louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02805322: Comparison of a Novel Non-Invasive, Non-Touch Infrared Thermometer With Routine Thermometry in Routine Clinical Practice
Official title: Comparison of a Novel Non-Invasive, Non-Touch Infrared Thermometer With Routine Thermometry in Routine Clinical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Febrile
Lead sponsor: ARC Devices
Sponsor class: INDUSTRY
Collaborators: name: Cork University Hospital
First posted: 2016-06-20
Enrollment: 138
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Quantify the reliability and agreement of estimated core body temperature using the InstaTemp MD™ and other widely marketed reference Thermometers

Detailed description: This is a cross sectional Clinical Investigation in order to quantify the reliability and agreement of estimated core body temperature using emitted surface body heat measured by the InstaTemp MD™ Non-Touch thermometer when compared to other widely marketed reference Thermometers

Eligibility criteria: Inclusion Criteria:

1. Any age
2. Either gender
3. Attending ED, outpatients or inpatient Departments of Cork University Hospital Campus
4. Provision of informed consent or in case of minor's provision of age appropriate assent with informed consent of parent (legal guardian).

Exclusion Criteria:

1. Those who in the opinion of the researcher are too agitated, distressed or who are otherwise unable to cooperate with study procedures
2. Those who forehead cannot be fully exposed to the ambient conditions for at least 15 minutes
3. Those with signs or recent history of inflammation or infection of the forehead or at the Reference Clinical Test site
4. Subjects currently using cooling blankets or fans.
5. Subjects currently receiving treatment with thyroxine, barbiturates, antipsychotics, corticosteroids, alcoholic intoxication, documented illicit drug use or immunizations In the previous 5 days
6. Any recent hot or cold drinks prior to a sub-lingual reading (i.e. 15min before measurement)
7. Those participating in a clinical trial of an investigational medicinal product

Primary outcomes:
measure: Mean Bias
timeFrame: Baseline temperature measurement using all relevant interventions
measure: Reproducibility
timeFrame: Baseline measurement of 3 temperature reading
Secondary outcomes:
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Hospital
state: Munster
Study officials:
affiliation: Cork University Hospital, Ireland
name: Joe Eustace, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03233022: An Online Trial of Five Well-being Programs
Official title: A Randomized Trial Examining the Impact of Five 8-week Online Well-being Programs on Mood and Well-being
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Well-being
Lead sponsor: Happify Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-28
Enrollment: 14000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Users are randomly assigned between arms after completing baseline assessment and stay in that arm for the duration of the study.
Primary purpose: OTHER

Brief summary: Participants complete an 8-week program and complete assessment measures to track their outcomes over time.

Detailed description: Participants will be randomly assigned between five different well-being programs, each 8-weeks long and taking place on a simplified research version of the Happify platform. They will be asked to complete questionnaires before and after the 8-week program, as well as 1-month, 3-month, and 6-month follow-up questionnaires after the program is complete, at which point study participation will end.

Eligibility criteria: Inclusion Criteria:

* No prior experience on the Happify platform (new user registration)

Exclusion Criteria:

* None

Primary outcomes:
measure: Depressive Symptoms (Patient Health Questionnaire 9-item; PHQ-9)
timeFrame: Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up
measure: Anxiety Symptoms (Generalized Anxiety Disorder 7-item; GAD-7)
timeFrame: Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up
Secondary outcomes:
measure: Resilience composite
timeFrame: Change from baseline to 8-week post, 1-month, 3-month, and 6-month follow-up
Other outcomes:
Locations:
city: New York
country: United States
facility: Happify (an online platform -- study is entirely online)
state: New York
Study officials:
References:
citation: Carpenter J, Crutchley P, Zilca RD, Schwartz HA, Smith LK, Cobb AM, Parks AC. Seeing the "Big" Picture: Big Data Methods for Exploring Relationships Between Usage, Language, and Outcome in Internet Intervention Data. J Med Internet Res. 2016 Aug 31;18(8):e241. doi: 10.2196/jmir.5725.
Clinical trial NCT00851422: Accurate Measurement of Cardiac Output Using the Ultrasound Dilution Technique
Official title: Accurate Measurement of Cardiac Output Using the Ultrasound Dilution Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Output
Keywords: Ultrasound Dilution
Cardiac Output
Validation of measured ultrasound dilution cardiac output
Lead sponsor: Transonic Systems Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-02-26
Enrollment: 28
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any pediatric patient (aged \< 18 years) who has undergone cardiac transplantation and is already scheduled for a biopsy will be offered the opportunity to participate.

Brief summary: Accurate cardiac output determination is a commonly used and important index of myocardial performance. The thermodilution method using a pulmonary artery catheter is the most common approach to cardiac output determination; however, placement of the pulmonary artery catheter is not without risk and at times can be problematic. Ultrasound dilution measurement has been shown to correlate with measured cardiac output in animal models and adults, but it has not been validated in pediatric patients. This study will validate the accuracy of ultrasound dilution measurements of cardiac output to thermodilution measurements of cardiac output in pediatric patients.


Eligibility criteria: Inclusion Criteria:

* Transplant patients undergoing hemodynamic evaluation in the catheterization laboratory that are less than 18 years of age and have structurally normal hearts.

Exclusion Criteria:

* Patient's age greater than 18 years, and any structural abnormality of the heart.

Primary outcomes:
measure: Validation of cardiac output measured by ultrasound dilution with cardiac output measured by thermodilution.
timeFrame: 5-8 minutes minimum
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Texas Children's Hospital, Baylor College of Medicine
name: Jeffery J Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc.
citation: Crittendon I 3rd, Dreyer WJ, Decker JA, Kim JJ. Ultrasound dilution: an accurate means of determining cardiac output in children. Pediatr Crit Care Med. 2012 Jan;13(1):42-6. doi: 10.1097/PCC.0b013e3182196804.
Clinical trial NCT00623025: Creon in HIV Patients With Steatorrhea
Official title: Double-blind, Cross-over, Randomized, Placebo-controlled, Multi-center Study to Investigate the Effect of Creon®25 000 on the Coefficient of Fat Absorption of HIV-infected Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Steatorrhea
Keywords: HIV
Steatorrhea
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-02-25
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study investigates the effect of pancreatic enzymes on steatorrhea in HIV patients.


Eligibility criteria: Inclusion Criteria HIV positive patients with clinically stable disease (Karnofsky Performance Status \> 40);

* Steatocrit \> 2 %;
* Females of child-bearing potential must have a negative pregnancy test during prestudy or the subject must be surgically sterile or be at least 1 year postmenopausal as judged by the investigator;
* Women of child-bearing potential must be using a medically acceptable method of birth control throughout the study

Exclusion Criteria

* Known allergy to pancreatin or any history of abnormal drug reaction;
* Known diagnosis of pancreatic exocrine insufficiency due to e.g. chronic pancreatitis or cystic fibrosis or pancreatectomy;
* Intake of an experimental drug within four weeks prior to entry into the study;
* Alcohol abuse within the last six months;
* Suspected non-compliance or non-cooperation;
* Any other lack of fitness, in the investigator's opinion, to participate in or to complete the study;
* Patients with a stool fat excretion \<= 7 g/day according to van de Kamer during the run-in period

Primary outcomes:
measure: Coefficient of fat absorption (CFA)
timeFrame: After 2 weeks
Secondary outcomes:
measure: Stool fat excretion
timeFrame: After 2 weeks
measure: Normalization (yes, no) of stool fat excretion, i.e. < 7 g/day
timeFrame: After 2 weeks
measure: Response (yes, no) with respect to stool fat excretion, i.e. improvement in stool fat excretion as compared to baseline
timeFrame: After 2 weeks
measure: Stool weight
timeFrame: After 2 weeks
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Site Reference ID/Investigator# 59364
city: Craiova
country: Romania
facility: Site Reference ID/Investigator# 59363
Study officials:
affiliation: Abbott
name: Suntje Sander, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04593225: Effectiveness of VIRTUAL SFCAMINA STUDY
Official title: Effectiveness of Virtual Multicomponent Treatment for Chronic Fatigue Syndrome: VIRTUAL SFCAMINA STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Fatigue Syndrome
Keywords: multicomponent treatment
Chronic Fatigue Syndrome
pain neuroscience education
therapeutic exercise
cognitive behavioural therapy
mindfulness
randomized controlled trial
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment Single-blind, parallel-group, randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to analyse the effectiveness of the VIRTUAL SFCAMINA multicomponent treatment program as coadjuvant of treatmentas- usual (TAU) compared to TAU alone. In this Randomized Controlled Trial (RCT), in addition to evaluating the clinical effects of VIRTUAL SFCAMINA treatment in the short- and long term.

Detailed description: This is a tree-arm RCT focused on the safety and potential effectiveness of the multicomponent program VIRTUAL SFCAMINA as coadjuvant of treatmentas- usual (TAU) vs. TAU alone.

* VIRTUAL SFCAMINA combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.
* The main hypothesis is that improvement on fatigue of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as kinesiophobia, fear avoidance and by individualized therapeutic exercise.

Eligibility criteria: Inclusion Criteria:

* Meet the Fukuda and Holmes classification criteria for Fatigue Syndrome Chronicle
* Age equal to or greater than 18 years
* Understand and agree to participate in the study
* Sign the informed consent

Exclusion Criteria:

* Terminal clinical conditions or scheduled treatments that may interrupt the study follow-up.

Primary outcomes:
measure: Multidimensional Fatigue Inventory (MFI)
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Tampa Scale for Kinesiophobia (TSK-11)
timeFrame: Through study completion, an average of 3 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Through study completion, an average of 3 months
measure: Physical Function of the 36-Item Short Form Survey (SF-36)
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebrón Hospital
city: Barcelona
country: Spain
facility: Vall d'Hebrón Hospital
Study officials:
affiliation: Vall d'Hebrón Hospital
name: Mayte Serrat, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03126825: CLEAR Clinical Study
Official title: Clinical Evaluation of the SpatialNR Noise Reduction Algorithm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2017-04-24
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute in-booth assessment of a new noise reduction algorithm with cochlear implant recipients.


Eligibility criteria: Inclusion Criteria:

1. Conventional CI subject aged twelve years of age or older, or Hybrid subject aged 18 years or older
2. Recipient of a CI500 Series (CI512 or CI522) or CI24RE Series (CI24REH or CI422) cochlear implant
3. At least three months CI experience in ear to be assessed
4. At least three months experience with the CP810,CP920 or CP910 sound processor
5. Fluent speaker in the local language used to assess clinical performance
6. Open-set speech perception ability
7. Use of or eligibility for hybrid acoustic component (hybrid population only)

Exclusion Criteria:

1. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the investigational device
2. Unwillingness or inability of the candidate to comply with all investigational requirements
3. Additional handicaps that would prevent or restrict participation in the audiological evaluations or that would affect the scientific integrity of the study.

Primary outcomes:
measure: CNC words
timeFrame: 3 months
measure: SRT sentences
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Cochlear Limited Sydney
state: New South Wales
city: Melbourne
country: Australia
facility: Cochlear Limited Melbourne
state: Victoria
Study officials:
affiliation: Head of Global Clinical Affairs
name: Mary Beth Brinson, Phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT04961125: Multicenter Study on the Pathogenic Germline Gene Variants of Colorectal Polyposis in China
Official title: Multicenter Study on the Pathogenic Germline Gene Variants of Colorectal Polyposis in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Polyposis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients suspected of adenomatous polyposis, with more than 10 polyps observed under colonoscopy, and pathological confirmation of adenoma.

Brief summary: Patients suspected of adenomatous polyposis were included. The criteria used were more than 10 polyps observed under colonoscopy, and pathological confirmation of adenoma. Clinical data and pedigree information were collected. The variants of 139 genes associated with different hereditary cancers and polyposis were screened by NGS, which was performed by Genetron Health on the HiSeqX-ten sequencing platform.


Eligibility criteria: Inclusion Criteria:

1. clinical diagnosis of adenomatous polyposis;
2. enough samples (provide at least 5ml of peripheral whole blood) for germline variant detection

Exclusion Criteria:

genetic diagnosis of polyposis syndrome

Primary outcomes:
measure: germline variant detection rate in the polyposis population
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: General Hospital of Air Force
state: Beijing
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: SAHZU
state: Zhejinag
Study officials:
References:
Clinical trial NCT01669525: Placental Growth and Adverse Pregnancy Outcomes
Official title: Placental Growth and Maternal Serum Biomarkers in the Prediction of Adverse Pregnancy Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension Induced by Pregnancy
Pre-Eclampsia
IUGR
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2012-08-21
Enrollment: 1043
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Singleton pregnancies presenting for Sequential Screen prior to 14 weeks gestation

Brief summary: The purpose of this study to determine if measurement of maternal serum biomarkers and evaluation of the placenta by ultrasound can improve prediction of adverse pregnancy outcomes.

Detailed description: The placenta is known to play a vital role in maintaining a healthy pregnancy. Placental dysfunction is believed to be a driving factor in a variety of adverse obstetric outcomes, including fetal growth restriction and preeclampsia. Advances in 3D ultrasound have allowed for measurement of placental volumes during pregnancy. It may be that quantitative assessment of early placental growth can help identify pregnancies at risk for adverse outcome. Furthermore, various novel serum analytes have been proposed as predictors of adverse outcome. The investigators seek to prospectively measure placental volume and diameter at 11-14 weeks and 18-24 weeks to determine if placental growth can predict adverse outcome. In addition, the investigators seek to investigate the relationship between placental growth and serum levels of various biomarkers to see if improved detection of adverse outcome can be achieved.

Eligibility criteria: Inclusion Criteria:

* All singleton gestations presenting for Sequential Screen testing at HUP
* patients competent to provide verbal informed consent

Exclusion Criteria:

* Multiple gestations
* patients not competent to provide informed consent
* patients found to be too late for the Sequential Screen
* pregnancy losses 20 weeks gestation
* major fetal anomalies
* patient delivering outside of the UPHS

Primary outcomes:
measure: Small for gestational birth weight (SGA-dichotomous)
timeFrame: from 11-14 weeks in pregnancy until delivery (approximately 40 weeks)
Secondary outcomes:
measure: Includes a composite adverse outcome defined by any of the following: SGA, pre-eclampsia, or perinatal death.
timeFrame: post partum
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Nadav Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01591525: Diabetes Mellitus Community Based Screening in Minority Populations
Official title: Diabetes Mellitus Community Based Screening in Minority Populations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type II Diabetes
Diabetes Mellitus
Keywords: Type II Diabetes
Minorities
Diabetes Mellitus
Community based screening
Lead sponsor: Ethnicity and Disease Community Empowerment Center
Sponsor class: OTHER
Collaborators: name: Steward Carney Hospital
name: Boston Public Housing Authority
First posted: 2012-05-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents in Boston Public Housing

Brief summary: The purpose of the type II diabetes (T2D) screening study is to improve diabetes care in minority communities by identifying undiagnosed and uncontrolled T2D patients, as well as help patients without a regular primary care physician (PCP) find one within their community. These goals will be achieved first through a glucose measurement. Individuals with a high glucose measurement will be confirmed with a rapid hemoglobin A1c (HgA1c) test. The HgA1c test will tell us about the patients average blood sugar over the past 3 months, which will allow us to immediately diagnose new and uncontrolled type II diabetics. All participants will fill out a survey on healthcare seeking behaviors before glucose testing. All patients who enter the study will receive education on T2D and the value of regularly visiting their PCP, and will be provided a list of PCP currently accepting new patients within a 3 mile radius. Follow-up visits at 4 and 8 months will help us determine the success this community based screening.

The investigators hypothesis is that community based screening designed with adequate education and follow-up, and performed by qualified medical professionals will improve diabetes care in minority communities as assessed through hemoglobin A1c levels over 8 months, and in the change in the number patients who visit/obtain their PCP within the study period.


Eligibility criteria: Inclusion Criteria:

* Adults 18 and older

Exclusion Criteria:

* Type I Diabetes.
* Women who are currently pregnant.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Dorchester
country: United States
facility: Lower Mills
state: Massachusetts
Study officials:
affiliation: Ethnicity and Diseasse Community Empowerment Center
name: Kelly Lamb, MA
role: STUDY_DIRECTOR
affiliation: Ethnicity and Disease Community Empowerment Center
name: Jean Bonnet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Steward Carney Hospital
name: James Morgan, MD
role: PRINCIPAL_INVESTIGATOR
References: