louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02977481: Ear Temperature as Predictor of Rectal Temperature Measured With Modern Devices in the Emergency Department.
Official title: Ear Temperature, Measured With 3. Generation Tympanic Thermometers as Predictor of Rectal Temperature in the Emergency Department Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fever
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 600 adult patients admitted to emergency department

Brief summary: Ear thermometers are often requested to be used rather than rectal thermometer (gold standard) for measuring the body temperature, as this method is faster and more user friendly. Former ear thermometers did not meet the required standards of accuracy for clinical use. However, a new generation of ear thermometers have been developed and widely used in the Emergency departments in Denmark. The devices have only been evaluated in two studies on adult populations, with conflicting results.

This cross-sectional study will examine patients by measuring both ear and rectal temperature in the same patient at the same time on admission to an emergency department, to evaluate if temperature measured in the ear can be used as the standard temperature measurement.


Eligibility criteria: Inclusion Criteria:

* admission to emergency department

Exclusion Criteria:

* no rectum

Primary outcomes:
measure: The Body Temperature in Celcius degrees
timeFrame: Up to 24 hours after arrival to Emergency Department
Secondary outcomes:
Other outcomes:
Locations:
city: Aabenraa
country: Denmark
facility: Aabenraa Sygehus Emergency Department
Study officials:
References:
citation: Mogensen CB, Vilhelmsen MB, Jepsen J, Boye LK, Persson MH, Skyum F. Ear measurement of temperature is only useful for screening for fever in an adult emergency department. BMC Emerg Med. 2018 Dec 3;18(1):51. doi: 10.1186/s12873-018-0202-5.
Clinical trial NCT04619381: Causes of Health Disparities in African Americans With Coronary Artery Disease on Clopidogrel
Official title: Investigation of the Causes of Health Disparities in African Americans With Coronary Artery Disease on Clopidogrel
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Coronary Artery Disease
Keywords: African American
Coronary Artery Disease
Anti Platelet
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participant population will be recruited from routine care clinic/physician visits

Brief summary: African Americans with coronary artery disease who have been prescribed clopidogrel (also known as Plavix), an antiplatelet drug will be enrolled. The purpose of this study is to help identify why African Americans are at an increased risk of having a major heart attack or stroke after a common procedure to open up blocked arteries with stents. The knowledge to be gained from this study includes:

1. A better understanding of the metabolism of the antiplatelet drug, clopidogrel, and abnormal platelet function in African Americans; this understanding may provide a basis for potential future therapy
2. A better understanding of challenges to taking clopidogrel as prescribed by a doctor and opinions about a genetic test related to this medicine.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Sex: Male and Female
3. Race: Self-identified as African American
4. History of percutaneous coronary intervention in the past 12 months
5. Currently taking aspirin and clopidogrel for at least one month and up to one year
6. English speaking

Exclusion Criteria:

1. Use of nonsteroidal anti-inflammatory drugs
2. Pregnancy will be excluded in women of child-bearing potential using urine pregnancy test

Primary outcomes:
measure: Participant Adherence to Plavix as Measured by Clopidogrel Metabolites in Plasma
timeFrame: baseline
measure: Clopidogrel resistance
timeFrame: baseline
measure: Platelet function
timeFrame: baseline
measure: Patient-level barriers to implementation of routine pharmacogenomic testing for antiplatelet therapy
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: VUMC
name: Aaron Aday, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06012981: Psychological Treatment in Psychiatric Inpatient Care
Official title: Psychological Treatment in Psychiatric Inpatient Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Compulsory Psychiatric Care Act
Psychosis
Acceptance & Commitment Therapy
Psychiatric Hospitalization
Psychiatric Disorder
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-case experimental design.
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effect of a brief psychotherapeutic treatment intervention based on ACT, aimed specifically at the vulnerable group of patients in psychiatric 24-hour care treated according to LPT. The study aims to investigate whether a brief number of therapeutic sessions according to ACT during inpatient care produce positive effects on personally relevant life areas for a diagnostically mixed group of patients in a psychiatric intensive care unit.


Eligibility criteria: Inclusion Criteria:

* 18 years old or older.
* Treated according to the compulsory psychiatric care act.
* Meet the criterion of informed consent.

Exclusion Criteria:

* Lack the cognitive ability to acquire the treatment intervention, such as impaired attention, memory, logic and reasoning, and also auditory and visual processing. This will be based on a clinical assessment by the ward team, including the attending psychiatrist and a clinical psychologist.
* Ongoing psychological treatment parallel to the admission.

Primary outcomes:
measure: Change in Personal Questionnaire
timeFrame: Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session
measure: Change in Bull's Eye Values Survey
timeFrame: Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session
measure: Change in PHQ-9
timeFrame: Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session
measure: Change in GAD-7
timeFrame: Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session
measure: Change in Psy-flex
timeFrame: Four times daily, from point of inclusion to after a minimum of five data points (approximately a day and a half) after last treatment session
Secondary outcomes:
Other outcomes:
Locations:
city: Västerås
country: Sweden
facility: Hospital of Västmanland, Västerås
state: Västmanland
Study officials:
affiliation: Uppsala University
name: Kent Nilsson, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04879095: Urdu Translation, Validity and Reliability of Dyspnea 12 (D-12)
Official title: Urdu Translation, Validity and Reliability of Dyspnea 12 (D-12)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: Body mass index (BMI)
Rate of perceived exertion (RPE)
6 minute walk test (^MWT)
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD

Brief summary: Dyspnea is a distressing symptom with pain like perception. The object of study is to translate a tool that measure overall dyspnea severity. Although many scales are available to assess dyspnea but D12 is a clear reliable scale and is use full in clinical practice to assess dyspnea in terms of intensity, quality and emotional response.

Detailed description: Aim of study is to translate a clinical validate of Urdu version of D-12 in COPDs patients. The study will measure reliability \& validity of dyspnea in Urdu version. No study has been conducted in our region to translate D-12 follow the proper cross culture adaptation. Therefor the instrument will translate in our language adapting proper cross culture guidelines.

Eligibility criteria: Inclusion Criteria:

* Patient age between 40-65 with diagnosis of COPD
* Outpatient individual who are on follow up
* Healthy individual
* Those who can read and understand English and Urdu as well.

Exclusion Criteria:

* Patient with cognitive impairment or sensory disorder were exclude.
* Patient physical disability
* Refuse to perform test

Primary outcomes:
measure: Translation of Dyspnea 12 in Urdu version
timeFrame: 4 Week
Secondary outcomes:
measure: Six minute Walk test
timeFrame: 4 week
measure: Rate Perceived Exertion
timeFrame: 4 week
Other outcomes:
Locations:
city: Hyderabad
country: Pakistan
facility: Civil Hospital
state: Sindh
Study officials:
affiliation: Riphah International University
name: sumaiyah Obaid, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01330095: Early Administration of Bifidobacterium to Very Low Birth Weight Infants
Official title: Early Administration of Bifidobacterium Bifidum to Very Low Birth Weight Infants: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infants
Keywords: Bifidobacterium bifidum
Very low birth weight infant
Enteral feeding
Growth
amount of enteral feeding
Lead sponsor: Tokyo Women's Medical University
Sponsor class: OTHER
First posted: 2011-04-06
Enrollment: 36
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the effects of early administration of probiotics on acceleration of enteral feeding, and on growth of very low birth weight infants, newborn infants with birth weight less than 1500g are administered Bifidobacterium bifidum twice a day.


Eligibility criteria: Inclusion Criteria:

* Very low birth weight infant

Exclusion Criteria:

* Presence of major congenital malformations

Primary outcomes:
measure: the day at total feeding volume reached 100ml/kg/day
timeFrame: post natal day
Secondary outcomes:
measure: colonizatin of Bifidobacterium
timeFrame: 4 weeks after birth
Other outcomes:
Locations:
city: Shinjuku
country: Japan
facility: Tokyo Women's Medical Unversity
state: Tokyo
Study officials:
References:
citation: Yamasaki C, Totsu S, Uchiyama A, Nakanishi H, Masumoto K, Washio Y, Shuri K, Ishida S, Imai K, Kusuda S. Effect of Bifidobacterium administration on very-low-birthweight infants. Pediatr Int. 2012 Oct;54(5):651-6. doi: 10.1111/j.1442-200X.2012.03649.x. Epub 2012 Jul 10.
Clinical trial NCT04889495: A Post-marketing Surveillance to Assess the Safety and Effectiveness of Zirabev in Domestic Patients With Various Cancer
Official title: A Prospective, Single-arm, Open-label, Non-interventional, Multicenter, Post-marketing Surveillance to Assess the Safety and Effectiveness of Zirabev in Domestic Patients With Non-small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Breast Cancer, Advanced or Metastatic Kidney Cancer, Cervical Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer or Glioblastoma Multiforme.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Non-small Cell Lung Cancer
Metastatic Colorectal Cancer
Metastatic Breast Cancer
Metastatic Kidney Cancer
Cervical Cancer
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Primary Peritoneal Cancer
Keywords: Zirabev
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-05-17
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: See below

Brief summary: This is a prospective, single-arm, open-label, non-interventional, multicenter, post-marketing surveillance to assess the safety and effectiveness of Zirabev(Bevacizumab biosimilar) in domestic patients with non-small cell lung cancer, metastatic colorectal cancer, metastatic breast cancer, advanced or metastatic kidney cancer, cervical cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or glioblastoma multiforme.


Eligibility criteria: - Inclusion criteria

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. Adults over 19 years old
2. Patients with non-small cell lung cancer, metastatic colorectal cancer, metastatic breast cancer, advanced or metastatic kidney cancer, cervical cancer, epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer or glioblastoma multiforme.
3. Patients eligible for Zirabev dosage based on local product document, local treatment guidelines and clinical judgment of the medical team.
4. Evidence of a signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

   * Exclusion criteria

Patients meeting any of the following criteria will not be included in the study:

1. Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information.
2. Patients for whom Zirabev is contraindicated according to the local product document.

Primary outcomes:
measure: Safety profile
timeFrame: baseline up to approximately 4 years
Secondary outcomes:
measure: Efficacy profile
timeFrame: baseline up to approximately 4 years
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03536195: Impact of Renal Replacement Therapy on Coagulation Profile of Patients with Acute Renal Failure
Official title: Impact of Renal Replacement Therapy on Coagulation Profile in Patients with Acute Renal Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Renal Failure
Hemorrhage
Coagulation Disorder
Keywords: renal replacement therapy
acute renal failure
coagulation
bleeding
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients with acute renal failure where the decision of renal replacement therapy has been made.

Brief summary: Renal failure and high plasmatic level of urea have been associated with an increased risk of hemorrhage in surgical patients. There is only sparse data on the impact of renal replacement therapy on homeostatic parameters. The aim of this study is to describe potential changes in homeostatic parameters before and after renal replacement therapy.


Eligibility criteria: Inclusion Criteria:

* critically ill patients
* acute renal failure
* renal replacement therapy
* plasmatic urea \> 20

Exclusion Criteria:

* chronic renal failure
* platelet count less than 80 Giga
* V factor less than 70%

Primary outcomes:
measure: visco elastometry
timeFrame: Change in ROTEM parameters from baseline to after renal replacement therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT01648595: Effect of Fentanyl on Pain Severity and Duration of Labor
Official title: Principal Investigator
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Decrease Labor Pain
Keywords: Fentanyl
analgesia
duration of the active phase
pain severity
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 70
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 37
Standard ages: ADULT
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: There are two methods of pharmacologic and non- pharmacologic for reducing pain of delivery. It is necessary to be known effect of these drugs on the mother and fetus during labor adverse. Therefore, the purpose of this study was determination of effect of Fentanyl intravenously on pain severity during the active phase of labor.


Eligibility criteria: Inclusion Criteria:

* multiparas pregnant women (gravid 2-7),
* term singleton pregnancy,
* cephalic presentation,
* low risk pregnancy with no history of drug tolerance (addiction),
* medical and mental diseases.

Exclusion Criteria:

* Respiratory rate ≤ 8 or maternal bradycardia (pulse rate less than 60).

Primary outcomes:
measure: decrease pain and duration of the active phase considerably.
timeFrame: up to 8 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02298881: Ocular Surface Microbiome
Official title: Diversity and Dynamic Stability of the Ocular Surface Microbiome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dry Eye Syndromes
Keywords: Dry Eye
Microbiome
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Eye Institute (NEI)
First posted: 2014-11-24
Enrollment: 80
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: Adult patients from the investigators' practices at the University of Washington Eye Institute

Brief summary: The purpose of this study is to collect samples from the surface of eyelids to try to grow and identify bacteria or fungus that might be present, and to try to understand why people have dry eye symptoms.

Detailed description: "Dry eye" is a very common eye condition, which may or may not be caused by specific microorganisms that live on the surface of the eye. In this study, a combination of tissue culture and molecular biology techniques will be used to identify every microbe (bacteria, fungus, or virus) on the surface of eyes of people with dry eye syndrome, as well as a 'control' group of people who don't have dry eye disease.

Eligibility criteria: Inclusion Criteria:

* Subjects with ocular surface discomfort with an Ocular Surface Disease Index score of greater than 60
* Subjects with and Ocular Surface disease Index score less than 30
* Males and females age 18 or older

Exclusion Criteria:

* Contact lens wear
* Use of oral or topical antibiotics in past 6 months
* Use of prescription eye medication in past 6 months
* Penetrating ocular or keratoplasty surgery in last 12 months
* Children under the age of 18

Primary outcomes:
measure: To catalog the bacteria and other micro-organisms that are naturally found on the eye surface.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: UW Medicine Eye Institute
state: Washington
Study officials:
affiliation: UW Medicine Eye Institute
name: Russell N VanGelder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Doan T, Akileswaran L, Andersen D, Johnson B, Ko N, Shrestha A, Shestopalov V, Lee CS, Lee AY, Van Gelder RN. Paucibacterial Microbiome and Resident DNA Virome of the Healthy Conjunctiva. Invest Ophthalmol Vis Sci. 2016 Oct 1;57(13):5116-5126. doi: 10.1167/iovs.16-19803.
Clinical trial NCT04785781: Effects of Face Masks on Cardiopulmonary Capacity in Healthy Individuals
Official title: Effects of Face Masks on Cardiopulmonary Capacity in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid-19
Keywords: covid19
cardiopulmoary
exercise capacity
face masks
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2021-03-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: individuals will perform cycle ergometer without mask, with surgical mask and FFP2/N95. there will be 48 hours wash-out between tests.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of our study is to compare the effects of face masks on cardiopulmonary capacity in young healthy individuals. The results of our study will show the effects of face masks commonly used during the pandemic period.

Detailed description: The aim of our study is to compare the effects of face masks on cardiopulmonary capacity in young healthy individuals. The results of our study will show the effects of face masks commonly used during the pandemic period.

The hypotheses we will test for this purpose; H1: face masks affect cardiopulmory capacity in healthy individuals H2: face masks affect heart rate in health individuals H3: face masks affect oxygen saturation in healthy individuals H4: face masks affect respiratory frequency in healthy individuals

Eligibility criteria: Inclusion Criteria:

* 18 years old to 30
* healthy young individuals

Exclusion Criteria:

* having cardiovasculary conditions
* having respiratory conditions
* having inflammatory conditions
* any contraindicated situations for cardiopulmonary tests

Primary outcomes:
measure: time to exhaustion
timeFrame: 5-10 minutes
measure: Mask comfort/discomfort
timeFrame: 5-10 minutes
Secondary outcomes:
measure: heart rate
timeFrame: 1 minute
measure: oxygen saturation
timeFrame: 1 minute
measure: respiratory frequency
timeFrame: 1 minute
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Fatma Ünver
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05375981: MAGNET Ingestion in Children
Official title: Magnet Ingestion in Children: a Prospective Surveillance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Foreign Bodies
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 366
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Definite magnetic foreign body ingestion in children \<16yrs

Brief summary: One year national observational surveillance study of children who ingest a magnetic foreign body

Detailed description: The study aims to understand the incidence, management and outcomes of children who ingest a magnetic foreign body.

Eligibility criteria: Inclusion Criteria:

* Magnetic foreign body ingestion
* 16 years of age or less

Exclusion Criteria:

* Non ingested foreign body

Primary outcomes:
measure: Incidence of MAGNETIC Foreign Body Ingestion
timeFrame: Over 1 year from May 1st 2022
Secondary outcomes:
measure: Investigations and management of magnetic foreign body ingestion
timeFrame: Up to 28 days following ingestion
measure: Outcomes of magnetic foreign body ingestion
timeFrame: Up to 28 days following ingestion
Other outcomes:
Locations:
city: Southampton
country: United Kingdom
facility: Southampton Children's Hospital
Study officials:
References: