louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05943483: To Establish the Traditional Chinese Medicine Based Intelligent Personal Health Care System
Official title: To Establish the Traditional Chinese Medicine Based Intelligent Personal Health Care System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traditional Chinese Medicine Body Constitution
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 1918
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The enrolled normal subjects were confirmed by the Association and the research Principal Investigator (PI). Subjects between the ages of 18 and 85 were included. We collected all of the subjects' basic information and administered the Chinese Medicine Constitution Assessment Scale.

Brief summary: Development of a New Generation Chinese Medicine Constitution Assessment Scale

Detailed description: Development of a New Generation Chinese Medicine Constitution Assessment Scale:

A. Analyzing the existing CCMQ and BCQ questionnaire syntax. B. Redesigning the scale's question statements. C. Reintegrating the scale items and constitutional characteristics. D. Testing and evaluating the reliability and validity of the questionnaire, cross-assessing with diagnoses from experienced Chinese medicine practitioners.

E. Collecting feedback and reviewing modifications based on the responses from the general population questionnaire.

Eligibility criteria: Inclusion Criteria:

* Aged over 18 and under 85.
* Participants agreed to join the trial by fully understanding the purpose of the study and the entire trial process and then signed an informed consent.
* Able to fill out online questionnaire with any electronic device in person or under assistance

Exclusion Criteria:

* Age of subjects was under 18 or more than 85 years old.
* Participants who do not meet the above criteria
* Subjects were not willing sign the informed consent.

Primary outcomes:
measure: Constitution in Chinese Medicine Questionnaire(CCMQ)_modified version
timeFrame: On the 1 day of receipt
Secondary outcomes:
measure: Base Data Questionnaire
timeFrame: On the 1 day of receipt
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
state: North District
Study officials:
References:
Clinical trial NCT02736383: Tranexamic Acid in Hip Fracture Surgery
Official title: Effectiveness of Tranexamic Acid (TXA) in Reducing Blood Loss in Hip Fracture Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fracture
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 142
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hip fractures

Brief summary: To determine if TXA utilization is effective at reducing transfusion rates in elderly patients undergoing surgery for treatment of a hip fractures.


Eligibility criteria: Inclusion Criteria:

* Acute, isolated, unilateral femoral neck, intertrochanteric, and per trochanteric hip fractures confirmed by anteroposterior/lateral hip radiographs, computed tomography, or magnetic resonance imaging.
* Age 65 and older
* Low energy mechanism of injury
* Hip fracture fixation performed within 48 hours
* English speaking
* Anticipated medical optimization for operative fixation
* No other major trauma

Exclusion Criteria:

* Retained hardware around the affected hip
* Infection around the affected hip
* Transfer patients with a length of stay \> 24 hours at the transferring hospital
* Diagnosis of deficient natural anticoagulation
* Known congenital thrombophilia (Deficiency of Protein C, S, Antithrombin)
* Known allergy to TXA
* Patients undergoing percutaneous pinning of the hip fracture

Primary outcomes:
measure: Blood Transfusion Rate
timeFrame: 6 weeks
Secondary outcomes:
measure: Hospital Length of stay
timeFrame: 6 weeks
measure: Post operative complications
timeFrame: 6 weeks
measure: Hospitalization costs
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Spectrum Health Hospitals
name: Blake W Miller, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01757483: Canadian Ticagrelor Survey
Official title: Effectiveness of Risk Minimisation Interventions for Ticagrelor in Canada
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-12-31
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All physicians who have prescribed at least one dose of ticargrelor and complete the Knowledge and understanding survey

Brief summary: This study is designed to evaluate the effectiveness of the current ticagrelor risk minimisation strategy in Canada through a prescriber knowledge and understanding (KAU) survey of selected important identified safety concerns (i.e., bleeding, dyspnea and drug interactions) and ASA dosage.

Detailed description: Effectiveness of risk minimisation interventions for ticagrelor in Canada

Eligibility criteria: Inclusion Criteria:

- N/A (All prescribers will be contacted for participation)

Exclusion Criteria:

- Participation in a previous wave of the survey.

Primary outcomes:
measure: KAU Questionnaire: Knowledge of the 4 key safety issues pertaining to ticagrelor (adequate or inadequate for each safety issue)
timeFrame: 2 months
Secondary outcomes:
measure: KAU Questionnaire: Practice characteristics
timeFrame: 2 months
measure: KAU Questionnaire: The difference in knowledge of understanding across the key safety concerns
timeFrame: 2 months
measure: KAU Questionnaire: Association between prescribers' characteristics and knowledge and understanding of the key safety concerns.
timeFrame: 2 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Research Site
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Yola Moride, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04644783: Novel Blood Test to Predict Safe Foods for Infants and Toddlers With Food Protein-induced Enterocolitis Syndrome (FPIES)
Official title: A Novel Blood Test to Predict Safe (Non-trigger) Foods for Infants and Toddlers With Food Protein-induced Enterocolitis Syndrome (FPIES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Protein-Induced Enterocolitis Syndrome
Allergies
Pediatric Disorder
Keywords: Safe foods
Trigger foods
Vomiting
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to validate a blood test that can identify safe foods for food protein-induced enterocolitis syndrome (FPIES). This study proposes a solution to the problems of FPIES by developing a new blood assay that screens a large number of foods (more than 20) in a culture plate. If this blood test is successful it may be able to identify safe foods more quickly.

The study will recruit 10 participants that will have more than 2 trigger foods.

Detailed description: Participants will complete surveys and have blood draws during the study. Additionally, participants will be asked to keep track of their diet as well as introduce safe foods identified by the researchers.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of FPIES
* Have to have documented reactions to 2-3 trigger foods with recurrent delayed vomiting or documented reactions to 4 or more trigger foods with recurrent delayed vomiting.

Exclusion Criteria:

* Patients who are currently on medications that suppress the immune system
* Patients who do not have at least 2 trigger foods identified.
* Patients who have a history of an organic Gastrointestinal (GI) disease (e.g., inflammatory bowel disease, celiac disease, biliary disorders, bowel resection), cardiac, pulmonary, neurologic, renal, endocrine, or gynecological pathology
* Lack of parental or guardian informed consent.

Primary outcomes:
measure: Negative Predictive Value (NPV), Defined as the Percentage of Test-predicted Safe Foods That Are Actually Safe Foods.
timeFrame: Up to 7 weeks from the first blood trial, on average 11 weeks
Secondary outcomes:
measure: Positive Predictive Value (PPV), Defined as the Percentage of Test-predicted Unsafe Foods That Are Actually Unsafe Foods.
timeFrame: Up to 7 weeks from the first blood trial, on average 11 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Mohamad El Zaatari, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04418583: Quantifying the Effect of the Crane Technique Through Three-dimensional Imaging
Official title: Quantifying the Effect of the Crane Technique Through Three-dimensional Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pectus Excavatum
Funnel Chest
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
First posted: 2020-06-05
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective case-control study wherein participants are their own control
Primary purpose: BASIC_SCIENCE

Brief summary: Pectus excavatum is the most common congenital abnormality of the thoracic wall and occurs in 1 in 400 newborns. The gold standard treatment is the Nuss bar Procedure. However, in very severe cases, pectus exacavatum involves little or no space between the heart and sternum. Because of the limited space, the Nuss procedure is more difficult to perform and there is an increased risk of complications such as injuries to the heart or large vessels. However, this increased risk can again be reduced by using the Crane technique. This technique increases the substernal space by sternal 'hoisting' via an external steel wire. Despite the fact that this technique is commonly used, it is not known what its quantitative effect is on the substernal space during the Nuss bar procedure. The subsequent aim of this study is to quantify the effect of the Crane technique during minimally invasive repair of pectus excavatum through three-dimensional scans acquired before and after application of the Crane technique.


Eligibility criteria: Inclusion Criteria:

* Undergoing minimally invasive repair of pectus excavatum (through the Nuss bar procedure) in conjunction with the Crane technique.

Exclusion Criteria:

* None

Primary outcomes:
measure: Mean change in chest wall dimensions
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Zuyderland Medical Centre
state: Limburg
Study officials:
References:
Clinical trial NCT04595383: Electronic Platform for Diabetic Patients Activation
Official title: Efficacy of an Electronic Communication Platform to Activate Diabetic Patients Treated With Insulin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoglycemia
Hypoglycemia Acute
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the efficacy of an electronic platform for doctor-patient communication in order to reduce severe and non-severe hypoglycemia events as well as inadvertent hypoglycemia events.

Detailed description: This is an open randomized clinical trial without drugs. Patients with type 2 diabetes and treated with insulin will be included. Patients allocated in the intervention group will use the electronic platform as a communication channel with their health provider during the time between visits.

The name of the platform is ti.care (https://ti.care/es) and it will be a complement of the control visits to resolve doubts through chats, email or video call. Health providers will answer the patient requests.

Eligibility criteria: Inclusion Criteria:

* Aged over 17 years
* Patients with type 2 diabetes diagnosis
* Patients who start insulin treatment or with intensification of treatment
* Patients who sign informed consent

Exclusion Criteria:

* Patients with type 1 diabetes diagnosis
* Life expectancy less than one year
* Pregnancy
* Patients with dementia
* Patients with treatment different to insulin
* Patients who, in the opinion of the researcher, cannot follow the recommendations of the self-care health education plan.

Primary outcomes:
measure: Change from HbA1c level at 3 months
timeFrame: Baseline and at 3 months
measure: Change from basal capillary blood glucose at 3 months
timeFrame: Baseline and at 3 months
measure: Change from postprandial blood glucose at 3 months
timeFrame: Baseline and at 3 months
measure: Change from nocturnal blood glucose at 3 months
timeFrame: Baseline and at 3 months
measure: Total hypoglycemia
timeFrame: At 3 months
measure: Number of nocturnal hypoglycemia events
timeFrame: At 3 months
measure: Number of inadvertent hypoglycemia events
timeFrame: At 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01670383: Repository for Sepsis and Postresuscitation Samples
Official title: Repository for Samples Collected From Sepsis and Postresuscitation Patients in Emergency Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Arrest
Sepsis
Keywords: Cardiac Arrest
Sepsis
Biological Markers
Anti-Inflammation Agents
Antioxidants
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-08-22
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sepsis patients admitted to ICU Postresuscitation patients admitted to ICU

Brief summary: The objective of this study is to find a new therapeutic strategy by investigating the serial serum samples of patients with sepsis or postresuscitation state.


Eligibility criteria: Inclusion Criteria:

* Age over 16 years old
* Admitted to ICU
* Diagnosed as having sepsis or as postresuscitation status
* Definition of sepsis: 2 or more SIRS criteria + infection is suspected
* Definition of postresuscitation status: Survived from non-traumatic cardiac arrest

Exclusion Criteria:

* refusal to participate
* DNAR status

Primary outcomes:
measure: 1-month mortality
timeFrame: 1 month
Secondary outcomes:
measure: Hospital mortality
timeFrame: until hospital discharge, an expected average of 2 weeks
measure: ICU length of stay
timeFrame: Until ward transfer or discharge, an expected average of 7 days
measure: Favorable neurologic outcome
timeFrame: at discharge, an expected average of 2 weeks and at 6-month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Gil Joon Suh, Professor
role: STUDY_DIRECTOR
References:
citation: Angus DC, Linde-Zwirble WT, Lidicker J, Clermont G, Carcillo J, Pinsky MR. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10. doi: 10.1097/00003246-200107000-00002.
citation: Dombrovskiy VY, Martin AA, Sunderram J, Paz HL. Rapid increase in hospitalization and mortality rates for severe sepsis in the United States: a trend analysis from 1993 to 2003. Crit Care Med. 2007 May;35(5):1244-50. doi: 10.1097/01.CCM.0000261890.41311.E9.
citation: Cohen J. The immunopathogenesis of sepsis. Nature. 2002 Dec 19-26;420(6917):885-91. doi: 10.1038/nature01326.
citation: Schneider A, Bottiger BW, Popp E. Cerebral resuscitation after cardiocirculatory arrest. Anesth Analg. 2009 Mar;108(3):971-9. doi: 10.1213/ane.0b013e318193ca99.
Clinical trial NCT04687397: Behavioral Signs of Consciousness Recovery in Patients With Disorders of Consciousness (DOCSIGNS)
Official title: Investigation of the Behavioral Signs of Consciousness Recovery in Patients With Disorders of Consciousness (DOCSIGNS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Consciousness Disorder
Brain Injuries
Lead sponsor: Hospitales Nisa
Sponsor class: OTHER
Collaborators: name: Universitat Politècnica de València
First posted: 2020-12-29
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants were subjects who were diagnosed as with UWS or in a MCS after a brain injury

Brief summary: Precise description of behavioral signs denoting transition from unresponsive wakefulness syndrome/vegetative state (UWS/VS) to minimally conscious state (MCS) or emergence from MCS after severe brain injury is crucial for prognostic purposes. A few studies have attempted this goal but involved either non-standardized instruments, limited temporal accuracy or samples, or focused on (sub)acute patients. The objective of this study is to describe the behavioral signs that led to a change of diagnosis, as well as the factors influencing this transition, in a large sample of patients with chronic disorders of consciousness after severe brain injury.


Eligibility criteria: Inclusion Criteria:

* documented medical diagnosis of CRS-R-based diagnosis of UWS or MCS at admission to the neurorehabilitation program

Exclusion Criteria:

* none

Primary outcomes:
measure: Change from baseline score in the Coma Recovery Scale-Revised until study completion
timeFrame: From inclusion in the study until discharge or death, assessed up to 24 months
Secondary outcomes:
measure: Change from baseline score in the Functional Independence Measure until study completion
timeFrame: From inclusion in the study until discharge or death, assessed up to 24 months
measure: Change from baseline score in the Disability Rating Scale until study completion
timeFrame: rom inclusion in the study until discharge or death, assessed up to 24 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Servicio de Neurorrehabilitación y Daño Cerebral de los Hospitales NISA
Study officials:
affiliation: Hospitales Nisa
name: Enrique Noé
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03952897: Quality of Life Related to Health in Spa Users
Official title: Observational Study for the Assessment of Quality of Life Related to Health in Users of the Spa of Fitero (Navarra).
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Hip Osteoarthritis
Rheumatoid Arthritis
Keywords: knee osteoarthritis
rheumatoid arthritis
balneology
hip balneology
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 80
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Users of Fitero spa

Brief summary: Hypothesis: The spa therapy treatment could improve health-related quality of life (HRQOL) in subjects with knee and/or hip osteoarthritis, and patients with rheumatoid arthritis.

Main objective: Analyze if HRQOL in patients with knee and/or hip osteoarthritis, and patients with rheumatoid arthritis is modified by spa therapy treatment in the spa of Fitero (Spain).

Design: Prospective observational study Participants: Fitero's spa users aged between 45-80 years old, diagnosed with knee and/or hip osteoarthritis, and also with rheumatoid arthritis. At least 40 patients of each type will be included in the study. Participants must be receiving a treatment of at least ten days.

Main Variable: The scores obtained in the Euroqol5Dimensions-5Levels questionnaire (EQ-5D-5L) (for all subjects), the Western Ontario MacMaster Universities Osteoarthritis Index (WOMAC) questionnaire, for subjects with knee and/or hip osteoarthritis, and the Health Assessment Questionnaire (HAQ), for subjects with rheumatoid arthritis.

Other variables: sociodemographic, anthropometric, clinics, and related with spa treatment.

Follow-up duration: 9 months.


Eligibility criteria: Inclusion Criteria:

* diagnosed arthrosis of knee or hip and/or rheumatoid arthrosis
* balneotherapy treatment of at least 10 days.
* physically and mentally able to complete questionnaires

Exclusion Criteria:

* have followed a balneotherapy treatment in the six previous month

Primary outcomes:
measure: HAQ (Health Assessment Questionnaire)-Disability of rheumatic patients
timeFrame: From 1st March 2019 to 1st December 2019
measure: WOMAC
timeFrame: From 1st March 2019 to 1st December 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Universidad de Castilla-La Mancha
Study officials:
affiliation: University of Castilla-La Mancha
name: Inés Martínez-Galán, MD
role: PRINCIPAL_INVESTIGATOR
References: