louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03963141: Retrospective Analysis to Describe Patient Profiles, Current Treatment Patterns and Economic Burden for Asthma Patients in UAE. A Descriptive Analysis of the Asthma Patient Population in the Emirate of Dubai With Respect to Healthcare Resource Utilization, Costs, and Asthma-related Treatment Pattern
Official title: Retrospective Analysis to Describe Patient Profiles, Current Treatment Patterns and Economic Burden for Asthma Patients in UAE.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2019-05-24
Enrollment: 40541
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a diagnosis of asthma during the identification period will be considered for the analysis

Brief summary: This Retrospective cohort study with an overall objective of to perform a descriptive analysis of the asthma patient population in the Emirate of Dubai with respect to healthcare resource utilization, costs, and asthma-related treatment patterns and outcome.


Eligibility criteria: Inclusion Criteria:

* Minimum two claims with asthma diagnosis, 30 days apart, during the identification period
* Minimum 12 months of baseline period
* Age ≥ 18 years on the index date
* Continuous enrolment during the baseline period and at least 180 days of follow-up period; enrolment will be defined based on at least one activity during each 90-day period from the index date

Exclusion Criteria:

• Diagnosis of COPD during the baseline period. Diagnosis of COPD will be defined as ≥1 medical claim with an ICD-10 diagnosis in any position

Primary outcomes:
measure: Asthma Patients Number
timeFrame: 1 Year
measure: Asthma-related Cost
timeFrame: 1 Year
Secondary outcomes:
measure: Asthma-related hopitalizations cost
timeFrame: 1 Year
measure: Astma-related prescription pattern
timeFrame: 1 Year
measure: Severity of Asthma per total number of patients
timeFrame: 1 Year
Other outcomes:
Locations:
city: Dubai
country: United Arab Emirates
facility: Dha Claim
Study officials:
References:
Clinical trial NCT02017041: Using mHealth to Aid Opioid Medication Adherence Pilot Study
Official title: Using mHealth to Aid Opioid Medication Adherence Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Dependence
Keywords: opioid dependence, buprenorphine, smartphone, suboxone
Lead sponsor: Care Team Solutions
Sponsor class: INDUSTRY
First posted: 2013-12-20
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: community sample

Brief summary: The purpose of this study is to evaluate the usability of an interactive smartphone application (app) designed to engage and support patients receiving bup/nal.

Detailed description: The purpose of this study is to evaluate the usability of a medication management aid for opioid dependence named SubAID. The SubAID system is a smartphone application and medication monitor designed to optimize adherence behaviors of an OD patient responsible for administering bup/nal maintenance therapy medication.

Usability of the SubAID system will be tested utilizing a 3-Stage study design over a 5 week period among a cohort of subjects prescribed bup/nal and undergoing OST.

* Stage 1 - 1 week: Participants will use only an electronic medication monitor (MedSignals) in control mode to passively record baseline adherence to medication.
* Stage 2 - 2 weeks: Participants will use MedSignals in control mode and the smartphone application.
* Stage 3 - 2 weeks: Participants will use MedSignals in active mode and the smartphone application.

After each stage usability assessments will be conducted to evaluate satisfaction with the products from participants.

Eligibility criteria: Inclusion Criteria:

* At least 21 years of age
* Physician diagnosis of opioid dependence (OD)
* Prescribed buprenorphine/naloxone (bup/nal) and acclimated to medication.
* Able to speak and read English
* Willing to provide written informed consent prior to study entry
* Able to understand the study
* Ownership of an Android or iPhone smartphone

Exclusion Criteria:

* Having any concurrent medical or psychiatric condition that, in the investigator's opinion, may preclude participation in this study; or
* Cognitive or other impairment that would interfere with completing a self-administered questionnaire.

Primary outcomes:
measure: questionnaire assessing usability of the system.
timeFrame: up to 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Care Team Solutions
state: Kentucky
Study officials:
affiliation: Care Team Solutions
name: Michael Bailey, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04793841: Population Burden of STI and Implication for Intervention in Hong Kong
Official title: Population Burden of Sexually Transmitted Infections and Implication for Intervention in Hong Kong
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: STI
Keywords: chlamydia trachomatis
Neisseria gonorrhoeae
human papillomavirus
men who have sex with men
general population
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-03-11
Enrollment: 1977
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: sexually experienced adults

Brief summary: This is a 5-year cross-disciplinary sexually transmitted infection (STI) project involving a) territory-wide and community-based studies (survey and specimen collection); b) simulation of STI transmission dynamics and comparison of STI intervention strategies through mathematical modelling and cost-effectiveness analysis. The aim of this project is to assess the burden and the transmission dynamics of STIs in the general population and men who have sex with men (MSM) in Hong Kong. Around 1300 sexually experienced adults and 900 MSM would be recruited, 100 participants would be invited for individual in-depth interviews. Main outcome measures include STI history and service preference, effectiveness as measured by the proportion of new STI infections (chlamydia, gonorrhoea and human papillomavirus infections) averted above base-case scenario, and incremental cost-effectiveness ratio.

Detailed description: After completion of baseline questionnaire, the participants are invitied for STI self-sampling. If agree, a package of self-sampling kits, instructions, and packaging materials for return post would be delivered to their selected collection points. The second round of self-sampling would be offered at least one year from the first round of self-sampled specimens collected.

Eligibility criteria: Inclusion Criteria:

* aged 18 or above
* ever having sex
* normally living in Hong Kong
* can communicate in English or Chinese

Exclusion Criteria:

* failed to provide consent

Primary outcomes:
measure: self-reported STI diagnosis in questionnaire
timeFrame: up to 2 years
measure: effectiveness of STI intervention strategies
timeFrame: 10 years
Secondary outcomes:
measure: STI symptom reported in questionnaire
timeFrame: 12 months
measure: willingness to pay for STI testing reported in questionnaire
timeFrame: 12 months
measure: prevalence of STI estimated through laboratory testing
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
state: Hong Kong, China
Study officials:
affiliation: Chinese University of Hong Kong
name: Ngai Sze Wong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04774341: Personalized Evidence-based Medicine in Patients With Atrial Fibrillation
Official title: Personalized Evidence-based Medicine Improves Outcomes of Anticoagulation Therapy in Patients With Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adherence to Personalized EBM Anticoagulant Treatment in Patients at High Risk for Stroke
Keywords: Atrial fibrillation
Personalized evidence-based medicine
Clinical decision support systems
Stroke
Anticoagulation
Guidelines
Lead sponsor: Center of Personalized Medicine, Pirogova
Sponsor class: OTHER
Collaborators: name: Center for New Medical Technologies, Novosibirsk, Russia
name: I.M. Sechenov First Moscow State Medical University
name: University of Rochester
name: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
First posted: 2021-03-01
Enrollment: 4200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at high risk for stroke with atrial fibrillation

Brief summary: A retrospective analysis

Detailed description: 4200 EMR of patients at high risk for stroke with 1-year follow-up will be enrolled in the current study and analyzed by clinical decision support systems (CDSS MedicBK) utilizing a core laboratory.

Eligibility criteria: Inclusion Criteria:

EMR only if an ECG diagnosis (12-lead ECG, 24-h Holter, or other electrocardiographic documentation) confirming AF was made in patients at high risk for stroke by CHA2DS2-VASc (≥2 in men and ≥3 in women).

Exclusion Criteria:

No

Primary outcomes:
measure: The percentage of guideline-based and personalized EBM recommendations
timeFrame: 1-year
Secondary outcomes:
measure: Quantify the performance of the CDSS (MedicBK) algorithm
timeFrame: 1-year
measure: 1-year FU outcomes
timeFrame: 1-year
measure: Predictors
timeFrame: 1-year
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Evgeny Pokushalov
Study officials:
affiliation: Center for New Medical Technologies, Novosibirsk, Russia
name: Evgeny Pokushalov, Prof. MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03635541: Dynamic Changes and Risk Factors of Fibrosis and Steatosis Progression in Nonalcoholic Fatty Liver Disease
Official title: Dynamic Changes and Risk Factors of Fibrosis and Steatosis Progression in Nonalcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: non alcoholic fatty liver disease
non alcoholic steatohepatitis
steatosis
fibrosis
progression
risk factors
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Non alcoholic fatty liver disease patients diagnosed with liver biopsy.

Brief summary: It is an observational study of non alcoholic fatty liver disease (NAFLD) patients with a calculated sample size of 90. Liver biopsy proved NAFLD patients will be recruited in this study for 2 years follow-up. Patients will be assessed at baseline, at every six months for blood count, liver function test, fasting blood-glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness.

Detailed description: No.

Eligibility criteria: Inclusion Criteria:

* 1. 18-70 years of age, 2. liver biopsy proven non alcoholic fatty liver disease. 3. Agree to be followed up regularly; 4. Signature of written informed consent.

Exclusion Criteria:

* 1. Patients with other liver diseases including viral hepatitis, alcoholic liver diseases, autoimmune liver diseases, drug induced liver diseases, genetic metabolic liver disease.

  2. Patients undergone bariatric surgery. 3. HIV infected patients. 4. Pregnant women. 5. Patients with severe diseases with expected survival less than 2 years. 6. Patients had followings before liver biopsy:
  1. Hepatocellular carcinoma or suspected liver cancer,
  2. Decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma;
  3. Other malignancy,
  4. Undergone liver transplantation surgery. 7.Patients with any other reasons not suitable for the study.

Primary outcomes:
measure: fibrosis progrssion
timeFrame: 2 years
measure: steatosis progression
timeFrame: 2 years
Secondary outcomes:
measure: liver related events
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Hong You, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04333641: Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography
Official title: Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm (AAA)
Keywords: abdominal Aortic Aneurysm
CT
risk factor
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 323
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with small abdominal aortic aneurysm with maximal aneurysm of 30 \~50 mm

Brief summary: Study purpose: This study will investigate anatomical factors associated with increased risk of major adverse aorta-related event and accelerated growth of abdominal aneurysm based on 3-dimensional analysis of CT images.

Study design: a multicenter single-arm prospective observational study.

Subject: patients with small abdominal aortic aneurysm with maximal diameter of 30-50 mm (n=323)

Methods: Patients diagnosed with small AAA based on CT will be enrolled after considering inclusion and exclusion criteria and prospectively followed clinically and with CT at 1 year.

Primary endpoint: Major adverse aorta-related events (death, aortic rupture, or aneurysm growth \>0.4 cm per year) at 1 year

Secondary endpoints: 1) clinical events : death, aortic rupture, aneurysm growth \>0.4 cm per year, surgical or endovascular repair 2) Changes in CT parameters of aneurysm: diameter, volume, wall shear stress

Detailed description: Prospective single-arm multicenter registry

Eligibility criteria: Inclusion Criteria:

- abdominal aortic aneurysm with maximum diameter of 30-50 mm

Exclusion Criteria:

* Age \<19 years
* Serum Cr\> 1.5mg/dL or eGFR\<30 mL/min
* Known allergic reactions to iodine contrast media
* Women in pregnancy or women of childbearing age
* Abdominal aortic aneurysms indicated for endovascular or surgical repair (symptomatic aneurysm or aneurysms with diameter \>5cm)
* Saccular type aneurysm, infected or inflammatory aneurysm
* Combined aortic dissection
* Aneurysms associated with genetic or connective tissue diseases (Marfan syndrome, Shprintzen-Goldberg syndrome, Loeys-Dietz syndrome, Takayasu's arteritis, Behcet's disease)
* Past history of surgical or endovascular repair of aorta
* Any surgical or endovascular repair planned within 1 year
* Life expectancy \< 1 year

Primary outcomes:
measure: Major adverse aorta-related events
timeFrame: 1 year
Secondary outcomes:
measure: Number of clinical events
timeFrame: 1 year
measure: Change in CT parameter of aneurysm
timeFrame: 1 year
measure: Change in CT parameter of aneurysm
timeFrame: 1 year
measure: Change in CT parameter of aneurysm
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Severance Cardiovascular Hospital
Study officials:
References:
Clinical trial NCT05376241: Promoting Informed Choice for Breast Cancer Screening
Official title: Understanding Affective Processing of Scientific Evidence to Promote Informed Choice for Breast Cancer Screening
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Breast Cancer Screening
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-05-17
Enrollment: 498
Sex: FEMALE
Minimum age (years): 39
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women age 39-49 in the United States.

Brief summary: Identify the prevalence and predictors of reactance, self-exemption, disbelief, source derogation in reaction to evidence about mammography benefits and harms, and consequences for decision-making and trust.

Detailed description: In this study, the goal is to identify the prevalence and predictors of reactance, self-exemption, disbelief, and source derogation in reaction to evidence about mammography benefits and harms, and consequences for decision-making and trust. Research has not yet systematically identified the proportion of women who respond negatively (vs. positively) to evidence about the benefits and harms of mammography screening, or attempted to explain these responses by examining theory-driven predictors. The Investigator will develop and conduct a probability-based nationally representative survey in which mammography evidence is communicated using current best practices in risk communication. The Investigators will identify theory-driven predictors of negative and positive responses to that evidence, and identify consequences of these responses for screening decision-making and trust.

Eligibility criteria: Inclusion Criteria:

* Female
* Between 39-49 years of age
* No history of breast cancer
* No known BRCA 1/2 mutation

Exclusion Criteria:

* Non-English or Spanish Speaking
* Persons unable to provide informed consent (e.g. sever dementia or cognitive disability or illiterate
* History of breast cancer
* Known BRCA 1/2 mutation

Primary outcomes:
measure: Reactance
timeFrame: 24 hours
measure: Disbelief
timeFrame: 24 hours
measure: Source derogation
timeFrame: 24 hours
measure: Self exemption
timeFrame: 24 hours
measure: Screening Intentions
timeFrame: 24 hours
Secondary outcomes:
measure: Medical mistrust scale (Eaton et al., 2015)
timeFrame: 24 hours
measure: Mammography screening knowledge (adapted from Hersch et al., 2015)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Laura Scherer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05598541: Finnish Patient-Reported Outcomes Initiative for Shoulder and Elbow
Official title: Finnish Patient-Reported Outcomes Initiative for Shoulder and Elbow
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cultural Adaptation of Shoulder and Elbow PROMs
Definition of the Patients Acceptable Symptomatic State
Definition of the Minimal Important Difference
Keywords: shoulder
elbow
patient reported outcomes
validation
transcultural adaptation
patients acceptable symptomatic state (PASS)
minimal important difference (MID)
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2022-10-28
Enrollment: 600
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: Secondary care outpatient clinic

Brief summary: The purpose of φ-PROMISE project is to carry out a cultural adaptation (translate into Finnish and validate) some of the most frequently used shoulder- and elbow-specific patient-reported outcome measures, PROMs. In addition, we aim to investigate which outcome measures are the most relevant for assessing the severity of complaints and treatment outcomes. Also, we will define the Patients Acceptable Symptomatic State (PASS) and the Minimal Important Difference (MID) of the individual outcome measures.


Eligibility criteria: Inclusion Criteria:

* Orthopedic outpatient visit at the Helsinki University Hospital
* Signed informed consent
* Age over 18 years
* Finnish as language of communication

Exclusion Criteria:

* Recent surgery (within 2 months)
* Insufficient compliance

Primary outcomes:
measure: Validation
timeFrame: 2 weeks
Secondary outcomes:
measure: PASS
timeFrame: 1 year
measure: MID
timeFrame: 1 year
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
References:
Clinical trial NCT00207441: Comparing ASHC and CDSMP Outcomes In Arthritis
Official title: Comparing ASHC and CDSMP Outcomes In Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis
Keywords: arthritis
chronic disease
self management
self efficacy
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: University of North Carolina, Chapel Hill
name: East Carolina University
First posted: 2005-09-21
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The arthritis-specific Arthritis Self Help Course (ASHC) and the more generic Chronic Disease Self Management Program (CDSMP) teach generalizable skills for managing arthritis and other chronic diseases. In some locations it may be more feasible to combine efforts and offer the generic course rather than the arthritis-specific program. However anecdotal evidence has questioned whether people with arthritis obtain as much benefit from the more generic course as they do the arthritis-specific course. The primary purpose of this research studies is to compare health outcomes among people with arthritis who participate in either ASHC or the CDSMP. The North Carolina project is focusing primarily on African Americans from 6 rural counties in North Carolina. The results of this research will be used to guide Arthritis program recommendations on the use of ASHC and CDSMP to improve the quality of life for people with arthritis.


Eligibility criteria: Inclusion Criteria:

African american adults with arthritis Caucasian adults with arthritis

Exclusion Criteria:

-

Primary outcomes:
measure: Health related quality of life, measured at 4 and 12 months,
timeFrame: 4 months, 12 months
measure: Health care utilization measured at 4 and 12 months
timeFrame: 4 months, 12 months
Secondary outcomes:
measure: Self management behaviors measured at 4 and 12 months
timeFrame: 4 months, 12 months
measure: Self efficacy for arthritis management, measured at 4 and 12 months
timeFrame: 4 months, 12 months
Other outcomes:
Locations:
city: New Bern
country: United States
facility: Craven County Health Department
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jean Goeppinger, PhD RN
role: PRINCIPAL_INVESTIGATOR
References: