louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02755493: Quantifying and Developing Countermeasures for the Effect of Fatigue-Related Stressors on Automation Use and Trust During Robotic Supervisory Control
Official title: Quantifying and Developing Countermeasures for the Effect of Fatigue-Related Stressors on Automation Use and Trust During Robotic Supervisory Control"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Space Biomedical Research Institute
First posted: 2016-04-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This project proposes to both develop and test adaptive automation countermeasures for the effects of stressors such as sleep deprivation (SD) on human performance related to robotic tasks, and investigate the relationship between human trust and appropriate use of these countermeasures.


Eligibility criteria: Inclusion Criteria:

* healthy by history, physical exam, laboratory evaluations of urine and blood, electrocardiogram (ECG), psychological screening, and self-reported sleep quality.
* engineering or computer programming experience

Exclusion Criteria:

* color blind
* pregnant or nursing
* using any prescription or non-prescription medications, caffeine, alcohol or tobacco for the three weeks prior to beginning the inpatient experiments

Primary outcomes:
measure: Performance metrics on simulated robotic tasks - time
timeFrame: 72 hours
measure: Performance metrics on simulated robotic tasks - number complete
timeFrame: 72 hours
measure: Performance metrics on simulated robotic tasks - resources uses
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Elizabeth B Klerman, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00273793: Increasing Contingency Management Success in Smoking Cessation
Official title: Increasing Contingency Management Success Using Shaping
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institutes of Health (NIH)
First posted: 2006-01-09
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Incentives can be used to facilitate the acquisition of many healthy behaviors, such as smoking cessation. However, there is much room for improvement in the use of incentives. This study investigates how two aspects of providing incentives influence the effectiveness of using incentives to promote smoking cessation. One aspect is the criterion for providing incentives, e.g., whether to require smoking cessation before providing an incentive or to provide incentives following smoking reductions. The other aspect being investigated is whether it is best to use a fixed incentive amount or an amount that increases with continued cessation success.


Eligibility criteria: Inclusion Criteria: Daily Smokers smoking a pack or more of cigarettes a day who are able to report to the study site each work day for about 5 minutes for around 3 months. Subjects must also have a breath CO level indicative of smoking at this level, and most report smoking for at least two years. Subjects must intend on quitting smoking.

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Exclusion Criteria: Participation in another study by this group within the past year. Inability to give informed consent. Incapable of attendance each workday during the morning hours.

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Primary outcomes:
measure: Breath Carbon Monoxide Levels Indicating Smoking Abstinence During the Study, i.e., the Number of Breath Samples With Carbon Monoxide (CO) Levels Less Than 3 Parts Per Million (Ppm)
timeFrame: daily for breath CO
Secondary outcomes:
measure: Average Number Cigarettes Reported Smoked Each Day in the Past Week Measured at Follow-up Six Months After Entry Into the Study
timeFrame: past week at follow-up six months after study entry
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Smoking Cessation Laboratory, Department of Psychiatry, UTHSCSA, 7703 Floyd Curl Drive
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Richard J Lamb, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04522193: Dumping Syndrome and Esophageal Atresia
Official title: Physiopathology of Dumping Syndrome in Esophageal Atresia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oesophageal Atresia
Dumping Syndrome
Keywords: Oesophageal dysmotility
Oesophageal atresia
Post prandial hypoglycaemia
Gastric emptying troubles
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Groupement Interrégional de Recherche Clinique et d'Innovation
name: french patient association for oesophageal atresia AFAO
First posted: 2020-08-21
Enrollment: 15
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Dumping syndrome (DS) is frequent in oesophageal atresia (29%). In causing hypoglycaemia, it can be dangerous for neonates. Mechanisms of DS are actually partialy understood. This is also an affection difficult to diagnose, because it only occurs after meals and can be inconstantly present. To date, their is only symptomatic treatment for DS. This study aims to understand its pathological mechanisms so as to better treat it and avoid its consequences. Oesophageal atresia patients enrolled in this study will benefit from a continuous glycemic monitoring, a continuous cardiac monitoring, and an a gastric emptying scintigraphy at the age of 3 months


Eligibility criteria: Inclusion Criteria:

* Patients operated at birth for Oesophageal atresia type C
* Aged from 2 to 3 months at inclusion
* Off prokinetic treatment (suspended for at least 72 hours) before monitoring

Exclusion Criteria:

* History of dumping syndrome of other cause (microgastria, fundoplication, dysautonomia..)
* History of any disease that can modify glycemic regulation (hyperinsulinism, neonatal diabete)
* Treatment that can modify gastric motility

Primary outcomes:
measure: Abnormal glycaemia associated with vagal hypertonia
timeFrame: At least once during the 48 hours monitoring
Secondary outcomes:
measure: Abnormal glycaemia associated with abnormal gastric emptying
timeFrame: At least once during the 48 hours monitoring
measure: Persistance of dumping syndrome
timeFrame: At the age of 6 months
measure: Tolerance of glucose monitoring
timeFrame: At least once during the 48 hours monitoring
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Jeanne de Flandres
Study officials:
affiliation: University Hospital, Lille
name: Madelaine AUMAR, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02366793: Accessory Joint and Neural Mobilizations in Shoulder After Breast Cancer Surgery. Randomized Clinical Trial.
Official title: Accessory Joint and Neural Mobilizations in Shoulder Range of Motion Restriction After Breast Cancer Surgery. A Pilot Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: accessory mobilization, nerve mobilization.
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2015-02-19
Enrollment: 18
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The potential consequences after breast cancer surgery are joint pain and sensitive disorders, the main sign of which is alterations in shoulder mobility. Global kinesitherapy has been shown to be effective at increasing shoulder range of motion restriction. However, literature does not consider specific manual therapy techniques, which means peripheral nerves and articular capsule have not been taken into account. These two tissues are potentially damaged structures during surgery and they are main responsible for shoulder range of motion restriction The main objective of this study is to pilot the effectiveness of accessory joint and nerve mobilization techniques in order to get an overview of the articular capsule and nerve dysfunctions involvement in shoulder motion restriction.

Detailed description: Background: The potential consequences after breast cancer surgery are joint pain and sensitive disorders, the main sign of which is alterations in shoulder mobility. Design: Prospective randomized and double-blind pilot trial. Objective: To pilot the effectiveness of accessory joint and nerve mobilization techniques in order to get an overview of the joint capsule and nerve involvement in shoulder motion restriction. Participants: 18 women who were undergoing unilateral breast cancer surgery and axillary lymph node dissection. Setting: Women´s Health Research Group at Physical Therapy Department of University of Alcala, Madrid, Spain. Intervention: accessory joint mobilization versus neural mobilization. Follow-up: Six-month follow-up. Key outcomes: Range of motion, sensitive disorder, pain and upper limb functionality.

Eligibility criteria: Inclusion Criteria:

* unilateral breast cancer diagnosis
* breast cancer with axillary lymph node dissection
* be willing to sign the informed consent form

Exclusion Criteria:

* bilateral breast cancer diagnosis
* loco-regional recurrence
* systemic disease
* had not undergone the axillary lymph node dissection approach
* to present any contraindication for Physical Therapy.

Primary outcomes:
measure: Shoulder Range of motion
timeFrame: 15 min
Secondary outcomes:
measure: Pain
timeFrame: 5 min
measure: Upper limb functionality
timeFrame: 10 min
Other outcomes:
Locations:
Study officials:
affiliation: SUPERVISOR
name: MARÍA TORRES-LACOMBA, DOCTOR
role: STUDY_DIRECTOR
References:
Clinical trial NCT05615311: Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm
Official title: Respiratory Outcomes After Early Vitamin D Supplementation in Infants Born Extremely Preterm: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Prematurity; Extreme
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-11-14
Enrollment: 126
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either the highest (intervention group) or lowest (control group) vitamin D dose recommended during the first 14 days after birth.


Eligibility criteria: Inclusion Criteria:

* Gestational age of 28 weeks or less

Exclusion Criteria:

* Major congenital anomalies and infants
* Terminal illness in whom decisions to withhold or limit life support have been made

Primary outcomes:
measure: Severity of respiratory morbidity
timeFrame: 0 - 120 days
measure: Non-invasive oscillometry (NiOS) measurements of pulmonary mechanics
timeFrame: 40 - 120 days
Secondary outcomes:
measure: Bronchopulmonary dysplasia
timeFrame: 36 weeks PMA or discharge
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT01498211: Normative Data of Intra-epidermal Nerve Fiber Density
Official title: Establishement of Normative Intra-epidermal Nerve Fiber Density Using Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: volunteer
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2011-12-23
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Intra-epidermal nerve fiber density can be assessed using skin biopsy. A decrease of this density is used to diagnose small fiber neuropathy, despite the absence of normative data in a selected normal population. To establish a normative set of data matched for age and sex is absolutely needed to evaluate the sensibility and specificity of this test.


Eligibility criteria: Inclusion Criteria:

* Man or woman between 20-80 years old
* Normal subjects without pain and neurological impairment
* No history of neurological disorder
* Normal neurological examination
* Normal ECG
* Normal clotting sample from less than 6 months
* Available by phone

Exclusion criteria :

* History of alcoholic intoxication or chemotherapy
* History of diabetes, kidney insufficiency, monoclonal gammapathy, B/C hepatitis, HIV, coeliac disease, sicca syndrome, raynaud syndrome, systemic erythematous lupus, Fabry disease, amylosis, vascularitis
* Contraindication to xylocaïn with adrenalin
* At the site of biopsy : surgery, skin pathology, infection, vascular insufficiency
* Innate or acquired immunosuppression
* Innate or acquired clotting abnormality

Primary outcomes:
measure: Measure density of intraepidermic nervous fibres by optical and electronic microscopy in a population of healthy witnesses according to the age and the sex.
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Nancy
country: France
facility: CHU de Nancy
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Nicolas COLLONGUES, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06516211: Predicate and Lay User-HCP Comparison Study of a Multi-Level Urine HCG Pregnancy Test
Official title: A Candidate - Predicate Comparison and Lay User-HCP Comparison Study of the Clara(TM) Multi-Level Urine HCG Pregnancy Test
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pregnancy
Lead sponsor: Conceptra Biosciences, LLC
Sponsor class: INDUSTRY
First posted: 2024-07-23
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females over the age of 18, who are capable of becoming pregnant.

Brief summary: Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial center and provide a sample of urine from the same void for further testing.

Volunteers will then complete a product usage questionnaire and leaflet comprehension questionnaire at site.

Detailed description: Eligible volunteers will be recruited into the study and provide informed consent.

Volunteers will then test their urine sample with the investigational HPT according to the device Instructions For Use, and their results will be recorded. A sample of urine from the same void will be obtained for further testing by the healthcare provider (HCP) study technicians.

The HCP technician will then test the volunteer's sample with a second investigational HPT, a professional use pregnancy test and a HPT, the results of which will be used to provide the volunteer with her pregnancy test result. During technician testing, the volunteer will complete the device usability and leaflet comprehension questionnaires.

True pregnancy status will be determined by laboratory tests and clinical information.

Eligibility criteria: Inclusion Criteria:

* Females (persons assigned female at birth and not sterile) willing and able to provide written consent to Study participation
* Able to read and write in English or Spanish

Exclusion criteria:

* Persons employed in a healthcare or laboratory setting and/or with professional experience who conduct point of care urine tests
* Previous or current enrollment in a Clara™ Study
* Visually or otherwise impaired to a degree they are not able to readily read and follow instructions, or visualize the faint pink lines.
* Unwilling or unable to provide at least 12mls of urine specimen and any urine testing they are expected to receive as a part of their non-Study related care.

Primary outcomes:
measure: Lay-Professional Comparison
timeFrame: 1 day
Secondary outcomes:
measure: Predicate Comparison
timeFrame: 1 day
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: FPA Women's Health
state: California
Study officials:
References:
Clinical trial NCT00879411: Investigating the Effect of Telmisartan (Micardis®) on the Average 24h Blood Pressure of Therapy-naive and Therapy-experienced Patients
Official title: 24h BP Under Micardis in Daily Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-04-10
Enrollment: 670
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hypertensive patients

Brief summary: Practical experience report (PER) investigating the effect of Micardis® on the average 24h blood pressure of therapy-naive and therapy-experienced patients


Eligibility criteria: Inclusion criteria:

1. Patients who have recently been diagnosed with hypertension
2. Patients whose current blood pressure treatment are inadequate and needs to be revised are suitable for inclusion.

Exclusion criteria:

None (according to investigator)

Primary outcomes:
measure: Efficacy (Change of Systolic Blood Pressure)
timeFrame: baseline to 8 weeks
measure: Efficacy (Change of Diastolic Blood Pressure)
timeFrame: baseline to 8 weeks
Secondary outcomes:
measure: Overall Tolerability Scale
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT01850511: The Effect of Nasal Hair on Nasal Obstruction
Official title: The Effect of Vibrissae on Subjective and Objective Measures of Nasal Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Obstruction
Keywords: Nasal obstruction
Vibrissae
Nasal hair
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Nasal obstruction is a common complaint prompting presentation to an otolaryngologist. Many studies have been performed quantifying and describing the impact of a number of factors on symptoms of nasal obstruction, including anatomical, neoplastic, infectious, and inflammatory causes. Despite this scrutiny, no attention has been paid to the nasal vibrissae as a potential anatomical contributor to nasal obstruction. The proposed study intends to elucidate that contribution, if any exists.


Eligibility criteria: Inclusion Criteria:

* Presence of nasal vibrissae
* Able to tolerate rhinomanometry

Exclusion Criteria:

* Anatomical or other obvious cause of obstruction
* Claustrophobia with rhinomanometry mask

Primary outcomes:
measure: Nasal airflow/pressure
timeFrame: Participants will undergo assessment over a 30 minute period, no follow-up
measure: Subjective Nasal Obstruction
timeFrame: Participants will undergo assessment over a 30 minute period, no follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Grant Hamilton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ozturk AB, Damadoglu E, Karakaya G, Kalyoncu AF. Does nasal hair (vibrissae) density affect the risk of developing asthma in patients with seasonal rhinitis? Int Arch Allergy Immunol. 2011;156(1):75-80. doi: 10.1159/000321912. Epub 2011 Mar 30.
Clinical trial NCT03719911: Evaluating the Impact of a Technologically-Enhanced Personal Coaching Program on Hemoglobin A1c in Type 2 Diabetics
Official title: Evaluation of the Effects of a Technologically-Enhanced Personal Coaching Program on Hemoglobin A1c in Type 2 Diabetics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Welkin Health
Sponsor class: OTHER
Collaborators: name: LifeScan
First posted: 2018-10-25
Enrollment: 72
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-arm 24-week pre-post study
Primary purpose: TREATMENT

Brief summary: Participants diagnosed with Type 2 diabetes receive personal coaching from a Certified Diabetic Educator (CDE) over a six-month period. The coaching program is enhanced using an mobile application and care management platform.

Detailed description: Participants diagnosed with Type 2 diabetes receive personal coaching from a Certified Diabetic Educator (CDE) over a six-month period. The coaching program is enhanced by integrating a participant-facing mobile application with the coaching platform. Blood glucose test results automatically populate the coaching platform, providing the CDE with information that may better support their coaching efforts.

The participants complete Diabetes Self Management Education (DSME) learning modules for the first 7-12 weeks. Following completion of the modules, the coach continues to provide support to the participant until 24 weeks after the participant's enrollment.

Eligibility criteria: Inclusion Criteria:

* Lives in the United States
* Speaks and understands English
* Has a Type 2 diabetes mellitus diagnosis
* Has a LifeScan Verio Flex blood glucose meter, which is connected to OneTouch Reveal ® app
* Has a verified A1c ≥ 8%
* Willing to participate in coaching program

Exclusion Criteria:

* Uses a continuous glucose monitoring device
* Currently pregnant
* Unable to make lifestyle behavioral changes due to a cognitive or physical disability
* Has end stage renal disease (ESRD) diagnosis
* Is not able to read or understand English

Primary outcomes:
measure: Change in Hemoglobin A1c
timeFrame: A1c measured at baseline, at 12 weeks since study enrollment, and at 24 weeks since enrollment, which marks the participant's completion of the study
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Welkin Health
state: California
Study officials:
affiliation: Welkin Health
name: Kristin Neland, BSN, MPH
role: PRINCIPAL_INVESTIGATOR
References: