louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05409040: Health Promoting Lifestyle Behaviors
Official title: Health Promoting Lifestyle Behaviors and Associated Factors Among Sohag University Students
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy Life Style
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: under graduate students of Sohag university selected randomly from 4 faculties during their academic year 2022/2023

Brief summary: Assess the Health-promoting Lifestyle behaviors of Sohag University students. Identify socio-demographic determinants of the Health-promoting Lifestyle behaviors

Detailed description: Health is the most fundamental criterion on which man's life is dependent, and it has always been an issue throughout history. Health, according to a definition by the World Health Organization (WHO), is physical, spiritual, mental, social, emotional, and occupational tranquility, and not just the absence of illness. This definition, moreover, has been reintroduced as "people's social and economic potency and dynamicity".

Lifestyle is one of the most important determinants of health promotion that is influenced by cultural, economic, political and religious factors. Lifestyle includes day-to-day behaviors and functions of individuals in job, activities, fun, and diet.

According to WHO, 60% of related factors to individual health and quality of life are correlated to lifestyle .

Millions of people follow an unhealthy lifestyle. Hence, they encounter illness, disability and even death. Problems like metabolic diseases, joint and skeletal problems, cardio-vascular diseases, hypertension, overweight, violence and so on, can be caused by an unhealthy lifestyle. The relationship of lifestyle and health should be highly considered.

Globally, Non-communicable diseases NCDs are the leading cause of premature deaths and chronic disabilities and are responsible for almost 70% of all deaths worldwide.

Eligibility criteria: Inclusion Criteria:

Under graduate students in all grades of four randomly selected faculties include 2 practical faculties and 2 theoretical faculties during their academic year 2022/2023 who accept to participate in the study

Exclusion Criteria:

Students who refuse to participate in the study

Primary outcomes:
measure: Health Promoting Lifestyle Behaviors and associated factors among Sohag University students
timeFrame: 2 months
Secondary outcomes:
measure: Health Promoting Lifestyle Behaviors and associated factors among Sohag University students
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: supervisor
name: Rasha Abd EL-Hameed Ali, Assist professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03527940: Prognostic Markers of Patients With STEMI
Official title: Prognostic Markers of Patients With ST-segment Elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: STEMI - ST Elevation Myocardial Infarction
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 932
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with STEMI

Brief summary: To analyze the relationship between the clinical data and the outcomes of STEMI patients.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with ST-segment elevation myocardial infarction(STEMI).

Exclusion Criteria:

* Patients with concurrent infection or any documented inflammatory illness, such as arthritis or connective tissue diseases,or any other malignancy.
* Pregnant women.
* Severe hepatic dysfunction.
* Uncontrolled hypertension.

Primary outcomes:
measure: All cause mortality
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Dongying Zhang, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01030640: Study To Assess Changes In The Number Of Nerves In The Skin At The Site Where Where Tanezumab Is Injected
Official title: A Phase 1, Randomized, Double- Blind (Sponsor-Open), Placebo-Controlled Study To Examine The Density Of Intraepidermal Nerve Fibers After A Single Subcutaneous Administration Of Tanezumab In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis Pain
Chronic Low Back Pain
Pain Due to Interstitial Cystitis
Keywords: intraepidermal nerve fiber density
IENF
tanezumab
subcutaneous
healthy volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-12-11
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Subcutaneous administration of tanezumab can result in changes in the number of nerves around the injection site in the thigh.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects only
* Female subjects can not be pregnant or be nursing.
* Females and males need to use two types of birth control methods during the length of the study and one of the two methods needs to be a barrier method.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Subject can not have any chronic or acute medical condition or have had any chronic illness in the past
* Can not have any problematic skin condition.
* Females can not have more than 7 alcoholic drinks per week and males can not have more than 14 alcoholic drinks per week

Primary outcomes:
measure: To assess the change in intraepidermal nerve fiber (IENF) density in skin biopsies from proximal thigh and distal leg between baseline and postdose time points after a single SC injection of tanezumab 20 mg SC or placebo in healthy volunteers.
timeFrame: 16 weeks
measure: To compare the treatment effect between tanezumab 20 mg SC and placebo on the change in IENF density between baseline and postdose time points in skin biopsies from the proximal thigh and distal leg in healthy volunteers.
timeFrame: 16 weeks
measure: To assess the safety, tolerability and immunogenicity of a single dose of tanezumab 20 mg SC in healthy volunteers.
timeFrame: 16 weeks
Secondary outcomes:
measure: To evaluate the pharmacokinetics of a single dose of tanezumab 20 mg SC administered in the proximal thigh in healthy volunteers
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01873040: Vaccine Social Media Randomized Intervention Trial
Official title: Randomized Intervention Trial to Evaluate a Vaccine Social Media Website
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communicable Diseases
Keywords: Social Media
Vaccine
Immunization
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2013-06-07
Enrollment: 1675
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will assess the effectiveness of social media website devoted to vaccines to change immunization knowledge, perceptions and behavior. If effective, this intervention will represent an innovative, low cost and broadly applicable resource to reduce parental vaccination concerns.

The study has two hypothesis:

1. Parents receiving usual care plus social media website will demonstrate higher early childhood immunization rates to parents receiving either usual plus non interactive website or usual care only.
2. Parents receiving usual care plus social media website will demonstrate positive changes in knowledge, attitudes and beliefs supporting vaccination compared to parents receiving either usual care plus non-interactive website or usual care only.

Detailed description: Participants will be enrolled in the study, stratified based on hesitancy and randomly assigned to 1 of 3 study arms and followed for 1-2 years.

Eligibility criteria: Inclusion Criteria:

* Women \>20 weeks Pregnant (including parents of children up to 1 year of age).
* \>18 years of age

Exclusion Criteria:

* Non english speak
* Do not intend to use Kaiser insurance for the child

Primary outcomes:
measure: Days under-immunized
timeFrame: 2 years
Secondary outcomes:
measure: Knowledge, Attitudes and Beliefs about immunizations
timeFrame: Baseline, Child age 3-5 months, Child age 12-15 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: Kaiser Permanente Colorado Institute for Health Research
state: Colorado
Study officials:
affiliation: Kaiser Permanente
name: Jason M Glanz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Leary ST, Narwaney KJ, Wagner NM, Kraus CR, Omer SB, Glanz JM. Efficacy of a Web-Based Intervention to Increase Uptake of Maternal Vaccines: An RCT. Am J Prev Med. 2019 Oct;57(4):e125-e133. doi: 10.1016/j.amepre.2019.05.018. Epub 2019 Aug 27.
citation: Daley MF, Narwaney KJ, Shoup JA, Wagner NM, Glanz JM. Addressing Parents' Vaccine Concerns: A Randomized Trial of a Social Media Intervention. Am J Prev Med. 2018 Jul;55(1):44-54. doi: 10.1016/j.amepre.2018.04.010. Epub 2018 May 14.
Clinical trial NCT01165801: Size Progression of Macular Degeneration After Cataract Surgery
Official title: Size Progression of Non-Exudative Age-Related Macular Degeneration After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Age-Related Macular Degeneration
Keywords: AMD
Cataract surgery
Size of AMD
Influence of cataract surgery on AMD Size
Lead sponsor: The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
Sponsor class: OTHER
Collaborators: name: Medical Scientific Fund of the Mayor of Vienna
First posted: 2010-07-20
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to find out if in patients with non-exudative age-related macular degeneration (AMD), randomly assigned to cataract surgery, any AMD size progression or progression to exudative AMD could be detected 6 months after surgery.


Eligibility criteria: Inclusion Criteria:

* Patients with cataract and non-exudative age-related macular degeneration

Exclusion Criteria:

* Patients with retinal pathologies other than AMD, exudative AMD, progressive glaucoma, myopia \> 10 diopters, panretinal laser treatment, former cataract or vitreoretinal surgery, were excluded.

Primary outcomes:
measure: AMD size (defined central region of interest)
timeFrame: at enrollment, after 6 months
Secondary outcomes:
measure: Functional ophthalmic assessments
timeFrame: at enrollment, after 6 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: The Rudolph Foundation Hospital, Dept. of Ophthalmology
Study officials:
References:
Clinical trial NCT02363101: Health Outcomes and Costs (HOC) in Lung Cancer (LC)
Official title: Health Outcomes and Costs (HOC) in Brazilian Public Health Care System - The HOC Study in Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Lead sponsor: Instituto Nacional de Cancer, Brazil
Sponsor class: OTHER_GOV
Collaborators: name: Instituto Nacional de Cardiologia de Laranjeiras
First posted: 2015-02-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lung cancer patients from Instituto Nacional de Câncer during one year.

Brief summary: The purpose of this study is to evaluate the costs, health-related quality of life and preference values from lung cancer patients assisted in a Brazilian public health care unit.

Detailed description: The costs will be assessed by micro-costing approach. All procedures involved in lung cancer at diagnosis, staging, treatment and best supportive care will be assessed.

The health-related quality of life will be assessed by EORTC-QLQ-C30, EQ-5D and EORTC-QLQ-LC13 in all different stages of lung cancer.

An utility measure will be considered. The preference values will be assessed via discrete choice experiment. Two scenarios will be designed and the lung cancer patients will be asked about the preferences.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of lung cancer disease
* Able to understand the overall concept of study and sign the written informed consent

Exclusion Criteria:

* Illiterate
* Visible cognitive impaired
* Non-primary lung tumor

Primary outcomes:
measure: Direct costs
timeFrame: one year
measure: HRQoL
timeFrame: up to 30 days after the procedure
measure: Preference values
timeFrame: cross sectional
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: INCA - Instituto Nacional de Câncer
Study officials:
affiliation: National Cancer Institute, France
name: Carlos Gil Ferreira
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute, France
name: Luciene Schluckebier
role: STUDY_DIRECTOR
affiliation: INC
name: Marisa Santos
role: STUDY_CHAIR
affiliation: National Cancer Institute, France
name: Bruna Carvalho
role: STUDY_CHAIR
affiliation: National Cancer Institute, France
name: Pedro Masson
role: STUDY_CHAIR
affiliation: INC
name: Andréa Monteiro
role: STUDY_CHAIR
affiliation: INC
name: Bruna Medeiros
role: STUDY_CHAIR
affiliation: INC
name: Kátia Senna
role: STUDY_CHAIR
affiliation: INC
name: Márcia Gisele
role: STUDY_CHAIR
References:
Clinical trial NCT03481101: WHENII - Early Response Evaluation With FDG-PET/CT and Liquid Biopsy in Patients With NSCLC
Official title: WHENII - Early Response Evaluation With 18F-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose(FDG)- Positrons Emissions Tomography(PET)/CT and Liquid Biopsy in Patients With NSCLC (Non Small Cell Lung Cancer)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non Small Cell Lung Cancer
Circulating Tumor Cell
Circulating Tumor DNA
Keywords: early response evaluation
immunotherapy
chemotherapy
liquid biopsy
FDG-PET/CT
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: response evaluation with FDG-PET and free circulating DNA in patients with inoperable lung cancer of non small cell type during first treatment with chemotherapy or immunotherapy.
Primary purpose: DIAGNOSTIC

Brief summary: Response evaluation with FDG-PET and free circulating DNA in patients with inoperable lung cancer of non small cell type during first treatment with chemotherapy or immunotherapy.

Detailed description: Interventional study of patients with inoperable lung cancer of non small cell type undergoing 1st treatment of either chemotherapy or immunotherapy. Patients are evaluated with FDG-PET/ct and blood analyses og circulating tumor DNA and cancer markers to determine early response.

PET-CT are preceded before and after treatment is given;

* day 0 before treatment,
* day 2 after treatment and
* day 21 just before second treatment. At every FDG-PET/ct scan blood are examined for circulating tumor DNA (ctDNA) and potentially cancer markers by White genome sequencing. In total 3 PET-CT scans and 4 blood samples are performed. The result are compared with the standard CT scan after 2-3 cycles of treatment. Blood analyses are repeated after 2-3 cycles to observe any changes.

Eligibility criteria: Inclusion Criteria:

* Patients with non-small cell lung cancer (NSCLC) who is about to start treatment with chemo- or immune therapy. No prior treatment of the one given.
* Measurable decease according to RECIST criteria
* Age \> 18 years
* Performance status 0-2 (0-1 for immunotherapy)
* Understands and reads danish

Exclusion Criteria:

* Poor performance status
* Secondary active cancer
* Pregnancy
* Dysregulated diabetes mellitus

Primary outcomes:
measure: Observation of changes in metabolism in cancer cells during first treatment with chemotherapy or immunotherapy.
timeFrame: 3 months
measure: Observation of changes in circulating tumor DNA during first treatment.
timeFrame: 3 months
measure: Observation of changes in circulating tumor DNA during first treatment.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University Copenhagen
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
affiliation: Klinisk fysiologisk og Nuclearmedicinsk afd
name: Andreas Kjær
role: STUDY_DIRECTOR
References:
Clinical trial NCT03889301: ¡Yo no Estoy Loc@! Improving Treatment Engagement for Latinos Using an E-E Video
Official title: ¡Yo no Estoy Loc@! Improving Treatment Engagement for Latinos Using an E-E Video
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Depression
Lead sponsor: University of Nevada, Reno
Sponsor class: OTHER
Collaborators: name: University of Nevada, Las Vegas
First posted: 2019-03-26
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to experimental or control group.
Primary purpose: TREATMENT

Brief summary: The underutilization of behavioral health services for mood and anxiety disorders by Latinos is a public health concern warranting intervention development. Perceived stigma associated with the pursuit of behavioral health services disproportionately restricts mental healthcare in Latinos. The current study empirically tests an intervention aimed at improving perceptions of behavioral health services for mood and anxiety disorders, ultimately improving Latinos' mental health through access to treatment. The experimental intervention is based on the Entertainment-Education (E-E) model, a popular media campaign that incorporates health and educational messages in an entertaining, story-telling narrative. The E-E model incorporates characters who have characteristics, beliefs, attitudes, and behaviors that are similar to those of the targeted audience to maximize social validity. Using data gathered in focus groups with Latinos a 3-minute E-E video (in Spanish) that aims to reduce stigma towards mental illness and behavioral health services was developed. Sixty adult Latinos pursuing care at a Federally Qualified Health Center, who screen positive for anxiety and/or depression will be invited to participate in the study. Participants will be administered a structured demographic interview and measures that assess stigma and attitudes towards mental health and behavioral health services and then randomized to the E-E video or control (structured discussion about depression and anxiety) condition. Participants will then complete the study measures and be invited to attend a Cognitive Behavior Therapy (CBT) group for depression or anxiety. Consumer satisfaction will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Spanish-speaking

Exclusion Criteria:

* Screen positive for suicidality or psychosis

Primary outcomes:
measure: Change in score on Generalized Anxiety Stigma Scale (GASS)
timeFrame: immediately before and immediately after intervention
measure: Change in score on Depression Stigma Scale (DSS)
timeFrame: immediately before and immediately after intervention
measure: Change in score on Attitudes Towards Seeking Professional Help Scale (ATSPH)
timeFrame: immediately before and immediately after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Reno
country: United States
facility: Community Health Alliance
state: Nevada
Study officials:
References:
Clinical trial NCT00834301: An Open Label Trial to Evaluate the Effects of a Novel Renal Multivitamin on Inflammation and Other Biomarkers in Endstage Renal Disease Patients
Official title: An Open Label Trial to Evaluate the Effects of a Novel Renal Multivitamin on Inflammation and Other Biomarkers in Endstage Renal Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hyperphosphatemia
Inflammation
Renal Disease
Keywords: End Stage Renal Disease
Inflammation
Lead sponsor: Nephrian
Sponsor class: INDUSTRY
First posted: 2009-02-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether an ingestion of a new renal multivitamin supplement can have a beneficial effect on bone and mineral adn inflammation issues related to patients on dialysis.


Eligibility criteria: Inclusion Criteria:

* End stage renal disease patients on dialysis for at least 90 days deemed to be at low risk by the investigator for being hospitalized or have concurrent infections
* Serum phosphorous level \> 5 mg/dl
* Stable phosphate binder regimen for 2 week prior to enrollment
* Stable dose of Vitamin D for 4 weeks prior to enrollment
* Stable calcimimetic dose for 4 week prior to enrollment

Exclusion Criteria:

* patients who are pregnant
* patients who have pre existing thrombocytopenia defined as a platelet count of \<100 x 109/L
* abnormal LFTs
* baseline CRP \> 15 g/dl
* known sensitivity to any of the active ingredients
* patients who are currently enrolled in a clinical trial, or who have been in a clinical trial in the last six months
* are currently taking any immunosuppressive medications

Primary outcomes:
measure: To assess the efficacy and safety of a novel renal multivitamin on markers of bone and mineral metabolism in an ESRD population.
timeFrame: 8 weeks
Secondary outcomes:
measure: To assess the efficacy and safety of a novel renal multivitamin on markers of inflammation in an ESRD population
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Simi Valley
country: United States
facility: Simi Valley Dialysis Center
state: California
Study officials:
affiliation: Nephrian
name: Ray Chow, PhD
role: STUDY_DIRECTOR
References: