louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00858286: A Follow-up Survey to Compare Stable Dosing (SERETIDE) With SYMBICORT, SMART, Maintenance and Reliever Therapy in One Inhaler in Moderate and Severe Asthmatics.
Official title: Follow-up Survey to Compare Stable Dosing (SERETIDE) With SYMBICORT SMART, Maintenance and Reliever Therapy in One Inhaler in Moderate and Severe Asthmatics.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-03-09
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose with this study is to describe in detail the control or lack of control of asthma, based on two different dosing strategies, regular treatment with SERETIDE in a stable dosing with short acting beta-2 agonists as needed, or maintenance treatment with SYMBICORT and using the same inhaler with SYMBICORT as needed.

Detailed description: The purpose with this study is to describe in detail the control or lack of control of asthma, based on two different dosing strategies. No therapy intervention is made with existing prescribed medications (SERETIDE or SYMBICORT), but evaluations outside standard care is made by evluations with diary cards, questionnaires, PEF evaluations and spirometry which is regarded as the intervention by the Swedish Authorities.

Eligibility criteria: Inclusion Criteria:

* written informed consent
* 18 years or above
* able to fill in questionnaires and perform PEF measurements
* asthma diagnosis and prescribed SERETIDE or SYMBICORT, either regular treatment using SERETIDE in a stable dosing and short acting B2 agonists as needed, or maintenance treatment with SYMBICORT but also using same inhaler SYMBICORT as needed

Exclusion Criteria:

* no other lung disease
* neurological disease with psychological handicap
* cerebro-vascular disease with handicap
* un-stable cancer
* known or planned pregnancy during the time of the study
* subjects who have serious uncontrolled disease

Primary outcomes:
measure: asthma control based on GINA guidelines from 2007.
timeFrame: 3 months
Secondary outcomes:
measure: Quality of Life, Health economics and exacerbations
timeFrame: 3 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04468386: Specimen Collection Study Protocol
Official title: Specimen Collection Study Protocol; Internal Biomerica Normal Specimen Collection and Banking for Use in COVID-19 Serological Product Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focus in on Collecting Paired Specimens for Matrix Equivalency
Lead sponsor: Biomerica
Sponsor class: INDUSTRY
First posted: 2020-07-13
Enrollment: 47
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of subjects identified as meeting the inclusion/exclusion criteria from Biomerica employees and/or friends and family of Biomerica's employees. There will be no outside advertising or recruiting. All subjects must be willing to sign the informed consent and undergo the venipuncture and finger stick blood collection process and perform the nasal swab collection.

Brief summary: The specimens collected will be used to evaluate matrix equivalency in an immunoassay in development for the detection of IgG or IgA or IgM antibodies to SARS - CoV2 in human serum. These reagents are for in vitro diagnostic use only.

Detailed description: The objective of this study is to acquire paired serum, plasma and whole blood collected on a collection card from subjects with no known history of COVID-19 infection. The specimens will be collected at Biomerica in Irvine CA for specimen collection, banking, and matrix equivalency studies for projects in development at Biomerica for detection to IgG or IgA or IgM antibodies to Sars-CoV2 antibodies. Subject will also be asked to self-collect a nasal swab for COVID-19 PCR

Eligibility criteria: Inclusion Criteria:

* Aged 21 and older
* Able to read, speak, and understand English
* Must weigh a minimum of 110 pounds
* Willing and able to donate 20 mLs of whole blood via venipuncture. \[approximately ˂ 2 tablespoons\]
* Willing and able to donate 0.040 mLs of whole blood via fingerstick
* Willing and able to sign the informed consent (self or authorized representative)
* Willing and able to self-collect a nasal swab per the provided instruction shee

Exclusion Criteria:

* Aged less than 21 years old
* Unable to provide consent.
* Unable to donate blood via venipuncture and fingerstick.
* Unable to self-collect a nasal swab

Primary outcomes:
measure: Matrix Equivalency
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Biomerica, Inc.
state: California
Study officials:
affiliation: Biomerica, Inc.
name: Elisabeth Laderman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01617486: Achieving Energy Balance in Post Partum Teens
Official title: Achieving Energy Balance in Overweight Post Partum Teens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-06-12
Enrollment: 1325
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This proposal will test Balance Adolescent Lifestyle Activities and Nutrition Choices for Energy (BALANCE), a multilevel intervention administered through Parents as Teachers (PAT) and designed to reduce overweight in postpartum teens. The intervention will focus on the replacement of 'obesogenic' patterns (such as high soda intake, excess portion size, and sedentary activity) with 'energy' patterns (such as water consumption, appropriate portion size, and walking).


Eligibility criteria: Inclusion Criteria:

* between 12 to 20 years of age
* less than 1 year post partum
* current participant in Parents as Teachers

Exclusion Criteria:

* currently pregnant

Primary outcomes:
measure: BMI change at 6 month post assessment
timeFrame: Baseline and 6 month post assessment
measure: BMI change at 1 year post assessment
timeFrame: Baseline to 1 year post assessment
Secondary outcomes:
measure: reduce caloric intake
timeFrame: baseline and 6 month post test
measure: Engage in moderate intensity walking
timeFrame: Baseline and 6 month Post test
measure: Improve their knowledge of energy patterns
timeFrame: Baseline and 6 month Post test
measure: Increase frequency of performance of energy patterns
timeFrame: Baseline and 6 month post test
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Debra Haire-Joshu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haire-Joshu D, Yount BW, Budd EL, Schwarz C, Schermbeck R, Green S, Elliott M. The quality of school wellness policies and energy-balance behaviors of adolescent mothers. Prev Chronic Dis. 2011 Mar;8(2):A34. Epub 2011 Feb 15.
citation: Haire-Joshu D, Schwarz C, Budd E, Yount BW, Lapka C. Postpartum teens' breakfast consumption is associated with snack and beverage intake and body mass index. J Am Diet Assoc. 2011 Jan;111(1):124-30. doi: 10.1016/j.jada.2010.10.009.
citation: Haire-Joshu DL, Schwarz CD, Peskoe SB, Budd EL, Brownson RC, Joshu CE. A group randomized controlled trial integrating obesity prevention and control for postpartum adolescents in a home visiting program. Int J Behav Nutr Phys Act. 2015 Jun 26;12:88. doi: 10.1186/s12966-015-0247-8.
Clinical trial NCT02862886: Study of the Effect of Beta-3 Adrenergic Receptor Agonists on Oxidative Stress and Signalling Pathways Implicated in Remodelling of the Uteroplacental Space: Experimental in Vitro Approach on Myometrial Tissue Explants
Official title: Study of the Effect of Beta-3 Adrenergic Receptor Agonists on Oxidative Stress and Signalling Pathways Implicated in Remodelling of the Uteroplacental Space: Experimental in Vitro Approach on Myometrial Tissue Explants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: CHRONOLOGICAL DESCRIPTION OF THE STUDY

1. Information provided to study participants
2. Collection of written informed consent
3. Harvesting of myometrial biopsies
4. Creation of tissue explants using myometrial biopsies
5. Stimulation of the explants with LPS
6. Study of the effect of SAR150640 (beta3-adrenergic agonist) on LPS-induced oxidative stress Moreover, demonstrating the ability of beta3-adrenergic receptor agonists to prevent the appearance of oxidative stress and its consequences on tissues, as a complement to previous studies, is an additional argument for the clinical development of this class of pharmaceuticals in the management of threatened premature delivery and labour induction.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Patients with national health insurance cover
* Patients with a normal pregnancy requiring a caesarean section for obstetrical reasons
* No obvious infectious context

Exclusion Criteria:

* Obvious inflammatory or autoimmune diseases
* Suspected or confirmed infectious context, including HIV, HCV HBV
* Coagulation disorders
* Preexisting or gestational diabetes

Primary outcomes:
measure: simultaneous assays of 4-amino-5-methylamino-2,7-difluorescein (DAF) / Dihydroethidium (DHE) markers by the technique of high pressure liquid chromatography
timeFrame: The biopsy of myometrium is done specifically for this study in a surgical unit after delivery of the child, in women with a normal pregnancy but requiring a caesarean
Secondary outcomes:
measure: Characterization of signalling pathways induced by oxidative stress during inflammation
timeFrame: The biopsy of myometrium is done specifically for this study in a surgical unit after delivery of the child, in women with a normal pregnancy but requiring a caesarean
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT01226186: Self Medication With Oral Morphine After Total Knee Arthroplasty.
Official title: Self Medication With Oral Morphine After Total Knee Arthroplasty. A Randomised Controlled Trial Comparing Self Medication With Standard Nurse Dispensing. Is There a Difference in Morphine Consumption, Pain, Patient Satisfaction or Safety?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Knee Replacement
Pain Control
Keywords: Knee replacement
Pain control
Self medication
Lead sponsor: The Royal Bournemouth Hospital
Sponsor class: OTHER
Collaborators: name: Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
First posted: 2010-10-22
Enrollment: 144
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: The study aims to compare two post operative pain management strategy's, traditional nurse dispensed pain control versus patient self medication. The investigators aim to establish if patients who self medicate have differing pain levels than those who take nurse dispensed oral morphine.


Eligibility criteria: Inclusion Criteria:

* Patients requiring total knee replacement surgery willing to provide written, informed consent.

Exclusion Criteria:

* Unable to safely self medicate.

Allergy to morphine.

Unable to provide consent.

Contraindication to the standardised anaesthetic or standard postoperative care.

Not consenting to an element of the standardised anaesthetic.

Pre-operative use of strong opiates e.g. Oramorph, MST, Oxynorm.

Primary outcomes:
measure: To establish if patients who self medicate with oral morphine have differing pain levels than those who take nurse dispensed oral morphine.
timeFrame: one year
Secondary outcomes:
measure: To identify if patients who self medicate with oral morphine take a significantly different amount of morphine compared with those who take nurse dispensed oral morphine.
timeFrame: one year
measure: To compare whether patients who self medicate with oral morphine have a significantly altered level of side effects compared with those who take nurse dispensed oral morphine.
timeFrame: one year
Other outcomes:
Locations:
city: Bournemouth.
country: United Kingdom
facility: Derwent Unit, Royal Bournemouth Hospital.
state: Dorset.
Study officials:
affiliation: Poole Hospital NHS Foundation Trust
name: Jonathan Linton, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01064986: The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers
Official title: The Effects of Hydrocortisone in Endotoxemia in Normal Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infections
Keywords: Immune System
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2010-02-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Corticosteroids are substances produced by the adrenal gland to help the body fight against infection or injury. Hydrocortisone is a man-made form of this substance. Endotoxin is a man-made substance, which causes the body to "mimic" sickness(fever,chills,and achiness)for a few hours. This study is designed to give hydrocortisone before and after Endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by the Endotoxin.

Detailed description: The body's immune response to injury otr infection is very complex. Immune cell activity, the release of specific mediators (such as proteins), genetics (Deoxyribonucleic acid or DNA) and/or the body's "instructions" for making proteins (Ribonucleic Acid or RNA) may effect the body's clinical response to a stress such as an infection.Hydrocortisone is a substance produced by the body (in the adrenal gland)in response to stress such as infection or injury. Endotoxin is a man- made substance, which causes the body to "mimic" sickness (fever, chills, and achiness) for a few hours. This study is designed to give hydrocortisone before and/or after endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by endotoxin.In addition, this study may determine whether any of the above(proteins,DNA,RNA,etc.) correlate with or affect the body's response to hydrocortisone and/or endotoxin. This will enable the investigator to better understand whether treatment with this substance can alter the body's immune response.

Eligibility criteria: Inclusion Criteria:

* General good health as demonstrated by medical history, physical\& laboratory tests
* Age between 18 and 40 years
* Written informed consent prior to the performance of any study related procedures

Exclusion Criteria:

* History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension
* Any medication taken in past 48 hrs (except birth control)
* Recent history of alcohol or drug abuse
* Unable to provide written informed consent
* Exposure to any experimental agent or procedure within 30 days of study
* Pregnant or breast-feeding

Primary outcomes:
measure: Physiological, Hematological, Immunological Responses
timeFrame: 0.5-24 hrs post Endotoxin administration
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers-RWJMS
state: New Jersey
Study officials:
affiliation: Rutgers-RWJMS
name: Siobhan Corbett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00801086: Efficacy Study of Tempol to Prevent Hair Loss From Radiotherapy to the Brain
Official title: Phase II Double-Blind, Placebo-Controlled Study of the Safety and Preliminary Effectiveness of MTS-01 for the Prevention of Alopecia Induced by Whole Brain Radiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Alopecia
Keywords: Alopecia
Hair loss
Radiation
Whole brain radiotherapy
Radiation-induced alopecia
Lead sponsor: Mitos Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-12-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hair loss occurs commonly as a result of radiotherapy administered to the brain, and this can contribute to the distress and social isolation of patients with advanced cancer. In this study a topical gel will be applied directly to the scalp during each dose of radiotherapy. The goal is to determine to what extent the experimental drug is successful in lessening the hair loss.


Eligibility criteria: Inclusion Criteria:

* Metastatic cancer to the brain for which palliative whole brain radiotherapy is recommended.
* Hair that covers the scalp and is at least 1/4 inch in length

Exclusion Criteria:

* Receiving chemotherapy known to cause alopecia within 60 days of study or during the study.
* Pre-existing alopecia
* Previous brain radiotherapy
* scalp metastases or scalp wounds
* use of hair dyes

Primary outcomes:
measure: Effectiveness will be based on a comparison of hair retention scores between MTS-01 and placebo.
timeFrame: Assessments occur weekly during treatment and follow-up assessments occur for 12 weeks following treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: James Metz, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05777486: Dietary and Cognitive Effects of Food Ads Posted by TikTok Influencers
Official title: A Randomized Controlled Trial Examining How TikTok Influencers' Posts With Vs. Without Food Differentially Affect Youth Dietary Choices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Calorie Consumption
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized and controlled experimental study to evaluate how influencer food ads on TikTok affect calorie purchases among youth (ages 10-13). Participants will be randomized to one of two conditions: (1) seeing an influencer with food or (2) seeing an influencer without food. Participants will complete a 15-minute survey in which they will be randomized to one of two conditions and view and rate TikTok influencer ads associated with their condition. Then they will complete a food purchasing task in which they will shop in an online store that will display six food items and six beverages. Finally, they will answer demographic questions (e.g., self-reported height and weight) and view a debriefing summary that describes the full purpose of the study.


Eligibility criteria: Inclusion Criteria:

* Participants must be 10-13 years old
* Identify as only non-Latino White or only Black/African American
* Report that they log into TikTok at least once daily
* Read and speak English

Exclusion Criteria:

• Any criteria not met as listed above will bar an adolescent from participating in the study

Primary outcomes:
measure: Calorie Count from Snacks Chosen at Virtual Vending Machine
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Marie Bragg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04200196: Improvement of Anxiety Management During a Venous Puncture About Children with a Participatory Entertainment Method
Official title: Improvement of Anxiety Management During a Venous Puncture About Children 3 to 6 Years, with a Participatory Entertainment Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Keywords: anxiety
children
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 116
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Intervention model description: This study is an interventional prospective controlled study with 2 arms:

* the "fabrique à histoire" arm : production and listening a story by the children
* the controlled arm: usual care (to sing, blow up a baloon, etc)
Primary purpose: OTHER

Brief summary: The purpose of this study is to demonstrate an anxiety decrease about children 3 to 6 years during a venous puncture with the "fabrique à histoire".

Detailed description: The purpose of this study is to demonstrate an anxiety decrease about children 3 to 6 years during a venous puncture with the "fabrique à histoire".

the study will compare the "fabrique à histoire"(Lunii(R)) with the usual care.

Eligibility criteria: Inclusion Criteria:

* Children 3 to 6 years in pediatric emergency needing to venous puncture
* Oral consent by children
* Informed and signed consent by tenured of parent authority
* To have Anaesthetic patch 45 minutes or more before the venous puncture

Exclusion Criteria:

* To have Anaesthetic patch less than 45 minutes before the venous puncture because of necessity to blood test or an other emergency
* Necessity to analgesic 3 emergency
* Necessity to MEOPA
* Minor parents
* Assessment of anxiety is not possible because of comorbidity
* Anterior participation to these study

Primary outcomes:
measure: modified Yale Preoperative Anxiety Scale (mYPAS)
timeFrame: During venipuncture, an average of 1,5 hours
measure: modified Yale Preoperative Anxiety Scale (mYPAS)
timeFrame: through study completion, an average of 2 hours
Secondary outcomes:
measure: Children face scale
timeFrame: through study completion, an average of 2 hours
measure: FLACC Scale
timeFrame: through study completion, an average of 2 hours
measure: Parent anxiety assessment
timeFrame: through study completion, an average of 2 hours
measure: Parent pain assessment
timeFrame: through study completion, an average of 2 hours
measure: Number of venous puncture before success
timeFrame: through study completion, an average of 2 hours
measure: Venous puncture success
timeFrame: through study completion, an average of 2 hours
measure: Time before venous puncture success
timeFrame: through study completion, an average of 2 hours
measure: Caregivers feedback
timeFrame: through study completion, an average of 2 hours
measure: Parents feedback
timeFrame: through study completion, an average of 2 hours
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
state: Finistère
Study officials:
References: