louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02366650: Help in the Emergency Room to Detect Organ Dysfunction
Official title: Help in the Emergency Room to Detect Organ Dysfunction - The HERO Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Critical Illness
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2015-02-19
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: PROBABILITY_SAMPLE
Study population: Subject enrolment will be based on adult patients presenting to the emergency department at the different sites with suspicion of organ dysfunction or identified at the hospital wars/units.

Brief summary: The purpose of this prospective, non-interventional clinical study is to assess the clinical validity of a number of markers (including Heparin Binding Protein (HBP), Procalcitonin (PCT), C-reactive protein (CRP), White cell count (WCC) and lactate) for indicating the presence of organ dysfunction, or outcome, of patients with organ dysfunctions following emergency department admission or hospitalization. Secondary objectives are to identify novel putative biomarkers and to identify risk factors for negative long-term effects of acute critical illness The HBP assay is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Heparin Binding Protein in human plasma.


Eligibility criteria: Inclusion Criteria:

i) ≥18 years of age ii) 1 or more of the following criteria: Saturation\<90% without oxygen or \<93% with oxygen or reported saturation\<90%, Respiratory frequency \>25/min, Altered mental awareness, Heart rate \>120/min, Systolic blood pressure \<100 mm Hg. iv) informed consent.

Exclusion Criteria:

None

Primary outcomes:
measure: infection-induced organ dysfunction
timeFrame: 72 hours
Secondary outcomes:
measure: To compare the specificity, sensitivity and accuracy of HBP against other biochemical markers
timeFrame: 72 hours
measure: To investigate the specificity, sensitivity and accuracy in biochemical markers to predict mortality, ICU-care, days in hospital and the persistence of organ dysfunction.
timeFrame: 90 days
measure: To investigate and identify risk factors for a negative long-term (5-10 year) outcome.
timeFrame: 10 years
measure: • Organ dysfunction 24-36 and 72 hours after arriving at the hospital
timeFrame: 72 hrs
measure: • Primary diagnosis infection (y/n)
timeFrame: 72 hrs
measure: • number of days on ward and ICU
timeFrame: 90 days
measure: • number of days of antibiotics , time to effective antibiotics
timeFrame: 72 hrs
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: John Boyd
city: Helsingborg
country: Sweden
facility: Helsingborg
city: Lund
country: Sweden
facility: Lund ED
city: Bern
country: Switzerland
facility: Bern ED
Study officials:
References:
Clinical trial NCT00006508: Disorders of Systemic Glucose Balance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoglycemia
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-11-20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Primary purpose: DIAGNOSTIC

Brief summary: We wish to identify people with hypoglycemia (low blood sugar) and ultimately determine why the blood sugar levels are so low. To do so, we will contrast the responses of patients suspected to have hypoglycemia with those of healthy subjects during standardized tests. Those tests may include: 1) a controlled hypoglycemia produced by administration of insulin, a blood sugar-lowering hormone, and sugar, 2) a formula meal, and 3) a period of up to 72 hours without food.


Eligibility criteria: Inclusion Criteria:

* Patients with suspected hypoglycemia
* Healthy subjects (controls)
* Absence of known macrovascular disease or of known CNS disease by medical history, physical examination or ECG (exclusions for induced hypoglycemia)
* Ability to give informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
References:
Clinical trial NCT04372108: A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis
Official title: An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease and Ulcerative Colitis: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Crohn Disease
Colitis, Ulcerative
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2020-05-01
Enrollment: 1056
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include participants with Crohn's Disease (CD) or Ulcerative Colitis (UC) who are new users of ustekinumab and new users of the comparator drugs which will be identified from the Department of Defense (DoD) Electronic Health Records (EHR) database.

Brief summary: The purpose of this study is to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult participants with Crohn's disease (CD) or ulcerative colitis (UC).


Eligibility criteria: Inclusion Criteria:

* Adult men and women with CD or UC who are new users of ustekinumab or the comparator drugs during the study period
* Participants must have at least 1 year of enrollment history with the DoD EHR database immediately prior to new use (that is, exposure index date) of ustekinumab or the comparator drugs

Exclusion Criteria:

* Participants below 18 years of age on the exposure index date
* Participants who do not meet the definition for CD or UC prior to or on the exposure index date
* Participants with any records of human immunodeficiency virus (HIV) diagnosis, organ or tissue transplant, or malignancy (excluding non-melanoma skin cancer \[NMSC\]) at any time prior to or on the exposure index date
* Participants with a physician diagnosis of rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis within 12 months prior to or on the exposure index date
* In the analysis of infection outcomes, participants diagnosed with the same infection of interest both within 60 days prior to or on the exposure index date and within 60 days after the exposure index date will be excluded

Primary outcomes:
measure: Incidence Rate for Malignancy
timeFrame: Up to 10 years and 3 months
Secondary outcomes:
measure: Opportunistic Infection (OI)
timeFrame: Up to 10 years and 3 months
measure: Serious Infection
timeFrame: Up to 10 years and 3 months
Other outcomes:
Locations:
city: Portsmouth
country: United States
facility: NMCP
state: Virginia
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT01952808: Healthy Immigrant Families: Working Together To Move More and To Eat Well
Official title: Healthy Immigrant Families: Working Together To Move More and To Eat Well
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immigrant Physical Activity and Nutrition
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-09-30
Enrollment: 151
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This project will broadly explore the efficacy of community participation in the design and implementation of an intervention to improve physical activity and nutrition among immigrant and refugee (Hispanic, Somali, Sudanese, Cambodian) families in Rochester, Minnesota


Eligibility criteria: Inclusion Criteria:

* Minimum age of 11 years old
* Reside in a household with at least one adult and one child (11-18)
* Not planning to move from the area over the next two years
* Willing and able to participate in all aspects of the study
* Willingness to provide oral informed consent
* Hispanic, Sudanese, Somali
* Residing in Rochester, MN

Exclusion Criteria:

* Self-reported pregnancy
* Self-reported insulin-dependent diabetes
* Self-reported diagnosis of cancer within the past 3 years
* Answer of "yes" to the following question: "Do you know of any reason why you should not do physical activity? For example, would it be unsafe for you to do increased physical activity because of a health problem?"

Primary outcomes:
measure: Improved dietary quality
timeFrame: Baseline- 24 months
measure: Increased physical activity
timeFrame: Baseline- 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Irene Sia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wieland ML, Weis JA, Hanza MM, Meiers SJ, Patten CA, Clark MM, Sloan JA, Novotny PJ, Njeru JW, Abbenyi A, Levine JA, Goodson M, Porraz Capetillo MG, Osman A, Hared A, Nigon JA, Sia IG. Healthy immigrant families: Participatory development and baseline characteristics of a community-based physical activity and nutrition intervention. Contemp Clin Trials. 2016 Mar;47:22-31. doi: 10.1016/j.cct.2015.12.004. Epub 2015 Dec 4.
Clinical trial NCT03343808: Retrospective Study of the Results of Cooled Radiofrequency for Genicular Nerves Neurotomy in 40 Consecutive Patients With Osteoarthritis of the Knee and Painful Knee Arthroplasty
Official title: Pain Treatment With Cooled Radiofrequency in Osteoarthritis and Total Knee Arthroplasty: Case Series in Hospital Universitario de Son Espases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Keywords: Cooled radiofrequency
chronic knee pain
knee arthroplasty
genicular nerve
Lead sponsor: Hospital Son Espases
Sponsor class: OTHER
Collaborators: name: José Andrés López Riquelme
name: María del Pilar Sanchís Cortés
First posted: 2017-11-17
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The procedure was performed to 33 patients with OA (two of them with inflammatory causes) and in 7 patients with TKA (four with revised TKA).

Brief summary: Analyze the results of cooled radiofrequency in patients with chronic knee pain after one year of follow- up.

Detailed description: The investigators performed a retrospective case-series reviewed of 40 patients who underwent cooled RF of genicular nerves. The investigators evaluated results of the survey of quality of life (SF36), knee society score (KSS) and the Visual Analogue Scale (VAS).

Eligibility criteria: Inclusion Criteria:

* Chronic knee pain (older than 3 months, with no response to physiotherapy, medication or hyaluronic acid infiltration) with a pain intensity according to VAS\>7/10
* The radiological criteria were witness of OA with Kellgren-Lawrence index of 2 to 4.
* Painful TKA with no apparent cause and with a radiological image where a proper placement was observed

Exclusion Criteria:

* Infection or lymphangitis of the member
* Acute knee pain
* Corticoids or hyaluronic acid infiltration with a high molecular weight prior to the surgery
* Pregnancy
* Severe neurological or psychiatric disorders
* Patients with pacemakers

Primary outcomes:
measure: Treatment success was defined as the number of subjects whose knee pain is reduced by ± 50% based on the Visual Analogue Scale (VAS).
timeFrame: one year after the procedure
Secondary outcomes:
measure: Short Form (36) Health Survey
timeFrame: one year after the procedure
measure: Knee Society Score (KSS)
timeFrame: one year after the procedure
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Son Espases
name: Andrés Camprodón Alberca
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05317208: Prevalence of Periodontitis in Sample of Egyptian Population
Official title: Prevalence of Periodontitis on a Sample of Adult Egyptian Population: A Cross-sectional Study III
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 581
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All Adult patients attending at the diagnostic center at the Faculty of Dentistry above 18 years old.

Brief summary: Prevalence of Periodontitis on a Sample of Adult Egyptian Population: A Cross-sectional study

Detailed description: The aim of this study is to assess the prevalence, severity, and extent of periodontitis through full-mouth examination of CAL, and its association withsociodemographic, behavioral and environmental risk factors, in anEgyptian sample will be recruited from diagnostic center at Faculty of Dentistry, Cairo University, Egypt.

Eligibility criteria: Inclusion Criteria:

* - All Adult patients attending at the diagnostic center at the Faculty of Dentistry above 18 years old.

Exclusion criteria:

1. patients undergone periodontal therapy in the last 6 months.
2. patients with psychomotor dysfunction.
3. Patients less than 18 years old.
4. Edentulous patients

Primary outcomes:
measure: Quetionaire on Percentage of periodontitis on egypt
timeFrame: Two months
Secondary outcomes:
measure: Socioeconomic level and periodontitis (questionaire)
timeFrame: Two months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: lecturer
name: Reham O Ibrahim, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT07011108: Machine Learning for Estimating Cardiorespiratory Fitness in Patients With Obesity
Official title: Machine Learning for Estimating Cardiorespiratory Fitness in Patients With Obesity
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Obesity; Overweight
Keywords: Obesity; overweight; Cardiorespiratory fitness; VO2max; Machine learning; ML, web-application;
Lead sponsor: Sykehuset i Vestfold HF
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 1700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with obesity from Norway

Brief summary: The primary aim of this study is to develop an obesity-specific machine learning (ML) model capable of accurately estimating VO2max, a key indicator of cardiovascular fitness.


Eligibility criteria: Inclusion Criteria:

* diagnosed with severe obesity
* body mass index (BMI) ≥40.0 kg •m-2, or 35.0-39.9 kg •m-2 with at least one obesity-related comorbidity

Exclusion Criteria:

* not obese

Primary outcomes:
measure: Machine learning model to estimate vo2max
timeFrame: The project will be completed in 2027
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00135408: A Study of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide
Official title: Randomized, Double-Blind, Placebo-Controlled Phase II Study Comparing the Safety of MDX-010 (BMS-734016) Administered With or Without Prophylactic Oral Budesonide (Entocort EC) in Patients With Previously Treated Unresectable Stage III or IV Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malignant Melanoma
Keywords: Unresectable Stage III or IV Malignant Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Medarex
First posted: 2005-08-26
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine Efficacy, Safety and Tolerability of MDX-010 (BMS-734016) administered with or without Prophylactic Oral Budesonide.


Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic diagnosis of unresectable Stage III or IV malignant melanoma (excluding ocular melanoma)
* Flexible Sigmoidoscopy and colonic biopsy required

Exclusion Criteria:

* Patients with active, untreated central nervous system metastasis. Patients with autoimmune disease.

Primary outcomes:
measure: Rate of Grade 2,3,4 Diarrhea - patients on study drug.
Secondary outcomes:
measure: Safety monitored w/follow-up period. Assess Best Objective response, Disease control rate, progression free survival, overall survival, duration/best objective response, Time/best objective response. PK, immunogenicity & pharmacodynamic analysis
timeFrame: at Week 24
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Charlotte
country: United States
state: North Carolina
city: Seattle
country: United States
state: Washington
city: Kitchener
country: Canada
facility: Local Institution
city: Moncton
country: Canada
facility: Local Institution
city: Tel Aviv
country: Israel
facility: Local Institution
city: Forli
country: Italy
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Hull
country: United Kingdom
facility: Local Institution
Study officials:
References:
citation: Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.
Clinical trial NCT03286608: Polyphenols and Risk of Dementia
Official title: Pattern of Polyphenol Intake and the Long-term Risk of Dementia in Older Persons
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diet, Polyphenols, Flavonoids, Stilbenes, Aged, Dementia, Alzheimer's Disease, Epidemiology
Lead sponsor: University of Bordeaux
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 1329
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: population of older persons from the community, aged 65 years or more, living in the Bordeaux area (France)

Brief summary: This project aims to leverage existing data from a large observational prospective study on dementia, the Three-City study, to investigate the relationship between intakes of polyphenols and the risk to develop dementia in the 12 years following dietary assessment.

Detailed description: The study sample includes 1,329 subjects followed for up to 12 years fro dementia after dietary assessment. The aim is to identify a pattern of polyphenol intake (based on 26 flavonoid and non-flavonoid polyphenol subclasses ascertained using a 24-hour dietary recall) associated with the risk of dementia and AD over 12 years in the 3C Bordeaux cohort.

Eligibility criteria: Inclusion Criteria:

* 65 years or more, live in Bordeaux area (France)

Exclusion Criteria:

* with dementia at the time of dietary assessment in year 2001-2002

Primary outcomes:
measure: incidence of dementia
timeFrame: 12 years
Secondary outcomes:
measure: incidence of Alzheimer's disease
timeFrame: 12 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04961008: Bottle PEP in Cystic Fibrosis
Official title: Safety and Sustainability in Bottle PEP in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 34
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aims to investigate the sustainability of Bottle-PEP in patients with cystic fibrosis


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cystic fibrosis
* Acute exacerbation

Exclusion Criteria:

* Any contraindication using the Bottle - PEP such as the presence of pneumothorax

Primary outcomes:
measure: 6 minute walk test
timeFrame: every 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
Study officials:
References:
Clinical trial NCT04214808: To Evaluate the Pharmacokinetics and Safety of AD-208
Official title: A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of AD-208
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Androgenetic Alopecia
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-02
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate pharmacokinetics and safety of AD-208.

Detailed description: The purpose is that pharmacokinetics and safety of AD-208 in healthy adult male volunteers are evaluated as compared to Avodart Soft Capsule 0.5mg.

Eligibility criteria: Inclusion Criteria:

* Healthy male Adult aged between 19 to 50 at the time of screening visit
* Weight over 50kg and Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit
* No evidence of medical symptoms or signs of congenital or no chronic disease

Exclusion Criteria:

* If having a clinically significant disease or medical history for blood/tumor, genitourinary systen, liver/biliary system, kidney, respiratory system, alimentary system, endocrine system, immune system, cardiovascular system, nervous system, skin and psychical disorder, etc

Primary outcomes:
measure: Area under the curve in time plot (AUCt)
timeFrame: Pre-dose(0 hour) to 72 hour
measure: Peak Plasma Concentration (Cmax)
timeFrame: Pre-dose(0 hour) to 72 hour
Secondary outcomes:
measure: Area under the curve in time plot (AUCinf)
timeFrame: Pre-dose(0 hour) to 72 hour
measure: Time to reach Cmax(Tmax)
timeFrame: Pre-dose(0 hour) to 72 hour
measure: Effective half-life(t1/2)
timeFrame: Pre-dose(0 hour) to 72 hour
measure: Clearance(CL/F)
timeFrame: Pre-dose(0 hour) to 72 hour
measure: Volume of distribution(Vd/F)
timeFrame: Pre-dose(0 hour) to 72 hour
Other outcomes:
measure: Number of participants with adverse events
timeFrame: From Day -1 until Day 59
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
affiliation: Kyungpook National University Hospital
name: Young-Ran Yoon, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: