louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05721534: Deprescribing and Health-related Effects
Official title: Effective Deprescribing in Primary Care Without Deterioration of Health-related Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Disease
Keywords: Primary care
Medication review
Deprescribing
Polypharmacy
Chronic disease management
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Frederikshavn Kommune, Frederikshavn, Denmark
name: Lægeklinikken Frederikshavn, Frederikshavn, Denmark
First posted: 2023-02-10
Enrollment: 87
Sex: ALL
Minimum age (years): 50
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study included care home residents living in selected care homes, in which the GPF was associated "care home doctors", and community-dwelling patients with chronic disease listed with the GPF.

Brief summary: In a primary care settled quality improvement project aiming to deprescribe medication through a medication review intervention, we investigated how the implemented medication changes affected health-related outcomes in real-life patients.

Detailed description: The project was approved by the Management in the Municipality of Frederikshavn. According to Danish legislation, no formal permission from the national or regional Committee on Health Research Ethics was required for this type of study, as patients were not treated inferior to usual care and no biological material was collected. It was conducted as a quality improvement project and informed consent was not required for the specific data collected. The study is in compliance with the General Data Protection Regulation and a part of North Denmark Region's record of processing activities (K2023-008).

Eligibility criteria: Inclusion Criteria:

* new residents and residents that had not yet attended a consultation focusing on pharmacological treatment in The Chronic Care Model.
* patients were invited for the consultation focusing on pharmacological treatment in the month of their birthday and, thereby, included randomly and consecutively throughout the study period.

Exclusion Criteria:

* unable to collaborate on follow-up questionnaires

Primary outcomes:
measure: self-reported health status
timeFrame: 4 months
Secondary outcomes:
measure: general condition
timeFrame: 4 months
measure: functional level
timeFrame: 4 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
affiliation: Professor
name: Anne E Olesen
role: STUDY_CHAIR
References:
Clinical trial NCT00594334: Effect of Actonel on Periodontal Health of Postmenopausal Women
Official title: Effect of Actonel on Periodontal Health of Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Periodontal Disease
Keywords: osteopenia
periodontitis
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2008-01-15
Enrollment: 0
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypothesis: Women who use Actonel (risedronate) for osteopenia will show beneficial periodontal effects.

Detailed description: Women who use Actonel for osteopenia will show beneficial attachment loss, alveolar bone height and morphology as compared to those who do not when oral hygiene is corrected for.

Eligibility criteria: Inclusion Criteria:

* Osteopenia
* Postmenopausal

Exclusion Criteria:

* Male
* Diabetes

Primary outcomes:
measure: Periodontal alveolar bone changes
timeFrame: one year
Secondary outcomes:
measure: Periodontal attachment levels
timeFrame: one year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Uhcmc
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: james liu, md
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals Cleveland Medical Center
name: leena palomo, dds msd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00754234: Iron Bioavailability From MyPyramid Menus
Official title: Iron Bioavailability From MyPyramid Menus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonheme Iron Absorption
Keywords: iron absorption
iron requirements
dietary guidelines
MyPyramid
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2008-09-17
Enrollment: 16
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will measure nonheme iron absorption from each of the 7 daily MyPyramid menus. Such measurements will confirm whether modifications are needed to meet dietary iron recommendations and will provide data useful for validation algorithms to calculate dietary iron bioavailability.

Detailed description: Nonheme iron absorption is measured with 59Fe tracer added to a 1-day menu, with iron retention detected two weeks later in a whole body scintillation counter. Each subject has iron absorption measured from each of 7 1-d menus formulated to meet the US dietary guidelines (MyPyramid menus), with the order of menus randomly assigned. Each subject participates for 14 wk to test all 7 menus.

Eligibility criteria: Inclusion Criteria:

* Women 21 to 50 years old

Exclusion Criteria:

* Anemia,
* High blood pressure,
* Disorders affecting iron absorption or retention,
* Underlying medical conditions,
* Taking medication other than birth control pills or hormone replacement therapy,
* Pregnancy,
* Daily use of analgesics

Primary outcomes:
measure: Nonheme Iron Absorption
timeFrame: 2 weeks (wks)
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Janet R Hunt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04577534: COVID-19: Salvage TOcilizumab as a Rescue Measure
Official title: COVID-19: Salvage TOcilizumab as a Rescue Measure. Use of Tocilizumab in the Inflammatory Phase of COVID-19 / New Coronavirus Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
Keywords: COVID-19
new coronavirus disease
tocilizumab
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2020-10-08
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluating the efficacy of Tocilizumab in hospitalized patients in the inflammatory phase of COVID-19. Randomization 2:1 (TCZ:standard of care).


Eligibility criteria: Inclusion Criteria:

* written informed consaent obtained
* hospitalized with COVID-19 disease
* Age \>/= 18 years
* SARS CoV-2 NhO posit
* Sp=2 \</93% on ambient air or respiratory rate \>30 /min
* Any 2 of the 4: P-IL-6 \> 2 x ULN / P-ferritin \> 2 x ULN / P-FIDD \>1.5 mg/l / P- CRP \>40 mg/l without obvious presence of bacterial infection (normal values: P -IL-6 \<5.9 ng/l; P-ferritin, men 30-400 mikrog/l, women 13-150 mikrog/l ; P-FIDD (Fibrin degradation products, D-dimer) \<0.5 mg/l; P-CRP \<10 mg/l)

Exclusion Criteria:

* Known severe allergic reactions to monoclonal antibodies
* Active confirmed tuberculosis with ongoing treatment or obvious tuberculosis or obvious other bacterial, fungal or viral infection (besides COVID-19)
* In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
* Long-term oral anti-rejection or immunomodulatory drugs (including corticosteroids equivalent to methylprednison 15mg/day)
* Pregnant or lactating women. If needed, exclusion of pregnancy should be performed by laboratory test (U-hCG-O).
* Participating in other drug clinical trials
* Absolute neutrophil count \< 1 x10E9/l
* Platelet count \<50 x10E9/l
* ALAT \>10x ULN

Primary outcomes:
measure: Clinical status at day 28
timeFrame: day 28
Secondary outcomes:
measure: Time to clinical improvement
timeFrame: 28 days
measure: Time to decline of at least 2 categories
timeFrame: 28 days
measure: Incidence of mechanical and/or non-invasive ventilation
timeFrame: 28 days
measure: Number of ventilator-free days to day 28
timeFrame: 28 days
measure: Organ failure free days to day 28
timeFrame: 28 days
measure: Incidence of ICU stay
timeFrame: 28 days
measure: Duration of ICU stay
timeFrame: 28 days
measure: Time to clinical failure
timeFrame: 28 days
measure: SAPS II
timeFrame: 28 days
measure: CCI
timeFrame: 28 days
measure: APACHE II
timeFrame: 28 days
measure: SOFA 6
timeFrame: 28 days
measure: Mortality rate
timeFrame: 28 days
measure: Time to hospital discharge or "ready for discharge"
timeFrame: 28 days
measure: Duration of supplemental oxygen
timeFrame: 28 days
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
References:
Clinical trial NCT01607034: Study in Healthy Volunteers of the Bioavailability of Dexpramipexole Tablets and Food Effects
Official title: An Open-Label, Randomized, Crossover Study to Assess the Bioavailability of Dexpramipexole Administered in Soft Food and Water, and in Intact Tablet Form in the Fasted and Fed States in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Knopp Biosciences
Sponsor class: INDUSTRY
First posted: 2012-05-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To assess the bioavailability of dexpramipexole when mixed in soft food and water, and in intact tablet form in the fasted and fed states in healthy volunteers.

Detailed description: The effect of food on dexpramipexole bioavailability following administration of the proposed commercial formulation (capsule-shaped tablet) at the anticipated therapeutic dose (150 mg twice daily) has not been studied. Therefore, this study has been designed to evaluate the effect of a standard high-fat, high-calorie meal on dexpramipexole bioavailability following administration of a single 150 mg dose in healthy volunteers, consistent with US Food and Drug Administration (FDA) and European Medicines Agency (EMA) recommendations.

Additionally, patients with ALS can have difficulty swallowing tablets, necessitating alternative methods of administration for the drug. Therefore, this study has also been designed to evaluate the bioavailability of dexpramipexole mixed with water or crushed in soft food (applesauce).

Eligibility criteria: Inclusion Criteria:

* Subjects who, in the opinion of the Investigator, are healthy as determined by pre-study medical history, physical examination and 12-lead ECG.
* Adult males/females aged 18 to 55 years inclusive.
* Male subjects and female subjects of childbearing potential must practice effective contraception during the study and 90 days after their last dose of study drug.

Exclusion Criteria:

* History of malignant disease, including solid tumors and hematologic malignancies.
* History of any clinically significant endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases, as determined by the Investigator.
* Surgery within 90 days prior to check in.

Primary outcomes:
measure: PK parameters of dexpramipexole including maximum plasma concentration (Cmax) and the area under the plasma concentration-time curve over time from 0 to infinity (AUC0-inf) of dexpramipexole.
timeFrame: zero to 48 hours post-dose
Secondary outcomes:
measure: Time to the maximum plasma concentration (Tmax), the area under the plasma concentration-time curve over time from 0 to t (AUC0-t) and terminal half-life (t½) of dexpramipexole.
timeFrame: zero to 48 hours post-dose
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: Research Site
state: Minnesota
Study officials:
References:
Clinical trial NCT02877017: Family Activation and Communication About Errors and Safety (FACES)
Official title: Family Activation and Communication About Errors and Safety (FACES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Family Reported Errors and Adverse Events
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 985
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pre-post intervention study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Miscommunications are a leading cause of serious medical errors in hospitals, contributing to more than 60% of sentinel events, the most serious adverse events reported to the Joint Commission. Efforts to improve patient safety in hospitals have centered on improving communication between providers. While provider-focused communication interventions have led to reductions in patient harm, patients and families have been notably absent from most interventions to improve patient safety. This proposal seeks to develop a family safety reporting intervention.


Eligibility criteria: Inclusion Criteria:

* Primary caregiver of a child hospitalized on the study units during the study period or hospital employee who works on the study unit(s)
* Country of Origin: United States
* Primarily English- or Spanish-speaking

Exclusion Criteria:

* International patients

Primary outcomes:
measure: Family Safety Reporting Rates
timeFrame: During both baseline and intervention periods, the time frame for each participant being assessed was from admission to discharge, on average approximately 5-14 days.
Secondary outcomes:
measure: Family Reported Hospital Safety Climate Scores
timeFrame: During both baseline and intervention periods, the time frame for each participant being assessed was from admission to discharge, on average approximately 5-14 days.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital/Harvard Medical School
name: Alisa Khan, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01207817: Effect of Ambient Light on the Parameters of the Pupillary Light Reflex
Official title: Effect of Ambient Light on the Parameters of the Pupillary Light Reflex
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Keywords: a light flash in each eye for a total of 48 measurements
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2010-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volinteers

Brief summary: The purpose of this study is to determine the effects of varying luminescent levels on the pupillary response.

Detailed description: Evaluation of the pupillary response is an underemphasized aspect of the assessment of visual function. The pupillary light reflex is one of the few objective indicators of afferent input from the retina and optic nerve. Since the pupillary light reflex is processed through the retina, it may be used to assess visual integrity (1). Pupillometry is a reliable technology capable of providing repetitive data on quantitative pupillary function in states of health and disease (2). Amplitude, latency, maximum constriction velocity, mean constriction velocity, and dilation velocity are measured using the Neuroleptics pupillometer. The effects of varying levels of ambient light on these parameters of the pupillary response have not been extensively studied. The purpose of this investigation is to determine the effects of varying luminescent levels on the pupillary response.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* recent bout of conjunctivitis or infection in the eye recent eye surgery seizure disorder unable to lie flat for 30 minutes known history of eye disease which cannot be corrected with lenses

Primary outcomes:
measure: pupillary light reflex: amplitude, latency, maximum constriction velocity, mean constriction velocity and dilation velocity during different levels of ambient light
timeFrame: Pupillometry readings will be taken at 3 potential light readings low light, intermediate light and high ambient light. A total of 48 readings will be done. All parameters will be done at one sitting and will take approximately 45 minutes to complete.
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: UMDNJ-University Hospital
state: New Jersey
Study officials:
affiliation: UMDNJ-NJMS
name: Lawrence W Chinn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05607017: Losartan in Prevention of Radiation-Induced Heart Failure
Official title: The Role of Losartan in the Prevention of Early Structural Changes Associated With Radiation-Induced Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Myocardial Fibrosis
Radiation-Induced Fibrosis
Keywords: Breast Cancer
Myocardial Fibrosis
Radiation-Induced Fibrosis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-11-07
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being done to see if losartan affects the chances of developing radiation-induced heart failure in patients who are receiving radiation therapy as part of standard of care treatment for breast cancer.

The interventions involved in this study are:

* Losartan
* Radiation Therapy (standard of care)

Detailed description: This is a pilot study examining whether losartan prevents radiation therapy-induced myocardial fibrosis (thickening of the heart tissue), which can cause heart failure, in breast cancer patients receiving radiation therapy.

Losartan is an U.S. Food and Drug Administration (FDA) approved drug used to treat hypertension (high blood pressure) and heart failure. The U.S. Food and Drug Administration (FDA) has not approved losartan for use in the treatment of breast cancer.

The FDA has approved radiation therapy as a treatment option for breast cancer.

The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. It is expected participants will be on the study for 1 year.

It is expected that about 10 people will take part in this research study.

Eligibility criteria: Inclusion Criteria:

-\>18 years of age

* Non-metastatic Breast Cancer patients who are scheduled to receive conventional left breast/chest wall RT inclusive of treatment to the internal mammary lymph nodes (IMNs)
* Prior chemotherapy is permitted
* Patients must have Left-sided Breast Cancer
* Ability to understand and the willingness to sign a written informed consent document
* No contraindication to MRI

Exclusion Criteria:

* Person who is pregnant or breastfeeding.
* Patient unable to swallow oral medication.
* Patients receiving any other investigational agent will not be excluded from study eligibility, unless the patient is already enrolled in an interventional study evaluating cardiac toxicity
* Patients already receiving ACE/ARBs.
* Patients with a history of allergic reactions to Losartan biosimilars.

Primary outcomes:
measure: Extracellular Volume (ECV) of Myocardial Fibrosis
timeFrame: 6 months
Secondary outcomes:
measure: Serum cardiac biomarker
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Rachel Jimenez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05584917: Physical Activity Return After Popliteal Artery Entrapement Syndrome Surgery
Official title: Physical Activity Return After Popliteal Artery Entrapement Syndrome Surgery With Tegner Activity Scale
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Popliteal Artery Entrapment
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2022-10-18
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: evaluation of physical activity return after popliteal artery entrapement syndrome surgery with the tegner activity scale


Eligibility criteria: Inclusion Criteria:

* popliteal artery entrapement syndrome surgery between 2010 and 2020 at the university center of Angers

Exclusion Criteria:

* denied to participate

Primary outcomes:
measure: comparison
timeFrame: change from baseline of the tegner activity scale 1 year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
References: