR training within the last five years
* professional health care provider

Primary outcomes:
measure: Kruskal-Wallis
timeFrame: 10-2007 - 03-2009
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Doczero
name: Wiebe de Vries, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Koenraad Monsieurs, Professor
role: STUDY_CHAIR
affiliation: VU Medical Centre
name: Joost Bierens, Professor
role: STUDY_DIRECTOR
affiliation: Academical Medical Centre Amsterdam
name: Rudolph Koster, PhD
role: STUDY_CHAIR
References: