louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04909372: Environmental Labelling in a Virtual Supermarket
Official title: Impact of Environmental Labelling on Food Choices : a Randomized Controlled Trial in a Virtual Reality Supermarket
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet, Healthy
Food Selection
Keywords: labelling
food choice
Lead sponsor: Centre des Sciences du Goût et de l'Alimentation
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A 2-arm randomised control trial (with and without labels) will be conducted to test the effects of an environmental label on food choices in a virtual supermarket. A sample of 130 participants will take part in two shopping tasks: 1/ selection of 3 products to prepare a home-made dish, and 2/ selection of a ready-to-eat dish. These two tasks will be repeated for two scenarios: 1/ participants will be asked to select the foods for usual meals, and 2/ participants will be asked to select the foods for environmentally-friendly meals. This experimental design will allow to compare food choices in the presence vs. the absence of an environmental label and to investigate whether the label is informative and likely to help individuals to choose more environmental-friendly food options when explicitly asked to do so.

Detailed description: See attached protocol documents

Eligibility criteria: Inclusion Criteria:

* Responsible for a substantial proportion of household grocery shopping
* Fluent in French

Exclusion Criteria:

* Dietary restrictions (vegetarian, vegan, allergies, intolerance, ...)
* Uncorrected eye problems
* Known symptoms of nausea and dizziness when wearing a virtual reality headset

Primary outcomes:
measure: Environmental impact of the food items selected
timeFrame: 15 minutes (the time frame denotes time taken to make the food choice task and there is no follow up)
Secondary outcomes:
measure: Familiarity for the food items selected
timeFrame: 15 minutes (the time frame denotes time taken to make the food choice task and there is no follow up)
measure: Liking for the food items selected
timeFrame: 15 minutes (the time frame denotes time taken to make the food choice task and there is no follow up)
measure: Nutritional quality of the food items selected
timeFrame: 15 minutes (the time frame denotes time taken to make the food choice task and there is no follow up)
measure: Level of processing of the food items selected
timeFrame: 15 minutes (the time frame denotes time taken to make the food choice task and there is no follow up)
measure: Price of the food items selected
timeFrame: 15 minutes (the time frame denotes time taken to make the food choice task and there is no follow up)
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre des Sciences du Goût et de l'Alimentation
Study officials:
affiliation: Centre des Sciences du Goût et de l'Alimentation
name: Lucile Marty, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04459572: As an Early Indicator Biomarker of Prognosis and Mortality in Children With Sepsis and Septic Shock: suPAR
Official title: The Investigation of Soluble Urokinase Plasminogen Activator Receptor (suPAR) as an Early Indicator of Prognosis and Mortality in Children With Sepsis and Septic Shock: A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Sepsis, Severe
Keywords: sepsis
suPAR
septic shock
children
mortality
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 72
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The sepsis and septic shock remain major causes of child morbidity and mortality, despite the use of modern antibiotics and resuscitation therapies. Recent interest has focused on biomarkers for early diagnosis, and evaluation the outcomes of sepsis; but there is a still lack of early diagnosis and timely intervention for sepsis in the emergency department (ED). The primary aim was to investigate the role of C-Reactive Protein(CRP), Procalcitonin(PCT), soluble-urokinase plasminogen activator receptor(suPAR) and Presepsin in the early stratification of patients with sepsis. The usefulness of pediatric Sequential Organ Failure Assessment (pSOFA) for predicting of the mortality and the rate of PICU admission in children with septik shock were also investigated. This prospective pilot study was conducted at academic pediatric ED between September 2017-June 2018. All children who met sepsis criteria admitted to ED were involved to study. They kept following up after ED management and their blood samples were taken upon admission on day 0, 1, 2, 4 and 7. The definition made as sepsis, severe sepsis and septic shock. At the same period, 100 healthy children chosen as the control group. The patient characteristics, clinical features, diagnosis, co-morbidities, source of infection, laboratory results (CRP, PCT, lactate, suPAR and Presepsin) and treatments were recorded. The pSOFA score was calculated during first hour of admission. Length of stay in ED and hospital was noted. The main outcome measure was in 7 and 30-day mortality.


Eligibility criteria: Inclusion Criteria:

* \<18 years
* Admitted to emergency department with sepsis

Exclusion Criteria:

* \>18 years
* Diagnosed non-sepsis

Primary outcomes:
measure: suPAR values in septic chock
timeFrame: 7 days
Secondary outcomes:
measure: Presepsin level
timeFrame: 7 days
measure: C-Reactive Protein(CRP) level
timeFrame: 7 days
measure: Procalcitonin (PCT) level
timeFrame: 7 days
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University School of Medicine
Study officials:
References:
Clinical trial NCT01465672: Copeptin as a Diagnostic Marker in the Management of Neurosurgical Patients With Disturbance of Water Homeostasis
Official title: Copeptin as a Diagnostic Marker in the Management of Neurosurgical Patients With Disturbance of Water Homeostasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pituitary Adenoma
Keywords: copeptin
SIADH
Diabetes insipidus
transphenoidal pituitary adenoma resection
pituitary adenoma
tumors close to pituitary gland
tumors close to hypothalamus
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Kantonsspital Aarau
First posted: 2011-11-06
Enrollment: 125
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing transphenoidal pituitary adenoma resection and patients with transcranial surgery of tumors close to the pituitary gland and hypothalamus.

Brief summary: Water imbalance and consecutive electrolyte disturbances are common in the postoperative course of neurosurgical patients after pituitary surgery. Diabetes insipidus (DI) may complicate the postoperative course in as many as 30% of patients. Early and accurate diagnosis of water and electrolyte disturbances postoperatively is important for an adequate fluid and drug administration. However, identifying the causes is challenging/ ambiguous in clinical practice. Levels of antidiuretic hormone (ADH) might contribute to a straightforward diagnosis, though, its measurement is cumbersome. ADH is derived from a larger precursor peptide along with copeptin, which is a more stable peptide directly mirroring the production of ADH. Copeptin can be assayed readily in plasma. Aim: To investigate whether copeptin can accurately diagnose postoperative disturbances of water homeostasis (i.e. Diabetes insipidus and SIADH) in a cohort of patients undergoing intracranial tumor surgery.


Eligibility criteria: Inclusion Criteria:

* All consecutive patients who undergo surgery for an intra- or suprasellar lesion, either by craniotomy or by transphenoidal resection.

Primary outcomes:
measure: diagnostic accuracy, i.e. difference of copeptin levels between patients without and patients with postoperative DI, of copeptin in the diagnosis of water disturbance in neurosurgical patients
timeFrame: daily during hospital stay of the patient, on average 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
References:
citation: Winzeler B, Zweifel C, Nigro N, Arici B, Bally M, Schuetz P, Blum CA, Kelly C, Berkmann S, Huber A, Gentili F, Zadeh G, Landolt H, Mariani L, Muller B, Christ-Crain M. Postoperative Copeptin Concentration Predicts Diabetes Insipidus After Pituitary Surgery. J Clin Endocrinol Metab. 2015 Jun;100(6):2275-82. doi: 10.1210/jc.2014-4527. Epub 2015 Apr 29.
Clinical trial NCT02358772: Comparison of Pre-hospital and In-hospital Iv-tPA Stroke Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Keywords: stroke
thrombolysis
STEMO
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-02-09
Enrollment: 658
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: acute ischemic stroke patients with thrombolytic treatment

Brief summary: This is a comparison of clinical outcomes between a pre-hospital and an in-hospital thrombolysis patient registry.


Eligibility criteria: Inclusion Criteria:

* Acute ischemic stroke diagnosis with thrombolytic treatment
* Admission via EMS
* Known premorbid status of need of assistance
* NIHSS before treatment available
* Time of onset (or last well seen) between 4:00am and 10:30pm

Exclusion Criteria:

* Unknown time of onset
* In-hospital thrombolysis despite decision against treatment because of contraindications in STEMO

Primary outcomes:
measure: modified Rankin Scale (mRS) score
timeFrame: three months after event
Secondary outcomes:
measure: modified Rankin Scale (mRS) score
timeFrame: three months after event
measure: modified Rankin Scale (mRS) score
timeFrame: three months after event
measure: modified Rankin Scale (mRS) score
timeFrame: three months after event
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité
Study officials:
affiliation: Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin
name: Heinrich J Audebert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ebinger M, Winter B, Wendt M, Weber JE, Waldschmidt C, Rozanski M, Kunz A, Koch P, Kellner PA, Gierhake D, Villringer K, Fiebach JB, Grittner U, Hartmann A, Mackert BM, Endres M, Audebert HJ; STEMO Consortium. Effect of the use of ambulance-based thrombolysis on time to thrombolysis in acute ischemic stroke: a randomized clinical trial. JAMA. 2014 Apr 23-30;311(16):1622-31. doi: 10.1001/jama.2014.2850.
citation: Kunz A, Ebinger M, Geisler F, Rozanski M, Waldschmidt C, Weber JE, Wendt M, Winter B, Zieschang K, Fiebach JB, Villringer K, Erdur H, Scheitz JF, Tutuncu S, Bollweg K, Grittner U, Kaczmarek S, Endres M, Nolte CH, Audebert HJ. Functional outcomes of pre-hospital thrombolysis in a mobile stroke treatment unit compared with conventional care: an observational registry study. Lancet Neurol. 2016 Sep;15(10):1035-43. doi: 10.1016/S1474-4422(16)30129-6. Epub 2016 Jul 16.
citation: Nolte CH, Ebinger M, Scheitz JF, Kunz A, Erdur H, Geisler F, Braemswig TB, Rozanski M, Weber JE, Wendt M, Zieschang K, Fiebach JB, Villringer K, Grittner U, Kaczmarek S, Endres M, Audebert HJ. Effects of Prehospital Thrombolysis in Stroke Patients With Prestroke Dependency. Stroke. 2018 Mar;49(3):646-651. doi: 10.1161/STROKEAHA.117.019060. Epub 2018 Feb 19.
Clinical trial NCT01307072: Compliance to Ophthalmic Follow-up Examinations and Surgical Outcome for Proliferative Diabetic Retinopathy
Official title: Compliance to Ophthalmic Follow-up Examinations Affect Outcome of Vitrectomy for Proliferative Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proliferative Diabetic Retinopathy
Keywords: periodic examinations, compliance
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2011-03-02
Enrollment: 94
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients that underwent their first vitreous surgery for proliferaftive diabetic retinopathy

Brief summary: The relationship between the surgical outcome of vitreous surgery for proliferative diabetic retinopathy and the compliance to ophthalmic follow-up examinations was evaluated.

Detailed description: The medical records of 94 patients that had undergone vitreous surgery for proliferative diabetic retinopathy (PDR) and were followed for at least 6 months were reviewed. The subjects were divided into three groups; the never-treated group consisting of patients who had no previous ophthalmic examination until the first visit when vitreous surgery was prescribed; the non-compliant group consisting of patients with a history of missing ophthalmic examination over a one year period, and the compliant group consisting of patients who had ophthalmic examinations at least once a year. The evaluations included age, gender, plasma level of glycosylated hemoglobin (HbA1c) at the preoperative examination, presence of preoperative panretinal photocoagulation, preoperative best-corrected visual acuity (BCVA), postoperative BCVA at the final examination, status of the PDR, the numbers of vitreous surgeries, and presence of pre- and postoperative neovascular glaucoma.

Eligibility criteria: Inclusion Criteria:

* One hundred and twenty-eight eyes of 94 patients that had undergone vitreous surgery for proliferative diabetic retinopathy.
* Type 2 diabetes.

Exclusion Criteria:

* The patients were not followed more than 6 months.

Primary outcomes:
measure: Preoperative status
timeFrame: Preoperative period
measure: Preoperative status
timeFrame: Preoperative period
Secondary outcomes:
measure: Postoperative status
timeFrame: up to 1 year
measure: Postoperative status
timeFrame: up to 1 year
measure: Postoperative status
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Mitaka
country: Japan
facility: Kyorin Eye Center
state: Tokyo
Study officials:
affiliation: Kyorin Eye Center
name: Makoto Inoue, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01334372: Intensive Outpatient Treatment for Suicidal Veterans
Official title: Intensive Outpatient Treatment for Suicidal Veterans: A Randomized Clinical Trial and Feasibility Investigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidality
Keywords: suicide
veterans
assessment
CAMS
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
Collaborators: name: US Department of Veterans Affairs
name: The Catholic University of America
First posted: 2011-04-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This investigation is a feasibility study conducted in a VA outpatient treatment setting. The study is designed to test the feasibility of implementing a novel way of working with suicidal patients, the Collaborative Assessment and Management of Suicidality (CAMS). The primary purpose of the proposed project is to determine if it is possible to train clinicians working in the Mental Health Clinic at the Denver VA Medical Center (VAMC) to utilize this therapeutic framework. This project is extremely timely in relation to expectations of future increased clinical demands among potentially high-risk Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) veterans who may become suicidal in the years to come.


Eligibility criteria: Inclusion Criteria:

1. Suicidality endorsed during the regular Mental Health intake interview or at the time of admission.
2. Over the age of 18 years.
3. New or returning patients to the VA MHC.
4. Living within the larger Denver metropolitan region during the duration of the treatment.
5. Willing to travel to the ECHCS Denver VAMC at times other than scheduled therapy appointments to complete follow-up assessment measures.

Exclusion Criteria:

1. Psychosis that would interfere with an individual's ability to provide informed consent.
2. Imminent suicidality with the need for immediate psychiatric hospitalization, as defined above in the Background section, at the time of MH intake.
3. Current involuntary status for psychiatric hospitalization.
4. Inability to adequately respond to questions regarding the informed consent procedure. See Special Consent Issues section below.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Visn 19 Mirecc
state: Colorado
Study officials:
affiliation: VISN 19 MIRECC
name: Lisa A Brenner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02547272: Epidemiological Study of Intestinal Colonization With Staphylococcus Aureus
Official title: Epidemiological Study of Intestinal Colonization With Staphylococcus Aureus in a Cohort of Adult Patients Hospitalized in Intensive Care at the University Hospital of St Etienne.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Staphylococcus Aureus
Keywords: Intensive care
S Aureus
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-09-11
Enrollment: 400
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: Patients hospitalized in intensive care

Brief summary: Nasal colonization with S. aureus is a risk factor for infection with this bacterium. A methodologically well conducted study of S. aureus bacteremia showed that 80% of S. aureus bacteremia with are due to the strain isolated in the nasal level. However, as part of a study coordinated by the CHU of Saint-Etienne, less than 50% of infections in prosthetic orthopedic devices have been linked to nasal carriage . Outside of exogenous infections, intestinal colonization with S. aureus could be an alternative source of endogenous infections with the waning of orthopedic surgery. In the general population, considering that about one third of the subjects were colonized with S. aureus nasal level and 1 in 5 in the intestine However the proportion of exclusive intestinal porting is not well known .

This study will analyze, among ICU patients, porting S. aureus nasal and rectal level. It will better clarify the relationship between nasal and rectal ports and the risk of developing an infection.

Detailed description: The adult patients hospitalized in intensive care at the University Hospital of Saint-Etienne have a multiresistant bacteria porting screening at the nose and rectum at admission and then once a week. These samples will be carried unchanged way for the study but will also be a research S Aureus

Eligibility criteria: Inclusion Criteria:

* patients hospitalized in intensive care and benefiting from a screening multiresistant bacteria in nasal and rectal level under routine care

Exclusion Criteria:

* refusal of the patient's family

Primary outcomes:
measure: prevalence of S. aureus colonization at rectal level
timeFrame: 1 month
Secondary outcomes:
measure: S. aureus strains similar to nasal and rectal level
timeFrame: 1 month
Other outcomes:
Locations:
city: St Etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Philippe BERTHELOT, Md-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02902172: NSAID Use in Postpartum Hypertensive Women
Official title: NSAID Use in Postpartum Hypertensive Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: St. Louis University
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 36
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Women who have the diagnosis of hypertension (pre-pregnancy and pregnancy induced) and deliver an infant via vaginal delivery will be placed into two groups in the postpartum period. One group will receive Ibuprofen for pain control and the other group will be given Tylenol. Blood pressures during the postpartum period will then be collected and compared in order to see if NSAIDs use increases blood pressure.

Detailed description: The patients who have a vaginal delivery and have the diagnosis of hypertension in pregnancy will be randomized to either Ibuprofen use or acetaminophen use during the postpartum period. Standard blood pressure monitoring in the postpartum period will be followed to help determine if there is a significant rise in the women who use NSAIDS in the postpartum period versus those that use acetaminophen.

Groups will be divided into women with chronic hypertension, women with chronic hypertension with superimposed preeclampsia, women with preeclampsia without severe features, women with preeclampsia with severe features, women with gestational hypertension without severe range blood pressures, and women with gestational hypertension with severe range blood pressures.

Recruitment will last 36 months. Patients will be monitored during their postpartum stay (typical 2 days) with blood pressure measurements. An additional 12 months will be needed for data analysis and publication.

Eligibility criteria: Inclusion Criteria:

* vaginal delivery
* diagnosis of chronic hypertension, chronic hypertension with superimposed preeclampsia
* preeclampsia without severe features
* preeclampsia with severe features gestational hypertension without severe range blood pressures
* gestational hypertension with severe range blood pressures
* singleton pregnancies

Exclusion Criteria:

* Cesarean Delivery
* no diagnosis of hypertensive disorder
* chronic or acute renal disease
* allergy to ibuprofen or acetaminophen
* lupus
* multiple order pregnancies (twins, triplets)
* Narcotic addiction/ in treatment for substance abuse/ current prescription drug user/ current use of illegal drugs

Primary outcomes:
measure: Change in the Mean Systolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.
timeFrame: 2 days
Secondary outcomes:
measure: Change in the Mean Diastolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.
timeFrame: 2 days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Mary's Health Center
state: Missouri
Study officials:
affiliation: St. Louis University
name: Jennifer Goldkamp, MD
role: PRINCIPAL_INVESTIGATOR
References: