louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03354000: An RCT of an Online Training for Vulnerable Patients to Use an Online Patient Portal Website
Official title: Engaging Diverse Patients in Using an Online Patient Portal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electronic Health Records
Chronic Disease
Health Literacy
Keywords: Patient Portal
Healthcare disparities
Safety net healthcare system
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Online patient portals are becoming ubiquitous in the US. Previous research has documented substantial usability barriers, especially among patients with limited health literacy. This pilot randomized pilot trial had the goal of determining the effectiveness of an in-person training with a scalable online video-based training program to increase portal use among patients in a safety net healthcare setting.

Detailed description: The intervention in this study was a patient portal training curriculum with simple instructions and 11 how-to videos for accessing features of an online patient portal. Using a deeply participatory approach, this curriculum was created in consultation with a patient advisory board from the San Francisco Health Network, a local Medicaid health plan. From June until October 2016, 93 patients with 1 or more chronic diseases were randomized to receive either: 1) an in-person tutorial with a trained research assistant versus 2) a link to view the videos on their own. The primary outcome was portal log-in (yes/no) between 3 and 6 months post-training, assessed through a portal administrative dashboard within the EHR. Secondary outcome included baseline and follow-up survey measures on participants' perceptions of the portal use and their care, as well as views of the web-based lessons.

Eligibility criteria: Inclusion Criteria:

* English-speaking as portal is only available in English
* diagnosed with at least one chronic condition

Exclusion Criteria:

* cognitive impairment
* visual impairment
* severe mental health conditions
* any circumstances that would make participation in the study difficult
* no previous email use
* self-reported usage of MYSFHEALTH

Primary outcomes:
measure: Portal log-ins
timeFrame: 3-6 months post-training
Secondary outcomes:
measure: eHealth Literacy
timeFrame: 3-6 months post-training
measure: Portal sign-up
timeFrame: 3-6 months post-training
measure: Digital literacy skills
timeFrame: 3-6 months post-training
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Courtney Lyles, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Norman CD, Skinner HA. eHEALS: The eHealth Literacy Scale. J Med Internet Res. 2006 Nov 14;8(4):e27. doi: 10.2196/jmir.8.4.e27.
Clinical trial NCT06320600: Precision Medicine of Diabetes Program in China
Official title: Precision Medicine of Diabetes Program in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 120000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The retrospective cohort includes patients diagnosed with diabetes according to WHO 1999 criteria, and the prospective cohort enrolls precisely classified diabetic patients according to "Classification of diabetes mellitus in China: an expert consensus statement".

Brief summary: The prevalence of diabetes has been increasing year by year. According to the International Diabetes Federation (IDF) statistics in 2021, the global number of people with diabetes has reached 537 million. The patient population is large and heterogeneous, and precise diagnosis and treatment of diabetes patients have been a focus of attention. The objective of this study is to clarify the current status of precision classification and diagnosis of diabetes patients through retrospective and prospective cohort studies, and to establish a model for precision classification and diagnosis of diabetes, improving the accuracy of diabetes classification and diagnosis; based on big data of precision medicine for diabetes patients and follow-up cohorts, to establish precise diagnostic, therapeutic, and predictive methods for diabetes; and through multi-omics data analysis, to explore the potential pathogenesis of diabetes, explaining the heterogeneity of patients, and guiding individualized treatment for patients.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with diabetes according to WHO 1999 criteria

Exclusion Criteria:

* with duration more than 1 year; Diabetes has not been diagnosed by WHO standards in 1999; Absence of medical history data

Primary outcomes:
measure: The currency analysis of diabetes classification
timeFrame: July 1st 2023 to December 31th 2023
Secondary outcomes:
measure: To establish a model for predicting diabetic retinopathy
timeFrame: January 1st 2024 to December 31th 2028
measure: To establish a model for predicting diabetic kidney disease
timeFrame: January 1st 2024 to December 31th 2028
measure: To establish a model for predicting diabetic neuropathy
timeFrame: January 1st 2024 to December 31th 2028
Other outcomes:
measure: To establish a model for hypoglycemic therapy
timeFrame: January 1st 2024 to December 31th 2028
Locations:
city: Changsha
country: China
facility: the Second Xiangya Hospital
state: Hunan
Study officials:
References:
Clinical trial NCT03269500: Evaluation of the Applicability of Personalized Tools About Nutrition Education for Malnourished Older People
Official title: Evaluation of the Applicability of Personalized Tools About Nutrition Education for Malnourished Older People
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malnutrition of Mild Degree
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2017-08-31
Enrollment: 42
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: malnourished elderly present on hospital day care

Brief summary: Describe the frequency of use of nutrition education tools for undernourished older people

Detailed description: The description of the population will identify the characteristics of patients who use the tools and guide their use in patient care. To realize an impact assessment, It necessary to identify specific criteria for inclusion. It is important initially to assess the use of the nutritional tools. The assessment of performance (obstacles and understanding), will be used to improve tools to optimize their use.

Eligibility criteria: Inclusion Criteria:

* Subject of 75 years or more.
* Hospitalized geriatric day hospital.
* Living at home, within a radius of 40 km around the hospital Xavier Arnozan.
* Subject or caregiver (s) read, understand and speak the french.
* Undernutrition (criteria of the French high authority for health (HAS) 2007)
* Agreed to participate in the study: compendium of the opposition

Exclusion Criteria:

* Subject not wishing to participate in the study,
* MMSE (Mini Mental State Examination) \< 20, without presence of a caregiver with no cognitive problems scoring.
* Identified palliative care.
* Presenting a contraindication to oral feeding.
* Presence of supply of enteral or parenteral.
* Presence with a diagnosis of severe psychiatric pathology.
* Already participating in a study on undernutrition.
* One against medical advice.

Primary outcomes:
measure: Frequency of use of the booklet and platelets
timeFrame: Day 14
Secondary outcomes:
measure: Evaluation of the knowledge following the delivery of the tools
timeFrame: Day 14
measure: Instrumental Activities of Daily Living
timeFrame: Day 1
measure: Assessment of quality of life scale
timeFrame: Day 1
Other outcomes:
Locations:
city: Pessac
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Ornella SARRY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02216500: Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
Official title: Precision Ketogenic Therapy Effects on Electrical and Metabolic Abnormalities in Epilepsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Seizures
Keywords: Ketogenic Therapy
Ketogenic Diet
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 400
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Approximately a fourth of children with seizures do not respond adequately to available therapy. Ketogenic therapy has a long history as treatment for intractable epilepsy, but there is no agreement concerning how it works and what is the best way to administer it. This natural history study will collect data pertaining to both questions.

Detailed description: The basis of Ketogenic Therapy is an altered macronutrient intake. It is based on a ratio of fat: protein+carbohydrate in which protein intake is adequate and carbohydrate is minimal. On Ketogenic Therapy, the body metabolizes fat, producing ketones as an energy source for the brain. Induction of ketosis has been shown to correlate with the reduction of seizures observed with Ketogenic Therapy. A major challenge of Ketogenic Therapy in children is that the compounds provided to stop seizure activity are the same compounds provided for growth and development. The altered macronutrient ratio that is the basis of Ketogenic Therapy is also a potential risk factor for dyslipidemia and may adversely affect growth. The investigators will evaluate efficacy of Ketogenic Therapy by assessing seizures and requirements for antiepileptic drugs. The investigators will evaluate adverse effects of Ketogenic Therapy by assessing dyslipidemia and growth. The investigators will foster optimal daily administration of therapy with structured training programs for caregivers.

Eligibility criteria: Inclusion Criteria:

* Patients whose physician has prescribed the ketogenic diet
* Patients with lab tests consistent with the ability to metabolize a high fat and low carbohydrate diet
* Patients that can be compliant with administration of the therapy and with record keeping.

Exclusion Criteria:

* Patients with lab tests consistent with the inability to metabolize a high fat and low carbohydrate diet
* Patients at risk of being non-compliant with administration of the therapy and with record keeping

Primary outcomes:
measure: Reduced seizures
timeFrame: 2 years
Secondary outcomes:
measure: Reduced requirement for medications
timeFrame: 2 years
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Peggy R. Borum, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02382900: Two-dose Schedule of Quadrivalent HPV Recombinant Vaccine in 11-year-old Boys in Mexico City
Official title: Evaluation of a Two-dose Schedule of Quadrivalent Human Papilloma Virus (Types 6, 11, 16, 18) Recombinant Vaccine in 11-year-old Boys in Mexico City (Gardasil® Merck and Co.).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Human Papilloma Virus
Keywords: quadrivalent
vaccine
Lead sponsor: Universidad Nacional Autonoma de Mexico
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: Secretaria de Salud, Mexico
First posted: 2015-03-09
Enrollment: 500
Sex: ALL
Minimum age (years): 10
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the genital tract human papilloma virus (HPV), especially types 6 and 11 cause genital warts, the commonest viral sexually transmitted disease. The HPV 16 and 18 are the most common oncogenic "high-risk" genotypes and cause approximately 70% of all cervical cancers despite the fact that are associated with other anogenital cancers, anus, vagina, vulva and penis, and cancers of the head and neck. Current estimates are that 5.2% of all cancers are HPV associated. A large number of studies, including both adult and young females, have demonstrated that HPV vaccines are highly immunogenic and induce a long lasting protection against infection. Immunogenic vaccination results in young men and boys are equally satisfactory with the quadrivalent HPV (types 6, 11, 16, 18) vaccine recommended for men. The recommended vaccination scheme includes three shots giving the second at two months and the third at six months after the initial shot. Recently, it has been shown that the use of a two shot scheme (0 and 6 months) is equally effective among girls. The purpose of this study is to determine that the immunogenicity is non-inferior in boys using a two shot scheme compared with young women and girls.


Eligibility criteria: Inclusion Criteria:

* All those children whose parents accept their participation in the study.

Exclusion Criteria:

* Fever,
* previous vaccination against HPV,
* allergy to vaccine components,
* thrombocytopenia,
* immunosuppression,
* diarrhea,
* vomiting,
* dyscrasia,
* administration of another anti-viral vaccine in the previous 15 days.

Primary outcomes:
measure: Immunogenicity (Geometric mean antibody concentration will be compared between the two groups)
timeFrame: 7 months (1 month after the last dose)
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Malaquias Lopez Cervantes
state: Mexico city
Study officials:
References:
Clinical trial NCT00018200: Effect of Antidepressants on Back Pain
Official title: Efficacy of Antidepressants in Chronic Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Back Pain
Sciatica
Keywords: analgesia
Back pain
sciatica
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Enrollment: 130
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether different types of antidepressant medicines relieve back pain that has lasted at least six months on a daily basis. Study participants will be assigned to treatment with either a antidepressant acting on the serotonin system in the brain (fluoxetine), one acting on the noradrenaline system (desipramine, or to a control medication not expected to relieve pain (benztropine). Each participant will be seen at least nine times during their 12 weeks on medication. This is a phase 2/3, outpatient study.


Eligibility criteria: Inclusion Criteria:

* Chronic back pain (pain on a daily basis for six months or longer)
* Age 18-65
* No major medical illness

Exclusion Criteria:

* medical contraindication to tricyclic antidepressants
* recent alcohol or substance use disorder
* bipolar disorder

Primary outcomes:
measure: Descriptor Differential Scale Pain Intensity
timeFrame: 12 weeks post baseline
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego
name: Joseph H. Atkinson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Atkinson JH, Slater MA, Capparelli EV, Wallace MS, Zisook S, Abramson I, Matthews SC, Garfin SR. Efficacy of noradrenergic and serotonergic antidepressants in chronic back pain: a preliminary concentration-controlled trial. J Clin Psychopharmacol. 2007 Apr;27(2):135-42. doi: 10.1097/jcp.0b013e3180333ed5.
Clinical trial NCT04794400: The Application of a Mask in Patients With Severe Covid-19 Already Treated With High-flow Nasal Cannula.
Official title: The Application of a Mask in Patients With Severe Covid-19 Already Treated With High-flow Nasal Cannula.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: Critical care
Non-invasive ventilation
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients with severe hypoxemic respiratory failure due to Covid-19 are often treated with oxygen delivered through a high-flow nasal cannula (HFNC). This is according to guidelines. We have made the clinical observation that oxygenation sometimes improves when a mask (e.g. oxygen mask or inhalation mask) is applied on top of the HFNC. This has quickly become a clinical routine at intermediary care units at our hospital, where patients with HFNC are offered to test the intervention (mask + HFNC) as part of clinical routine.

This study aims to evaluate this new routine in a standardised way.

Detailed description: Patients with severe covid-19, treated with HFNC, will be approached for consent. If inclusion critera and no exclusion criteria are fulfilled, baseline measurements will be taken without mask, including arterial blood gas analysis (ABG)

Then a simple oxygen mask will be applied covering nose and mouth, without providing supplemental oxygen. After 30 minutes with mask + HFNC, new measurements will be taken, including ABG.

After 30 minutes, the mask is removed and when steady state occurs, new measurements will be taken, without ABG. Then, the patients could continue using the mask as part of clinical routine

Eligibility criteria: Inclusion Criteria:

* Verified Covid19 infection
* treatment with HFNC
* Estimated P/F ratio of ≤ 13 KPa

Exclusion Criteria:

* language barrier
* unable to provide consent
* risk of deterioration due to study

Primary outcomes:
measure: Oxygenation
timeFrame: 30 minutes
Secondary outcomes:
measure: Carbon dioxide
timeFrame: 30 minutes
measure: SpO2
timeFrame: 60 minutes
measure: Respiratory rate
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skåne University Hospital
state: Skåne
Study officials:
affiliation: Region Skåne
name: Gustav Torisson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01755000: Study of Hypotensive Hematopoietic Malignancy Patients' USCOM Readings
Official title: A Pilot Feasibility Study of Hypotensive Hematopoietic Malignancy Patients' USCOM Readings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukemia
Lymphoma
Paraproteinemias
Multiple Myeloma
Myelodysplastic Syndromes
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2012-12-21
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to test how practical it is to use the Ultrasonic Cardiac Output Monitor (USCOM), an FDA-approved device, on oncology patients (specifically those with blood cancers). Additionally, the researchers will learn if the USCOM gives additional information about patients' conditions when their blood pressures drop and they are treated with intravenous fluids.


Eligibility criteria: Inclusion Criteria:

-≥ 18 years of age

* English speaker
* Diagnosis of blood dyscrasia, hematopoietic malignancy, or condition that may requires HSCT

Exclusion Criteria:

* Obstruction of the suprasternal notch that prevents placing the USCOM probe in the correct location
* Tracheostomy or endotracheal tube that prevents placing USCOM probe in the correct location
* Inability to lie flat, on left or right side, or with the head of bed at a 30 degree angle for the USCOM exam (ex. due to respiratory distress or physiologic reasons)
* Impairment by a psychiatric, cognitive, or physiologic disorder that limits ability to understand explanation of study and give consent

Primary outcomes:
measure: What is the inter-rater agreement between multiple independent USCOM users measuring stroke volume (SV) and peak velocity (Vpk) whose systolic blood pressures (SBPs) and mean arterial pressures (MAPs) are stable (SBP above 95 mmHg and MAP above 65 mmHg)?
timeFrame: 1 day (one time event for patient)
measure: What is the inter-rater agreement between multiple independent USCOM users measuring SV and Vpk in hematopoietic malignancy patients whose SBPs drop below 95mmHg or MAPs drop below 65mmHg?
timeFrame: 1 day (one time event for patient)
measure: In what percentage of patients is fluid bolus administration successful as measured by the current standard of care (MAP) and what is the level of agreement between the standard measure and USCOM readings in determining return to hemodynamic stability?
timeFrame: 1 day (one time event for patient)
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Michelle Parmentier, RN, BSN
role: PRINCIPAL_INVESTIGATOR
References: