louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03836534: the Observance of Emergency Exit Treatments During the Stay of Care at the Exit of Reims Emergencies
Official title: Multicentric Prospective Study of the Observance of Outpatient Treatments in Reims During the Care Continuum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Coming to the Emergency Department for Any Reason
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2019-02-11
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the group studied only concern adults consulting in the emergency and leaving after their consultations, durning the permanence of care

Brief summary: The investigators would like to include patients consulting in a Accident and Emergency Department (AED) during the permanence of care the week of March 11 to 17, 2018. The data collection would concern socio-demographic data, their consultation to the AED, the follow-up given to the consultation and would take place by telephone contact of patients within 48 hours of the consultation.

why patients come to the emergency room, what are they waiting for? what are their main motivations? what do they do in emergencies, do they follow the treatments and recommendations?

Detailed description: Study of the observance of emergency exit treatments during the permanence of care. This is a descriptive study with a prospective data collection that does not alter the management of the patient. The study is epidemiological, cross-sectional, prospective inclusion.

The investigators would like to include patients consulting in a AED during the permanence of care the week of March 11 to 17, 2018. The data collection would concern socio-demographic data, their consultation to the AED, the follow-up given to the consultation and would take place by telephone contact of patients within 48 hours of the consultation.

The objective is to study the follow-up given by the consultation to the emergencies, in terms of compliance, follow-up of the recommendations, the objective sought by the patient coming to the emergency department.

Understand the motivation of the consultation and why the treatment was not followed where appropriate.

Is there a sociodemographic explanation or is it the health network that results in the saturation of emergency services? Does the system still meet the expectations of people using it?

Eligibility criteria: Inclusion Criteria:

* adults
* consultation during the early stages of care
* leaving after consultation
* agrees to participate in the study

Exclusion Criteria:

* minor patients
* permanently off care
* hospitalized patients
* refusal to participate in the study

Primary outcomes:
measure: adherence to treatment
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
Clinical trial NCT03229434: Mountain Hiking & Environmental Influences
Official title: Effects of Mountain Hiking on Physiological and Psychological Health Parameters With Special Focus on the Influence of the Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Keywords: affective responses
stress-related parameters
green exercise
Lead sponsor: Universitaet Innsbruck
Sponsor class: OTHER
Collaborators: name: Paracelsus Medical University
First posted: 2017-07-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: In a randomized crossover design, approximately 50 healthy participants will be randomly exposed to outdoor mountain hiking (approximately 6 hours each) in two different areas: an anthropogenically influenced area and in a widely pristine area.


Eligibility criteria: Inclusion Criteria:

* voluntary participation

Exclusion Criteria:

* pregnancy
* breastfeeding
* chronic or acute diseases (already existing or diagnosed during the study)
* unable to be physically active assessed by the Physical Activity Readiness Questionnaire

Primary outcomes:
measure: Change from baseline Cortisol (Saliva Sampling) at 6 hours
timeFrame: 6 hours
measure: Change from baseline subscales of mood survey scale at 6 hours
timeFrame: 6 hours
Secondary outcomes:
measure: Change from baseline blood pressure at 6 hours
timeFrame: 6 hours
measure: Change from baseline lung function at 6 hours
timeFrame: 6 hours
measure: Change from baseline respiratory gas analysis at 6 hours
timeFrame: 6 hours
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Department of Sport Science, Medical Section, University of Innsbruck
Study officials:
References:
citation: Niedermeier M, Einwanger J, Hartl A, Kopp M. Affective responses in mountain hiking-A randomized crossover trial focusing on differences between indoor and outdoor activity. PLoS One. 2017 May 16;12(5):e0177719. doi: 10.1371/journal.pone.0177719. eCollection 2017.
Clinical trial NCT06020534: Aortoiliac Stenosis in Kidney Transplantation
Official title: Safety and Efficacy of Kidney Transplantation in Patients With Aortoiliac Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aorto-Iliac Arterial Stenosis
Peripheral Arterial Disease
Kidney Transplant Failure
Keywords: aortoiliac arterial stenosis
peripheral arterial disease
kidney transplantation
outcomes
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 655
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020.

Brief summary: The impact of aortoiliac stenosis on kidney transplant patients remains unclear. This study aims to investigate the safety and efficacy of kidney transplantation in patients with aortoiliac stenosis.

Detailed description: Kidney transplantation is the optimal treatment for end-stage renal disease (ESRD). Unfortunately, not all ESRD patients are eligible for kidney transplantation. Aortoiliac stenosis, an increasingly common type of peripheral arterial disease in ESRD patients, is considered as relative contra-indication for kidney transplantation. There are several reasons for concern, such as the complexity of the vascular anastomosis and inferior life expectancy. Consequently, it is still debated whether patients with aortoiliac stenosis would benefit from kidney transplantation.

This study aimed to supplement current literature on the safety and efficacy of kidney transplantation in patients with aortoiliac stenosis. To achieve this, all patients undergoing kidney transplantation in Erasmus Medical Center between January 2010 and December 2020 were enrolled, and propensity score matching was used to minimize confounding factors. Additionally, long-term graft function was investigated to evaluate the impact of stenosis on graft function.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent kidney transplantation in the Erasmus Medical Center between January 2010 and December 2020

Exclusion Criteria:

* Patients who were under 18 years at transplantation
* Patients who underwent combined organ transplantation
* Patients who had no follow-up

Primary outcomes:
measure: Patient Survival
timeFrame: From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.
Secondary outcomes:
measure: Death-censored Graft Survival
timeFrame: From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.
measure: Graft Function
timeFrame: From the date of kidney transplantation till death or data cut-off, whichever came first, assessed up to 10 years.
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Yitian Fang
state: Zuid Holland
Study officials:
affiliation: Erasmus Medical Center
name: Yitian Fang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06937034: Study on Practical ExperienceS of Treatment With Foslevodopa/foScaRbidopa in Advanced Parkinson's Disease
Official title: Observational Retrospective CoHort Study on Practical ExperienceS of Treatment With Foslevodopa/foScaRbidopa in Advanced Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-04-20
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced Parkinson Disease Patients treated with foslevodopa/foscarbidopa.

Brief summary: Main objective of this study is to describe the evolution of infusion settings (base, high and low infusion rates) of foslevodopa/foscarbidopa subcutaneous infusion (LDp/CDp) at different timepoints in the treatment of advanced Parkinson's disease (aPD) as captured in ONE-CRM.


Eligibility criteria: Inclusion Criteria:

- Diagnosed with levodopa-responsive idiopathic Parkinson's Disease prescribed on LDp/CDp CSCI in routine clinical practice who have consented to be enrolled in the AbbVie Patient Support Program.

Primary outcomes:
measure: Mean Base Infusion Rate
timeFrame: Through end of optimization period (defined as no additional dose modification for at least 15 days since the last dose modification).
measure: Mean Low Infusion Rate
timeFrame: Through end of optimization period (defined as no additional dose modification for at least 15 days since the last dose modification).
measure: Mean High Infusion Rate
timeFrame: Through end of optimization period (defined as no additional dose modification for at least 15 days since the last dose modification).
Secondary outcomes:
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente /ID# 276695
state: Overijssel
city: Timișoara
country: Romania
facility: Universitatea De Medicină Și Farmacie Victor Babeș /ID# 276720
state: Timis
city: Solna
country: Sweden
facility: Karolinska University Hospital Solna /ID# 277116
state: Stockholms Lan
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00667134: Stimulatory Autoantibodies to the Platelet-Derived Growth Factor Receptor (PDGFR) in Patients With Systemic Sclerosis
Official title: Stimulatory Autoantibodies to the PDGFR and Phosphorylation of the PDGFR in Patients With Systemic Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Sclerosis
Keywords: systemic sclerosis autoantibodies
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-04-25
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects from a tertiary care clinic specializing in scleroderma. Controls recruited by subjects being biopsied.

Brief summary: This study is to determine if subjects with .systemic sclerosis have stimulatory autoantibodies to the PDGF receptor and to confirm activation (phosphorylation) of the PDGF receptor in skin sites with varying degrees of skin thickening

Detailed description: Pilot study to assess whether patients with systemic sclerosis have stimulatory autoantibodies to the PDGF receptor and to confirm activation (phosphorylation) of the PDGF receptor in skin sites with varying degrees of skin thickening

Eligibility criteria: Inclusion Criteria:

1. Fulfill the American College of Rheumatology criteria for systemic sclerosis or:
2. Have no diseases that result in primary fibrosis of an organ system, including the skin and do not have an autoimmune disease

Exclusion Criteria:

1. If the subject has systemic sclerosis resulting from an environmental exposure
2. If the subject has an autoimmune disease excluding scleroderma
3. If the subject has an active infection (including, but not limited to hepatitis B, hepatitis C and HIV)
4. If the subject has been treated with cyclophosphamide in the past 8 weeks.
5. If the subject is prone to bleeding because they are on medications that thin the blood or have a low platelet count.

Primary outcomes:
measure: Stimulatory autoantibodies to the PDGF receptor
timeFrame: 1 year
Secondary outcomes:
measure: Phosphorylation of the PDGF receptor in patients with systemic sclerosis
timeFrame: One year
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Medical School
state: Michigan
Study officials:
affiliation: University of Michigan
name: Kristine Phillips, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Julie A Konkle, BSN
role: STUDY_DIRECTOR
References:
Clinical trial NCT02674334: Prospective Evaluation of Cognitive Outcomes After Anesthesia on Patients in the Beach Chair Position
Official title: Prospective Evaluation of Cognitive Outcomes After Anesthesia on Patients in the Beach Chair Position
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury as a Result of Positioning
Keywords: orthopedic procedures
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2016-02-04
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to use Near Infrared Spectroscopy (NIRS) monitoring on participants undergoing shoulder surgery in the beach chair position (BCP) to determine cerebral desaturation events (CDE) and to further determine cognitive changes pre and post surgery using the Mini Mental State Exam.

Detailed description: In this prospective, randomized, controlled study, investigators used a standardized anesthesia protocol to maintain the Mean Arterial Pressure (MAP) during surgeries done in the Beach Chair Position (BCP). Investigators hypothesized that, if the MAP was maintained, Near Infrared Spectroscopy (NIRS) monitoring would not change intra-operative anesthesia management and would not affect the post-operative cognitive outcomes of participants undergoing surgery in the beach chair position. Investigators secondarily wanted to document the actual incidence of cerebral desaturation events (CDEs) recorded by NIRS occurring in participants placed in the BCP if the MAP was strictly maintained.

Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* elective shoulder surgery in the beach chair position

Exclusion Criteria:

* less than 18 years of age
* preoperative score of 23 or less on the pre-operative Mini Mental State Exam
* traumatic brain injury
* transient ischemic attack
* cerebrovascular incident
* any apparent clinical neurologic dysfunction
* carotid artery stenosis
* known vascular malformation in head
* inability to have blood pressure measured in the opposite extremity
* malignant hyperthermia

Primary outcomes:
measure: Percentage of Participants With 20+% Cerebral Desaturation Events
timeFrame: one day
Secondary outcomes:
measure: Change in Mini Mental State Exam (MMSE) > 2 or a Score of 23 up to Two Weeks After Surgery Minus Baseline Value
timeFrame: baseline and up to two weeks
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: West Virginia University
name: George K Bal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01942434: Fatty Acid Levels and Memory in Breastfed Children
Official title: The Influence of FADS2 rs 174575 on Breastmilk Fatty Acid Levels and the Recognition Memory Abilities of 6-month Old Breastfed Infants and Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Development
Keywords: Fatty acids
Breast milk nutrients
Cognitive development
Electrophysiology
Long-term assessment
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2013-09-16
Enrollment: 202
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breastfeeding infants and their mothers

Brief summary: Purpose: To explore the relation between breastmilk nutrients and the cognitive abilities of breastfed infants.

Phase 1: Near 3 months of age child and mother saliva samples for DNA obtained with breast milk sample.

Phase 2: At 6 months of age child participates in electrophysiology session to test recognition memory.

Phase 3: At 26 or 38 months of age, children will complete behavioral, dietary, and physical assessments.


Eligibility criteria: Inclusion Criteria:

* typically-developing
* exclusively breastfed
* unremarkable delivery

Exclusion Criteria:

* non-English speaking
* history of seizure activity

Primary outcomes:
measure: Relation between recognition memory and maternal FADS genotype
timeFrame: 6 months
Secondary outcomes:
measure: Nutrient content of breastmilk as it relates to FADS genotype
timeFrame: 3 to 4 months
measure: Nutrient content of breastmilk as it relates to recognition memory
timeFrame: 6 months
measure: Relation between declarative memory and breastmilk nutrients
timeFrame: 26 or 38 months
measure: Relation between declarative memory and concurrent nutrients
timeFrame: 26 or 38 months
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: Nutrition Research Institute
state: North Carolina
Study officials:
affiliation: UNC at Chapel Hill
name: Carol L Cheatham, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00421317: Imatinib in Adult Patients With Metastatic Ocular Melanoma
Official title: A Phase II Multicentric Trial to Assess Efficacy and Toxicity of Imatinib in Adult Patients With Metastatic Ocular Melanoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Melanoma
Keywords: Ocular, Metastatic melanoma
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Novartis
name: National Cancer Institute, France
First posted: 2007-01-11
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The scope of the trial is to determinate the anti-tumoral activity of imatinib in metastatic ocular melanoma patients.

Detailed description: Further study details as provided by Centre Oscar Lambret

Eligibility criteria: Inclusion Criteria:

* Metastatic ocular melanoma
* Age \> or = 18 years old
* Measurable metastases \> or = 10 mm according to RECIST criteria
* PS-WHO \< or = 1 or IK \> 70 percent
* Normal hepatic function
* PNN \> 1500/mm3, platelets \> or = 100 000/mm3
* Contraception
* Informed consent signed

Exclusion Criteria:

* Patient with two prior lines of systemic treatment (chemotherapy, immunotherapy or association)
* Other evolutive neoplasic disease
* Severe hepatic insufficiency
* Severe renal insufficiency
* Somatic or psychiatric co-morbidity incompatible with the protocol
* Leptomeningeal or cerebral metastatic dissemination
* Pregnant or lactating woman
* Other antitumoral treatment
* Patient participating to another clinical trial with an experimental drug
* Known hypersensitivity to Imatinib or one of its excipients
* Resecable single metastasis

Primary outcomes:
measure: Progression-free rate at 3 months
Secondary outcomes:
measure: Progression-free rate at 6 and 12 months
measure: Response rate according to RECIST criteria
measure: Toxicity
measure: Global survival,Progression-free survival
measure: Predictive genomic factors of response
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre Francois Baclesse
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre Georges-Francois Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lille
country: France
facility: Centre Hospitalier Regional Universitaire
city: Lyon
country: France
facility: Centre Leon Berard
city: Montpellier
country: France
facility: Centre Val d'Aurelle Paul Lamarque
city: Paris
country: France
facility: Institut Curie
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Strasbourg
country: France
facility: Hopital Universitaire de Hautepierre
city: Toulouse
country: France
facility: Institut Claudius Regaud
city: Villejuif
country: France
facility: Centre Gustave Roussy
Study officials:
affiliation: Centre Oscar Lambret
name: PENEL Nicolas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02147717: Laser Acupuncture and Pain Management in Preterm Infants Undergoing Patent Ductus Arteriosus Ligation
Official title: Laser Acupuncture and Pain Management in Preterm Infants Undergoing Patent Ductus Arteriosus Ligation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Newborns
Keywords: preterm newborns
Transfontanellar ultrafast doppler
Acupuncture
perioperative pain
surgery of the ductus arteriosus
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-05-28
Enrollment: 40
Sex: ALL
Minimum age (years): 24
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prospective study, controlled, randomized, single-center, blinded, which aims to evaluate the effect of laser acupuncture in the treatment of perioperative pain during tracheal suction after patent ductus arteriosus ligation in preterm infants.

Detailed description: management of pain in preterm infants is essential because it is exposed to repetitive movements painful and invasive miners such as surgical treatment of the ductus arteriosus which is accompanied by respiratory instability, increased consumption analgesics. Acupuncture has shown its analgesic efficacy in numerous studies in children and adults. Acupuncture (laser) is a simple, fast method without side effect used in children, but no study exists on the effect of acupuncture in the treatment of perioperative pain in addition to pharmacologic agents in preterm infants. Hypothesis: acupuncture reduce pain and discomfort after surgery of the ductus arteriosus in preterm infants in addition to pharmacologic agents

Main objective:

Assessing the contribution of laser acupuncture on the pain management during endotracheal suctioning (ETS) after surgery ductus arteriosus in preterm infants

Eligibility criteria: Inclusion Criteria:

* Preterm infant born between 24 +0 and 32 +6 j GA
* Ductus arteriosus surgery scheduled in Robert Debré hospital
* Informed consent of the holders of the exercise of parental authority
* Child beneficiary of a social security scheme (excluding AME)

Exclusion Criteria:

* Obvious underlying disease (genetic, metabolic)

Primary outcomes:
measure: Behavioral pain scale (COMFORT scale)
timeFrame: 48 hours post-operative
Secondary outcomes:
measure: Behavioral pain scale (DAN scale and EDIN scale)
timeFrame: 48hours postoperative
measure: Consumption of morphine
timeFrame: 48 hours postoperative
measure: Measurement of FIO2
timeFrame: 48 hours postoperative
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Robert Debré
Study officials:
affiliation: APHP
name: Biran Valérie, PHD
role: PRINCIPAL_INVESTIGATOR
References: