louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04952376: Equitable Access to COVID-19 Vaccines
Official title: Enabling Equitable Access to COVID-19 Vaccine in Under-Resourced Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Adelante Healthcare
First posted: 2021-07-07
Enrollment: 1722
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: Patient is informed via SMS of vaccine availability and advised to schedule an appointment.

Arm 2: Same as Arm 1 but delivered as a personalized message text from the PCP. Arm 3: Patients assigned to Arm 3 will receive the same message in the Arm 2 intervention. In addition, they will be given interactive or 2-way SMS options to obtain additional information about COVID vaccine.
Primary purpose: PREVENTION

Brief summary: This study will deploy a multimodal pragmatic intervention to improve vaccine uptake in priority populations and address vaccine hesitancy to improve access by using a proactive organized population-based outreach leveraging health information technology with tailored navigation support to address mistrust and social barriers.

Detailed description: This study will deploy a multimodal pragmatic intervention to improve vaccine uptake in priority populations through a proactive organized population-based outreach approach. It will leverage health information technology with tailored navigation support to address mistrust and social barriers. Study key objectives are to:

1. conduct a survey of patients to assess and track barriers, intent, and sources of information on COVID vaccine over time.
2. Determine whether a primary care physician (PCP) endorsement with or without interactive digital communication plus navigation is more effective in promoting uptake of COVID-19 vaccine than general messages from the clinic. Patients will be randomized to one of three arms:

   1. Arm 1: Message about vaccine availability delivered by SMS advising patients to make an appointment.
   2. Arm 2: Same as Arm 1 but delivered as a personalized message text from the PCP.
   3. Arm 3: Same as Arm 2 plus a interactive 2-way SMS options.

Eligibility criteria: Inclusion Criteria: 18 years and older, receiving care at Adelante Healthcare and not vaccinated or already scheduled for vaccination through the health center's appointment system Exclusion Criteria: Patient younger than 18 or who have been previously or are selected for vaccination during or prior to the week of study enrollment

Primary outcomes:
measure: Dose 1 COVID-19 Vaccine
timeFrame: 30 days
Secondary outcomes:
measure: Dose 2 COVID-19 Vaccine
timeFrame: 60 days
Other outcomes:
measure: Engagement
timeFrame: 30 days
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Chyke Doubeni, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00644176: A Randomized, Open Label, Clinical Trial of the Pharmacokinetics of Azithromycin Following a Single Dose of Azithromycin Sustained Release (2 Gram) or Commercial Azithromycin Tablet (500 mg) to Cancer Patients That Require Lung Surgery
Official title: A Randomized, Open Label, Clinical Trial of the Pharmacokinetics of Azithromycin in Serum, Bronchial Washings and Lung Tissue Following a Single Dose of Azithromycin Sustained Release (2 Gram) or Commercial Azithromycin Tablet (500 mg) to Cancer Patients That Require Lung Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-26
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this trial was to characterize the pharmacokinetics of the currently marketed azithromycin immediate release tablet formulation (AZ-IR) versus the azithromycin sustained release liquid formulation (AZ-SR) in lung tissue and bronchial washings, the latter consisting of the epithelial lining fluid (ELF) and cellular elements, mainly alveolar macrophages (AM).


Eligibility criteria: Inclusion Criteria:

Inclusion criteria were hospitalized subjects diagnosed with lung cancer that had consented to surgery requiring lung resection who had a life expectancy of \>6 months.

Exclusion Criteria:

Key exclusion criteria were antibiotic prophylaxis prior to surgery, diffuse, non-infectious lung disease, history of cigarette smoking of \>5 packs per year, patients with any infectious disease that required antibiotic therapy, administration of drugs known to interfere with azithromycin pharmacokinetics, and subjects on chemotherapy.

Primary outcomes:
measure: Azithromycin Cmax, Tmax, AUC72, (or AUClast for serum) and AUC24 from serum
timeFrame: predose, and at and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose
measure: Azithromycin Cmax, Tmax, AUC72, and AUC24 in epithelial lining fluid and alveolar cells from bronchoalveolar lavage and lung tissue samples
timeFrame: 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose
Secondary outcomes:
measure: 12-lead electrocardiograms (ECGs)
timeFrame: Screening and 72 hours postdose
measure: adverse events (AEs)
timeFrame: Treatment day 0, and at 2, 4, 8, 12, 16, 24, 48, and 72 hours postdose
measure: safety laboratory tests
timeFrame: Treatment day 0 and 72 hours postdose
measure: vital signs
timeFrame: Screening and Treatment day 0
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00532376: fMRI Investigation of Depression in Patients With Epilepsy
Official title: fMRI Investigation of Depression in Patients With Epilepsy
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Epilepsy
Depression
Keywords: epilepsy
depression
fMRI
emotion
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2007-09-20
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Depression is very common in epilepsy. Depression is the strongest predictor of poor quality of life in patients with epilepsy. The biological basis for depression in epilepsy remains poorly understood. This study uses functional MRI (fMRI) to examine brain response to emotional and non-emotional stimuli in healthy control subjects and in patients with epilepsy who are either depressed or not depressed. Results from this study will contribute to a better understanding of depression in epilepsy, which may eventually inform development of better treatment modalities..



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Citigroup Biomedical Imaging Center at 516 East 72nd Street
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Tracy A Butler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03482076: Iron Deficiency Anemia in Childern With Liver Cirrhosis
Official title: Prevelance of Iron Deficiency Anemia in Liver Cirrhosis in Childern
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Iron Deficiency, Anaemia in Children
Liver Cirrhosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-03-29
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Iron deficiency anemia is a common complication of liver cirrhosis in childern and may affects there life this study to improve the outcome of these patients

Detailed description: Patients with cirrhosis are at risk of developing both IDA and anemia of chronic disease concomitantly, and there adverse effects can deteriorate general condition and affect of quality of life in these patients .Also because it is easier to correct IDA than anemia of chronic disease, so this study of the prevalence of IDA helping us in the diagnosis and treatment of IDA and can reduce the need for other diagnostic tests and improve the quality of life in patients with cirrhosis .

Eligibility criteria: Inclusion Criteria:

* all childern with liver cirrhosis in GIT and hepatology unit

Exclusion Criteria:

* Neonates less than one month
* childern with other liver diseases

Primary outcomes:
measure: Prevelance of IDA in liver cirrhosis
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01040676: Automated Telephone Nutrition Support
Official title: The Use Of Automated Telephone Nutrition Support In Spanish-Speaking Latino Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Telephone
Nutrition Support
Automated
Low English Proficiency
Hispanic
Latino
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-12-29
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Automated Telephone Nutrition Support (ATNS) study investigates the effect of automated telephone nutrition support on diet and glycemic control among Spanish-speaking diabetics in Oakland.

Detailed description: The Automated Telephone Nutrition Support (ATNS) study is a joint effort between the University of California at San Francisco, La Clinica de la Raza, and patients living with diabetes in Fruitvale (Oakland). Our goal is to see if motivated people with diabetes are able to get their blood sugar under better control by choosing a healthier diet. Since it's hard to eat a healthy diet, one of the ways we are trying to help is by calling people, having them record what they've eaten, and reminding them of the right foods to eat. The innovative part is using an automated telephone system to call them to have them record their dietary choices and giving them feedback immediately regarding what to modify as appropriate.

Eligibility criteria: Inclusion Criteria:

* Age \>18.
* Diabetic with A1c \>8.5 for at least 1 year based on clinic records.
* Spanish-speaking (self-defined)

Exclusion Criteria:

* No telephone at home
* Planning to be out of town for longer than 2 weeks in the coming 12 weeks and thus unable to take part in follow up
* Pregnancy
* Insulin-dependent Diabetes
* Any evidence of end organ damage including chronic kidney disease requiring dialysis, congestive heart failure, or cirrhosis.

Primary outcomes:
measure: Hemoglobin A1c
timeFrame: 12 weeks
Secondary outcomes:
measure: Weight
timeFrame: 12 weeks
measure: Body Mass Index
timeFrame: 12 weeks
measure: Blood Pressure
timeFrame: 12 weeks
measure: Low Density Lipoprotein-calculated (LDL-c)
timeFrame: 12 weeks
measure: C-reactive Protein
timeFrame: 12 weeks
measure: Waist Circumference
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Oakland
country: United States
facility: La Clinica de la Raza
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ralph Gonzales, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04211376: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Anxiety
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Anxiety
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Anxiety
Anxiety Disorders
Anxiety Depression
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with anxiety

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to infection with anxiety

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study

   a. May be signed by parent or legal guardian in the case of minor or adult unable to provide consent
2. Male or female of all ages
3. Diagnosis of anxiety based on DSM-V criteria

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition

Primary outcomes:
measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00536276: Evaluation of Vitamin D Status in Children With Acute Burns
Official title: Vitamin D Deficiency in Acutely Injured Pediatric Burn Patients: Incidence, Etiology, Metabolic Sequelae and Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Burns
Bone Demineralization
Keywords: vitamin D
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2007-09-27
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To see which vitamin D supplement (D2 vs D3) is most beneficial in burned children.

Detailed description: The purpose of this study is to follow up our descriptive observations with a prospective randomized double blinded study to verify our clinical perception that hypovitaminosis D is prevalent postburn and to evaluate whether therapeutic supplementation will enhance specific primary outcome measures during burn convalescence.

Eligibility criteria: Inclusion Criteria:

* Child is \> 6 months of age but \< 19 years old
* Burn injury \> 30% total body surface area
* Admitted to SHC within 4 days of injury
* Attending physician decision that patient is likely to survive
* Parents or legal guardian give informed consent along with assent of the child as applicable

Exclusion Criteria:

* Attending physician decision that patient is not likely to survive
* Prior history of anticonvulsant or glucocorticoid use, gastric/bowel resection, parathyroid disease, liver disease, chronic renal failure or prior pharmacologic vitamin D use (\>1000 IU/D)

Primary outcomes:
measure: Examine the effect of D2 vs D3 supplementation on serum 25-OH and 1,25 OH vitamin D levels
timeFrame: During acute phase postburn
Secondary outcomes:
measure: Identify the most efficacious vitamin D analogue in terms of preventing deterioration of bone markers
timeFrame: During acute phase postburn
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Shriners Hospital for Children
state: Ohio
Study officials:
affiliation: Shriners Hospital for Children
name: Michele M Gottschlich, PhD, RD, CNSD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gottschlich MM, Mayes T, Khoury J, Warden GD. Hypovitaminosis D in acutely injured pediatric burn patients. J Am Diet Assoc. 2004 Jun;104(6):931-41, quiz 1031. doi: 10.1016/j.jada.2004.03.020.
citation: Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
Clinical trial NCT00325260: Non-Inferiority Study Comparing the Subunit Vaccines Influvac and Agrippal in China
Official title: A Randomized, Endpoint-Blind, Parallel Group Study to Demonstrate the Non-Inferiority of the Subunit Influenza Vaccine Influvac® to the Subunit Influenza Vaccine Agrippal® in Healthy Children, Adults and Elderly in China.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: influenza
non-inferiority
Influvac
Agrippal
healthy subjects
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-05-12
Enrollment: 900
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the study Influvac will be compared to Agrippal, another subunit influenza vaccine that is already on the market in China. The main objective of the study is to show that both vaccines are comparable with regard to efficacy. In addition, safety and efficacy data with Influvac will be assessed in the Chinese population.


Eligibility criteria: Inclusion Criteria:

* signed and dated informed consent
* being healthy
* mental health enough to understand the study, the informed consent form and the questionnaire

Exclusion Criteria:

* known to be allergic to constituents of the vaccine
* having an autoimmune disorder, taking immunomodulating drugs or having immune disfunction secondary to HIV
* having had a documented serious adverse reaction to previous influenza vaccination
* having had documented influenza infection or vaccination in the six months prior to the start of the study
* having received any other vaccines, immunoglobulins or investigational drugs in the month prior to the start of the study

Primary outcomes:
measure: HI titers 4 weeks after vaccination (efficacy) and safety and tolerability
Secondary outcomes:
measure: HI derived parameters: seroprotection, seroconversion and mean fold increase 4 weeks after vaccination
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Site 1
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT02008760: QOL, ADL and Pain Before and After Intervention With N3 From Krill With D3.
Official title: Survey of Chronic Pain Patients' Self-rated Quality of Life, ADL Function and Pain Before and After Intervention With Omega 3 Fatty Acids From Krill With Vitamin D3
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Quality of Life
Pain
Keywords: pain
quality of life
ADL
DOLO test
compliance
D3
Lead sponsor: Hospitalet Valdemar
Sponsor class: INDUSTRY
First posted: 2013-12-11
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of this project is investigation of patients' with chronic pain self-rated quality of life, ADL function and level of pain before and after 3 months of intervention with N-3 fatty acids from krill in combination with vitamin D3. Furthermore, the compliance of the patients and the effect of the intervention on the patients' vitamin D status and cardiovascular risk factors are studied.


Eligibility criteria: Inclusion Criteria:

* 18 year +
* can read and understand danish

Exclusion Criteria:

* shellfish allergy
* intake of anticoagulants and vitamin D
* pacemaker
* participating other studies

Primary outcomes:
measure: ADL function on a scale 0-11
timeFrame: february 2013-february 2014
measure: pain on a scale 0-100 mm
timeFrame: february 2013-february 2014
measure: Quality of life on a scale 0-100
timeFrame: february 2013-february 2014
Secondary outcomes:
measure: compliance in %
timeFrame: february 2013-february 2014
measure: changes at D3 levels
timeFrame: february 2013-february 2014
Other outcomes:
Locations:
city: Ringsted
country: Denmark
facility: Hospitalet Valdemar
Study officials:
affiliation: Hospitalet Valdemar
name: Henrik Nielsen, C physician
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05436860: PreDEA Study, Prevention in Emergency / Acceptance Departments: the Case of Hepatic Steatosis
Official title: Pre- Emergency / Acceptance Departments Study, Prevention in Emergency / Acceptance Departments: the Case of Hepatic Steatosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatic Steatosis
Lead sponsor: University of L'Aquila
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 20189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to Emergency department ,over 18, in white or green code

Brief summary: Our study aims to evaluate whether the Emergency Department (PS) can support the health system to improve the prevention and management of chronic inflammatory diseases and ensure actions aimed at screening, raising awareness and informing the population.

Specifically, the determination of the prevalence of a widely diffused pathology such as fatty liver disease aims to be the precursor of future pilot studies aimed at evaluating the advantages and critical issues of the PS as a prevention tool.


Eligibility criteria: Inclusion Criteria:

* Patients over 18
* Patients admitted to Emergency department in white or green code

Exclusion Criteria:

* Patients under 18
* Patients admitted to Emergency department in yellow or red code

Primary outcomes:
measure: Evaluation of the number of steatotic patients who access the emergency room - Emergency room as a tool for early diagnosis of hepatic steatosis
timeFrame: 12 months
Secondary outcomes:
measure: Develop new prognostic algorithms for assessing the risk of major and minor clinical events in patients with fatty liver.
timeFrame: 36 months
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: Clara Balsano
state: Italy/L'Aquila
Study officials:
References: