louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00400309: Safety of REPEVAX® Given One Month After REVAXIS®
Official title: A Double Blind, Controlled, Randomised, Clinical Study to Assess the Safety of Repevax® Administered One Month After Revaxis® or Placebo to Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Adult
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-11-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Primary objective:

* To describe the safety profile of a Tetanus, Diphtheria, Poliomyelitis and Pertussis vaccine (REPEVAX®) when administered as a pertussis booster 1 month after a Tetanus, Diphtheria, Poliomyelitis vaccine (REVAXIS®) as compared to the safety profile of REPEVAX® administered one month after Placebo.

Secondary objectives:

* To describe the safety of Td-IPV vaccine (REVAXIS®) or Placebo administered to healthy adults.
* To describe the safety of TdaP-IPV vaccine (REPEVAX®) administered one month after Td-IPV vaccine (REVAXIS®) or one month after Placebo.


Eligibility criteria: Inclusion Criteria:

* Healthy adult, with vaccination history (by written evidence) of a minimum of 5 doses of a tetanus, diphtheria and poliomyelitis containing vaccine as recommended in the French vaccination calendar at 18 years old, and a maximum of 8 doses.
* Last dose of a tetanus and/or diphtheria and/or poliomyelitis containing vaccine administered either alone or in combination at least 5 years prior to the administration of the first study vaccine.

Exclusion Criteria:

* Prior known hypersensitivity reaction to any diphtheria and/or tetanus and/or poliomyelitis and/or pertussis containing vaccine
* Any current (≤ 3 days) significant underlying disease or acute febrile illness (oral temperature ≥37.5°C)
* Known immunological deficiency
* Known malignant disease
* Known neurological disorder
* Any long-term (≥ 14 days) non steroid anti-inflammatory therapy given daily within the previous 30 days
* Known history of severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
* Any previous (≤ 90 days) administration of blood-derived products or immunoglobulins or scheduled to be administered through Visit 3
* Any recent administration (≤ 30 days) of a vaccine or scheduled vaccination

Primary outcomes:
measure: injection sites reactions and systemic events during the 7 day-safety period post-vaccination with TdaP-IPV vaccine.
timeFrame: 7 days
Secondary outcomes:
measure: injection-site adverse reactions and systemic adverse events during the 14 day-safety period post-vaccination with Td-IPV vaccine, TdaP-IPV vaccine and placebo and serious adverse events
timeFrame: 14 days
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
city: Lyon
country: France
city: Montpellier
country: France
city: Paris
country: France
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02408809: The Impact of Orthopaedic Smoking Cessation Education on Cigarette Abstinence Self-Efficacy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Keywords: Orthopaedic Smoking Cessation Discussion
Smoking Cessation
Randomized Controlled Trial
Lead sponsor: University of Missouri, Kansas City
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators of this study aim to evaluate the impact of a new orthopaedic related smoking cessation discussion on smoking behavior. Considering the high prevalence of patients who smoke and receive orthopaedic management, we are interested in determining whether an orthopaedic smoking cessation discussion impacts smoking abstinence self-efficacy over time compared to a general smoking cessation discussion.


Eligibility criteria: Inclusion Criteria:

* Daily cigarette smokers (5 cigarettes or more a day for past year), 18 years of age or older, new orthopaedic management, native English speaker

Exclusion Criteria:

* Patients unable to provide consent, suffer an impairment (mental, psychiatric, hearing or sight), alcohol and illicit drug abusers, homeless, presently managed with a smoking cessation medication or counseling, living with a cigarette smoker, user of other tobacco products

Primary outcomes:
measure: SASEQ
timeFrame: 5 minutes
Secondary outcomes:
measure: Patient Knowledge and Motivation to Quit
timeFrame: less than 20 minutes
Other outcomes:
Locations:
Study officials:
affiliation: UMKC DEPT OF ORTHOPAEDIC SURGERY
name: Nkem Egekeze, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMKC DEPT OF ORTHOPAEDIC SURGERY
name: Akin Cil, MD
role: STUDY_DIRECTOR
affiliation: UMKC DEPT OF BIOINFORMATICS
name: Karen Williams, PhD
role: STUDY_DIRECTOR
affiliation: UMKC DEPT OF ORTHOPAEDIC SURGERY
name: James Bogener, MD
role: STUDY_DIRECTOR
affiliation: UMKC DEPT OF ORTHOPAEDIC SURGERY
name: Mark Bernhardt, MD
role: STUDY_DIRECTOR
affiliation: UMKC DEPT OF ORTHOPAEDIC SURGERY
name: Jonathan Dubin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03678909: Cardiac Biomarkers in Patients With Single Ventricle Physiology
Official title: Cardiac Biomarkers in Patients With Single Ventricle Physiology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoplastic Left Heart
Congenital Heart Disease
Cyanotic Congenital Heart Disease
Cardiac Disease
Keywords: Troponin
BNP
Biomarkers
Hypoplastic Left Heart
Norwood
DKS
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2018-09-20
Enrollment: 19
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonate with Hypoplastic Left Heart Syndrome

Brief summary: All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and Troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule.

These cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via Sickbay.

Detailed description: All neonates with congenital heart disease undergoing stage one palliation (Norwood procedure, Damus-Kaye-Stansel procedure) at Texas Children's Hospital will be regularly monitored for B-type natriuretic peptide (BNP) and Troponin level before the surgical procedure, on arrival to the cardiac intensive care unit after their surgical procedure, every 6 hours during the first 24 hours of the post-operative period, followed by daily levels for the first week, and then weekly during patient's regular laboratory work up schedule.

These cardiac biomarkers are linked to demographic, hemodynamic, respiratory, pharmacological data available via Sickbay.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of Hypoplastic Left Heart Syndrome as congenital heart disease as a neonate

Exclusion Criteria:

Other diagnosis of congenital heart disease than Hypoplastic Left Heart Syndrome Patients older than 30 days

Primary outcomes:
measure: Mortality
timeFrame: 3- 6 months depending on second stage procedure
Secondary outcomes:
measure: NEC
timeFrame: 3- 6 months depending on second stage procedure
measure: Reintubation
timeFrame: 3- 6 months depending on second stage procedure
measure: Cath intervention
timeFrame: 3- 6 months depending on second stage procedure
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Marc M Anders, ND
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01914809: Micro Array Analysis in Preeclampsia
Official title: Micro Array Analysis in Preeclampsia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preeclampsia
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Preeclampsia is a frequent pathology. His etiology is doubtful.

Targets :

The study target is to identify a risk of preeclampsia group obtained with transcriptom analysis from circulating peripheric cells.

Design:

Multidisciplinary study (Gynaecology-Obstetric, Immunology, North CIC).

The study of the transcriptional history of peripheral blood cells of 2patients groups:

* A patient group with a preeclampsia before 34 SA
* A patient group with a normal pregnancy paired on main confusion factors. Blood sampling will be collected at the diagnosis and 8 weeks after delivery.

Results and perspectives

* Obtain a transcriptionnal signature of preeclampsia
* To identify new mechanism of the disease
* Identification of a specific transcriptom analysis with the comparison after delivery For long-term, the target is to identify risk patient in order to conduct easily preventive clinical trials in preeclamsia (primary prevention) and to consider a specific follow-up for risk patients.


Eligibility criteria: Inclusion Criteria:

* A prééclampsie (blood pressure superior to 140 mmHg and to 90 mmHg) and at least a cross of protein in the strip and/or more of 300mg / 24h after 20 LIMITED COMPANIES and before 34 limited companies.
* An informed consent signed by the patient will necessarily have to be obtained.
* Woman having been taken care during the pregnancy or at the time of the childbirth(delivery) by one of the participating teams to the current project.
* Caucasian Patient
* Wait primigeste and nullipare

Exclusion Criteria:

* Major Patient protected by the law.
* Patient deprived of freedom for administrative or judicial reasons.
* Patient not benefiting from a national insurance scheme.
* Refusal of the patient to participate in the study.
* Not Caucasian Patient
* Multipare Wait
* Multiple Pregnancy
* Existence of foetal deformation explaining a delay of growth or a foetal death in utero.
* Age 18 years and \> 40 years.
* Absence of written consent or impossibility to receive the written consent (language or understanding).

Primary outcomes:
measure: predictive markers of preeclampsia
timeFrame: 36 months
Secondary outcomes:
measure: analysis of placental transcriptional profile.
timeFrame: 36 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: LOIC MONDOLONI
role: STUDY_DIRECTOR
References:
Clinical trial NCT00306709: Take HEED (Healthy Eating and Exercise Decisions)
Official title: Take HEED (Healthy Eating and Exercise Decisions)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
behavior change
cultural adaptations
weight loss
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2006-03-24
Enrollment: 223
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a randomized intervention that examines the effect of culturally adapted weight loss program in African American (AA) females age 40-65. Evidence suggests that AA women are more successful with weight loss programs that are culturally tailored (Karanja, et al, 2002). Take HEED is a combination of 2 interventions, Therapeutic Lifestyle Changes Diet (TLC) from ATP-III and the CHANGE exercise program, which have shown success independently in previous clinical trials with AAs.

Detailed description: Project/study objective(s), This is a randomized intervention that examines the effect of culturally adapted weight loss program in African American (AA) females age 40-65. Evidence suggests that AA women are more successful with weight loss programs that are culturally tailored (Karanja, et al, 2002). Take HEED is a combination of 2 interventions, Therapeutic Lifestyle Changes Diet (TLC) from ATP-III and the CHANGE exercise program, which have shown success independently in previous clinical trials with AAs.

Methods, The 21 month program (6 months active intervention and 15 months maintenance) is provided by a Nurse matched with the study participants for race, age, and gender. Take HEED uses behavior change strategies (Prochaska et al 1992) which have been modified to include spirituality, AA cultural materials and examples woven into the lesson plans, and sustained peer support. The diet has been modified to include calorie reductions, increased fruit/ vegetable and calcium intake, incorporation of AA ethnic recipes. Exercise has been culturally adapted featuring line- dancing, brisk walking and includes socialization time for development of strong interpersonal bonds that will encourage exercise in the participants. The control group receives KP's usual care which is a combination of nutrition classes and web based learning.

Eligibility criteria: Inclusion Criteria:

* BMI greater than 30
* African American
* 40-46 years old

Exclusion Criteria:

- bariatric surgery within the previous 5 years

Primary outcomes:
measure: Examine the effect of culturally adapted weight loss program in African American (AA) females age 40-65
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Kaiser Pemanente
state: Ohio
Study officials:
affiliation: Kaiser Permanente
name: Pamala J Murphy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01890187: Repeatability and Reproducibility of Cirrus HD-OCT Measurements of Illumination Areas Under the Retinal Pigment Epithelium
Official title: Repeatability and Reproducibility of Cirrus HD-OCT Measurements of Illumination Areas Under the Retinal Pigment Epithelium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Dry AMD With Geographic Atrophy
Lead sponsor: Carl Zeiss Meditec, Inc.
Sponsor class: INDUSTRY
Collaborators: name: DataMed Devices Inc.
First posted: 2013-07-01
Enrollment: 85
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: The objective of this study is to determine the repeatability and reproducibility of the Cirrus HD-OCT measurement of illumination areas under the retinal pigment epithelium (RPE).

Detailed description: This is a prospective, single site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. The study will be divided into two phases. In Phase 1, the inter-device variability of Cirrus HD-OCT measurements of illumination areas under the RPE will be determined. In Phase 2, the inter-operator variability of Cirrus HD-OCT measurements of illumination areas under the RPE will be determined. In each of these phases, the Macular Cube 200 x 200 scan and the Macular Cube 512 x 128 scan will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Males or females 50 years of age and older diagnosed to have advanced dry AMD with geographic atrophy.
* Geographic atrophy lesions should:

  * Not be greater than 5 mm at the widest diameter. The entire lesion(s) should fit into the 6x6 mm scan area of the Cirrus HD-OCT.
  * Not be smaller than 1.25 mm2.
  * Not be confluent with peri-papillary atrophy.
  * Not be combined with other lesions such as CNV.
* Able and willing to make the required study visits.
* Able and willing to give consent and follow study instructions.

Exclusion Criteria:

* History of retinal surgery, laser photocoagulation, and/or radiation therapy to the eye.
* Evidence of other retinal diseases of the eye, including wet AMD, diabetic retinopathy, diabetic macular edema, or significant vitreomacular traction.
* Thick media opacity or inability to fixate that precludes obtaining acceptable scans.
* Concomitant use of hydrochloroquine or chloroquine.
* Unable to make the required study visits.
* Unable to give consent or follow study instructions.

Primary outcomes:
measure: Coefficient of variation for area of increased illumination under the RPE (mm^2)
timeFrame: Single visit observation
Secondary outcomes:
measure: Coefficient of variation of the closest distance to fovea
timeFrame: Single visit observation
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: West Coast Retina
state: California
Study officials:
affiliation: West Coast Retina
name: Brandon Lujan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06811987: Artificial Intelligence-Based Emergency Triage Education Tool in Enhancing Clinical Critical Thinking and Triage Practice
Official title: Instructor-led Artificial Intelligence-Based Emergency Triage Education Tool in Enhancing Clinical Critical Thinking and Triage Practice: Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nursing Teaching Pedagogy
Conversational AI Nursing Education Serious Game
Lead sponsor: Hong Kong Metropolitan University
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 350
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study aims to develop an artificial intelligence (AI) based emergency triage education tool for providing critical thinking and questioning skills training to nursing students. It also aims to contribute valuable implications by collecting the knowledge, attitudes, and compassion aspects of nursing students toward AI-based education

The objectives of the study:

1. To evaluate the effectiveness of instructor-led and self-play pedagogy approaches in enhancing students' critical thinking by an AI-based emergency triage education tool.
2. To evaluate the effectiveness of instructor-led and self-play pedagogy approaches in enhancing students' triage skill retention by an AI-based emergency triage education tool.
3. To evaluate students' learning motivation, simulation-based experience, and usability towards AI-based technology learning.

Participants will

1. play the education tool in different pedagogy approaches
2. answer the questionnaires and receive a qualitative interview


Eligibility criteria: Inclusion Criteria:

1. Aged 18 or above;
2. Currently studying the NURS 225F of the Bachelor of Nursing (General) at Hong Kong Metropolitan University;
3. Able to use electronic devices to accomplish an online survey and participate in the AI-based emergency triage education tool

Exclusion Criteria:

* Currently working in emergency department

Primary outcomes:
measure: Triage skill retention
timeFrame: Baseline, 1 month and 1 year
Secondary outcomes:
measure: Cognitive Engagement
timeFrame: Immediately post intervention
measure: Critical thinking
timeFrame: Base-line and 1 Month
measure: Self-rated critical thinking
timeFrame: Baseline, 1 month
measure: Usability
timeFrame: Immediately post intervention
measure: simulation-based experience
timeFrame: Immediately post intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00183287: Long Term Follow-Up of HIV Infected Patients Who Have Previously Participated in HIV Clinical Trials
Official title: Clinical, Virologic, and Immunologic Evaluation and Monitoring of Patients With Known or Suspected HIV Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2005-09-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected individuals who have previously participated in NIAID-funded HIV clinical trials

Brief summary: The purpose of this study is to monitor the progression of HIV infection and HIV-related disease processes in patients who have previously participated in HIV clinical trials.

Detailed description: Since 1982, the National Institute of Allergy and Infectious Diseases (NIAID) has been conducting numerous clinical trials on patients infected with HIV-1. Unfortunately, once clinical studies have closed or participants have reached a study endpoint, no additional follow-up data are collected regarding progression of HIV infection and development of HIV-related complications in these study participants. This study will collect long-term data for participants of previous NIAID-sponsored clinical trials to study HIV-related disease processes and complications, benefits and toxicities of investigational medications and vaccines, and medical management of participants with known or suspected HIV infection.

Study visits will occur every 6 months. A physical exam, blood collection, and medical history will occur at all visits. Depending on the need of participants, additional laboratory and diagnostic tests will be performed, and standard medical care will be provided.

Eligibility criteria: Inclusion Criteria:

* HIV infected
* Previously participated in a NIAID-funded clinical trial studying HIV disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Laboratory of Immunoregulation (LIR), NIAID
name: JoAnn M. Mican, MD
role: PRINCIPAL_INVESTIGATOR
References: