louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00470886: Assessment of Compliance With Antihypertensive Telmisartan Therapy
Official title: A Non-Interventional, Post-Marketing Surveillance, Phase IV Study to Assess Compliance With Antihypertensive Telmisartan Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Bang & Olufsen Medicom
First posted: 2007-05-08
Enrollment: 3400
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: Primary care clinic hypertensive patients for whom physician decided to start the treatment with telmisartan

Brief summary: The purpose of this study is to asses the efficacy and safety of Telmisartan depending on the use of an electronic therapy monitoring device (HelpingHand) in a real life setting and to asses patients compliance to the therapy with Telmisartan in relation to use of electronic therapy monitoring device.


Eligibility criteria: Inclusion Criteria:

* Age over 18
* Untreated or ineffectively treated arterial hypertension

Exclusion Criteria:

* Cholestatic disorders and severe hepatic failure
* Allergy to Telmisartan
* Pregnancy and lactation period
* Unwillingness to participate in the study
* Inability to use the drug reminder device
* Unwillingness to use the drug reminder device

Primary outcomes:
measure: Efficacy and safety of the treatment with telmisartan reported by the physician with regard to usage the HelpingHand device
timeFrame: At all four planned control visits. (Approx. interval between visits 3 months)
Secondary outcomes:
measure: Compliance with the treatment calculated on the basis of by HelpingHand and patients questionnaires
timeFrame: At all four planned control visits. (Approx. interval between visits 3 months)
Other outcomes:
Locations:
city: Many Locations
country: Poland
city: Many Locations
country: Slovakia
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06484686: An Immunity Persistence Study of Booster Dose of Live Attenuated Varicella Vaccine
Official title: An Open-label Clinical Trial to Evaluate the Immunity Persistence of Live Attenuated Varicella Vaccine At 6 and 10 Years After Booster Dose Immunization with Live Attenuated Varicella Vaccine
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Varicella
Lead sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-03
Enrollment: 414
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This an open-label phase Ⅳ clinical trial of live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.The purpose of this study is to evaluate the immunity persistence of live attenuated varicella vaccine at 6 and 10 years after booster dose.

Detailed description: A total of 792 subjects aged 2 to 6 years including in per-protocol set (PPS) of immunogenicity assessment from previous phase Ⅲ clinical trial were enrolled. About 3.0ml of venous blood was collected at 6 and 10 years after booster immunization for antibody detection.

Eligibility criteria: Inclusion Criteria:

* Subjects in PPS of previous phase Ⅲ clinical trial of varicella vaccine;
* The subjects and/or guardian can understand and voluntarily sign the informed consent form;
* Proven legal identity.

Exclusion Criteria:

* Beyond the blood collection window period;
* History of varicella or shingles;
* History of varicella vaccination since phase Ⅲ clinical trial;
* According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Primary outcomes:
measure: Seropositive rate
timeFrame: at 6 years after booster vaccination
measure: Seropositive rate
timeFrame: at 10 years after booster vaccination
measure: GMT of VZV antibody
timeFrame: at 6 years after booster vaccination
measure: GMT of VZV antibody
timeFrame: at 10 years after booster vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial Center for Disease Control and Prevention
state: Henan
Study officials:
affiliation: Henan Provincial Center for Disease Control and Prevention
name: Lili Huang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01103986: Assessing the Effectiveness of a Health Literacy Intervention in the Workplace
Official title: Assessing the Effectiveness of a Health Literacy Intervention in the Workplace: A Quasi-experimental Pre-post Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Literacy
Keywords: health literacy
consumer health information
patient education as topics/methods
patient participation
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2010-04-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the effectiveness of a health literacy/motivational intervention in a workplace setting. Parents will be taught how to use a child health book to lessen inappropriate use of physician services and improve parent confidence in their ability to identify and obtain necessary assistance when their children are ill.


Eligibility criteria: Inclusion Criteria:

* currently employed at the Children's Mercy Hospitals and Clinics, MO or KS, or working under contract
* parent/legally authorized representative/primary care giver taking care of a child birth to 12 years old

Exclusion Criteria:

* non-English speaking and reading
* under 18 years old unless a minor parent
* a medical or nursing degree (MD, DO, Physician's Assistant, Nurse Practitioner, RN or LPN)

Primary outcomes:
measure: number of non emergency room clinician visits
timeFrame: within 1 week prior to class and 90 days post-class
Secondary outcomes:
measure: number of emergency department visits
timeFrame: within 1 week prior to class and 90 days post-class
measure: pre and post intervention measures of self-identified competency.
timeFrame: within 1 week prior to class and 90 days post-class
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The Children's Mercy Hospitals and Clinics
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Nancy A Neilan, MT (ASCP)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bryan C. Provider and policy response to reverse the consequences of low health literacy. J Healthc Manag. 2008 Jul-Aug;53(4):230-41.
citation: Ensuring Positive Health Outcomes in Head Start Children and Famiies Pilot Study, Executive Summary. Herman A, September 2002
Clinical trial NCT02483286: Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area
Official title: Osteoporosis and Fall Prevention With Multiple Interventions in the Metropolitan Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis Fracture
Keywords: Osteoporosis
Fall
Fracture
sarcopenia
Exercise
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: The Taiwanese Osteoporosis Association.
name: Wang Jhan-Yang Charitable Trust Fund
First posted: 2015-06-26
Enrollment: 139
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: OBJECTIVES To determine the effects of 3 exercise interventions on sarcopenic indices among community-dwelling older adults with high osteoporotic fracture risks.

MATERIAL AND METHOD The current study enrolled subjects who screened high risk of fall, osteoporosis/fracture by standardized questionnaires or FRAX. Subjects at the National Taiwan University Hospital Bei-Hu Branch (NTUHBB) were randomized into integrated care group (ICG, target n=50) and muscle training group (MTG, target n=50). Subjects from Lingko Chang Gung Memorial Hospital (LCGMH) were all assigned into X-box group (XBG, target n=30). All participants received a CD-ROM and a one education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, and coping strategy and another hour of professional led exercise program. ICG subjects received once weekly group exercise while MTG subjects received twice weekly machine-based resistence training on major muscle groups. XBG subjects rececived twice weekly exercise with X-box based programs. Major outcomes were muscle mass (measured by bio-impedance analysis), grip strength, walking speed, and lower leg extension power at baseline and after 12-weeks of intervention.


Eligibility criteria: Inclusion Criteria:

1. older than 50 years of age
2. high risk as defined from one of the following criteria:

   * score\>=1 on one minute osteoporosis risk questionnaire
   * 10 year predicted fracture risk \>=20% for major osteoporotic fracture or \>=3% for hip fracture from FRAX
   * fall\>=2 times in pass 1 year
3. having a bone mineral density test within one year period
4. having the capability to understand the study and complete the study interventions
5. willing to participate for the intervention and study follow ups

Exclusion Criteria:

1. People younger than 50 years of age
2. Could not communicate because of hearing, visual, or cognitive problems
3. Unable to stand and walk unaided (walking aids are acceptable)

Primary outcomes:
measure: Lower extremity extensor power
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ding-Cheng Chan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03746886: Lipids and Other Bioactive Compounds of Human Breast Milk
Official title: Lipids and Other Bioactive Compounds of Human Breast Milk and Infant Formulas.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Milk Collection
Keywords: breast milk
lipids
bioactive compounds
infant formula
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18-45 years old women who breast-feed their 0-6 months old child

Brief summary: The biochemical differences in the composition of breast milk and formula have not been profoundly established in all compound groups. Increased understanding of breast milk composition, the normal variation of various bioactive compounds and their levels is required to be able to develop formulas better corresponding the breast milk, and ensure the optimal development of also the formula-fed babies.


Eligibility criteria: Inclusion Criteria:

* breast-fed child was born full-time and is healthy.
* age of the breast-fed child is 0-6 months

Exclusion Criteria:

* breast-fed child was born prematurely (gestation week \<37)

Primary outcomes:
measure: Relative proportions (%) of regioisomers within selected molecular species (acyl carbon number:number of double bonds 50:1 and 52:2) in triacylglycerols.
timeFrame: 11/2018-12/2019
measure: Relative proportions (%) of fatty acids in triacylglycerols of human milk.
timeFrame: 11/2018-12/2019
measure: Quantity (mg/ml) of lipid soluble compounds in triacylglycerols of human milk.
timeFrame: 11/2018-12/2019
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Department of Biochemistry, University of Turku
Study officials:
affiliation: University of Turku
name: Kaisa M Linderborg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04816786: COVID-19 Patients Admitted to the ICU
Official title: Prognostic Factors and Predictors of Mortality in COVID-19 Patients Admitted to the ICU. An Aid for Triage, Counseling, and Resource Allocation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Ministry of Health, Kuwait
Sponsor class: OTHER_GOV
First posted: 2021-03-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the hospital and suspected of having the COVID-19 virus. Patients who are positive on a PCR test are usually traiged to be managed on the wards Vs ICU (Intensive care unit). This is based on a number of parameters; including but not limited to The severity of the symptoms, vital signs, lab results, co-morbidities, age.

Brief summary: A retrospective analysis of the adult COVID-19 patients admitted to the ICU. A chart review will be conducted and multiple baseline characteristics, demographics, and treatments given will be recorded.

Variables collected will include Age, Gender, BMI, Smoking status, Past medical history, Vital signs on admission, symptoms on admission, duration of symptoms, laboratory results on admission, treatment given. Treatment options will include (Steroids, plasma exchange, IVIG, antibiotics, mode of respiratory support).

Primary outcomes will include; Death, duration of ICU stay, duration of mechanical ventilation, in-hospital complications.

A regression model will be used to predict poor prognostic factors. Inclusion criteria: patients with confirmed PCR results for COVID-19 AND require ICU admission. Exclusion criteria: those with negative results, pediatric patients and those not requiring ICU admission.


Eligibility criteria: Inclusion Criteria:

* Adults
* Positive PCR test for COVID-19
* Require admission to ICU

Exclusion Criteria:

* Pediatric patients\\
* Any patient not requiring admission to ICU

Primary outcomes:
measure: Death
timeFrame: 30 day mortality
measure: Duration of ICU stay
timeFrame: 30 days
measure: Duration of mechanical ventilation
timeFrame: 30 days
Secondary outcomes:
measure: In-Hospital complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Mubarak al Kabeer hospital
state: Outside U.S./Canada
Study officials:
References:
Clinical trial NCT06240286: Comparing Manual and Neurocognitive Skills-While Sitting, Standing, Walking on a Treadmill and Using a Stepper.
Official title: Comparing Manual and Neurocognitive Skills-While Sitting, Standing, Walking on a Treadmill and Using a Stepper.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Neurocognitive function
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study is being performed to evaluate the effect of different active workstations (e.g., standing, stepping, or walking stations) on work performance through the evaluation of neurocognitive function using reasoning, memory, concentration, and fine motor skills evaluation tools.


Eligibility criteria: Inclusion Criteria:

* Dan Abraham Healthy Living Center (DAHLC) members and non-members that have provided informed consent to participate in this study.

Exclusion Criteria:

* Unable to stand up, walk on a treadmill or use a stepper.
* Alzheimer, dementia or any memory impairment.
* Cannot attempt fine motor skills.
* Not willing to use a treadmill, stepper or standing desk.
* Not a present user of an active office.

Primary outcomes:
measure: Double Trouble Task Score
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: Grammatical Reasoning Test Score
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: Odd One Out Test Score
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: Object Reasoning Task Score
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: Spatial Span Task Score
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: Monkey Ladder Task Score
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: Digit Span Task Score
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: Paired Associates Task Score
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: Rotations Task Score
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: Feature Match Task Score
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: Polygons Task Score
timeFrame: Day 1, Day 2, Day 3, Day 4
measure: Typing Test Score
timeFrame: Day 1, Day 2, Day 3, Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Francisco Lopez-Jimenez, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06043986: Would Artificial Intelligence Reduce Delays to Nurse Response Times
Official title: Would Artifical Intelligence Reduce Delays to Nurse Response Times
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nurse's Role
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to the cardiology ward

Brief summary: Patients are admitted to wards at all times of day and night and in various states of ill health. As this research is non interventional and does not impact on patient safety, the guidance from the ethics committee was reviewed and agreed that it would be appropriate to enrol every admission into the 2 bed bays and gain consent within 24 hours of admission.All data collected within the trial using the smart tablets will be associated to a study number, no patient details will be stored on the smart tablet and therefore the cloud data store.It has been discussed with the trust information governance and this complies with their regulations.

Any patient identifiable data will be kept by the research team. All data will be archived and stored as per the Sponsors policy. The novel nurse call system has been designed to be user friendly to all patients regardless of age, learning ability and first language used. By using colours, images and words in the hope that this will be accessible to all. The nursing staff on the ward advised on the main reasons for the nurse call system activation and therefore the icons used in the novel system were adapted from this. This trial was discussed in the patient and public involvement group. As this is a pilot trial, any adaptions that need to be made will be made before the large scale trial.


Eligibility criteria: Inclusion Criteria:

All adults 18 years who are admitted to the cardiology admissions ward will be eligible to take part.

-

Exclusion Criteria: Any patient who does not wish to participate will have their anonymised data removed from the trial.

-

Primary outcomes:
measure: study objective
timeFrame: 1 year
Secondary outcomes:
measure: Nursing time saved
timeFrame: 1 year
measure: patient acceptability of the novel system
timeFrame: 1 year
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospital NHS Trust
Study officials:
References:
Clinical trial NCT00981786: 24-Hour Intraocular Pressure With Brinzolamide/Timolol Versus Brimonidine/Timolol
Official title: Quality of 24-hour Intraocular Pressure Control Obtained With the Brinzolamide/Timolol Fixed Combination Compared With the Brimonidine/Timolol Fixed Combination When Added to Travoprost Monotherapy in Subjects With Open-angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: 24-hour IOP control
brinzolamide/timolol
brimonidine/timolol
travoprost
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2009-09-22
Enrollment: 51
Sex: ALL
Minimum age (years): 29
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The proposed crossover study will compare for the first time the quality of 24-hour intraocular pressure control with the combination of travoprost and brinzolamide/timolol compared with travoprost and brimonidine/timolol in glaucoma patients insufficiently controlled with travoprost. This comparison may determine the real efficacy of the two fixed combinations when added to the prostaglandin. The design of the proposed study should facilitate a better understanding of the role of these medications in glaucoma management.


Eligibility criteria: Inclusion Criteria:

* Patient has open-angle glaucoma and is older than 29 years
* Patients should exhibit typical disc, or field changes and an untreated morning IOP greater than 25 mm Hg
* Patients are treated for at least 3 months with travoprost and should have demonstrated at least a 20% morning IOP reduction
* Patient deemed by PI to require adjunctive therapy to obtain desired target IOP
* Patient should exhibit IOP greater than 18 mm Hg on travoprost monotherapy (2 separate IOP readings at 10:00)
* Patient has mild to moderate glaucoma (field loss more than 16 dB; cupping 0.8 or less)
* Distance best corrected Snellen visual acuity at least 0.1
* No contraindications to travoprost, brimonidine, brinzolamide and β-blockers
* No history of lack of response (\<10% morning IOP reduction) to any medication
* Patient can understand the instructions and adhere to medications

Exclusion Criteria:

* Female patient of childbearing potential or lactating mother
* History of trauma, inflammation, surgery
* History of past use of steroids (within 2 months), severe dry eyes and use of contact lenses
* Signs of ocular infection, except blepharitis
* Evidence of corneal abnormality that may affect IOP measurements etc
* Closed angle
* History of non-compliance

Primary outcomes:
measure: Mean 24-hour intraocular pressure
timeFrame: 3 months
Secondary outcomes:
measure: Fluctuation of 24-hour intraocular pressure
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Glaucoma Unit, 1st University Department of Ophthalmology
name: Anastasios G Konstas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: