louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01101620: Effect of Levosimendan on Respiratory Muscle Function in Healthy Subjects
Official title: Pilot Study on the Effects of Levosimendan on in Vivo Respiratory Muscle Function in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Muscle Function
Lead sponsor: University Medical Center Nijmegen
Sponsor class: OTHER
Collaborators: name: Orion Corporation, Orion Pharma
First posted: 2010-04-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate if levosimendan improves contractile performance of the diaphragm in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* informed consent

Exclusion Criteria:

* use of any prescript medication
* chronic hiccups
* pre-existent muscle disease (congenital or acquired) or diseases / disorders know to be associated with myopathy including diabetes and auto-immune diseases.
* pre-existent lung disease
* pre-existent cardiac disease (based on history, electrocardiography and transthoracic echocardiography)
* pregnancy, breast feeding
* upper airway / esophageal pathology
* phrenic nerve lesions
* any metals in body (pacemaker, splinters, metal stiches)

Primary outcomes:
measure: Contractility of the diaphragm elicited with magnetic stimulation of the phrenic nerves
timeFrame: Multiple measurements within 4 hours after administration of study medication
measure: Fatiguability of the diaphragm
timeFrame: Multiple measurements within 4 hours after administration of study medication
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: University Medical Center Nijmegen
state: Gelderland
Study officials:
affiliation: University Medical Center Nijmegen
name: Leo Heunks, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Nijmegen
name: Jonne Doorduin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03927820: A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
Official title: A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COPD
Asthma
Keywords: inhaler
pharmacy
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 914
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to assess the impact of pharmacist-led benefits investigations and application of clinical practice guidelines on patient access to inhalers and time to hospital readmission or Emergency Department (ED) visit.


Eligibility criteria: Inclusion Criteria:

* Adult patient admitted to Vanderbilt University Medical Center (VUMC) (excluding surgery services)
* on a long acting inhaler or prescribed a long acting inhaler during admission.

Exclusion Criteria:

* Diagnosis of cystic fibrosis
* Diagnosis of graft versus host disease (GVHD)
* no medication insurance
* discharge to any post-acute care facility or inpatient hospice
* death during hospitalization

Primary outcomes:
measure: Time to either hospital readmission or ER visit
timeFrame: 6 months
Secondary outcomes:
measure: Frequency of ED visit
timeFrame: 6 months
measure: frequency of hospital readmissions
timeFrame: 6 months
measure: time to 1st ED visit (days)
timeFrame: 6 months
measure: time to 1st readmission (days)
timeFrame: 6 months
measure: frequency of prescribed inhaler at discharge
timeFrame: 6 months
measure: frequency of short course prescription of oral steroid
timeFrame: 6 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt Univeristy Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Kristina Niehoff, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04986020: Identifying New Biomarkers of Parkinson's From Routine Brain Imaging
Official title: Identifying New Biomarkers of Parkinson's From Routine Brain Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Lead sponsor: University of Plymouth
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants drawn from the catchment areas of participating healthcare organisations

Brief summary: The study will use routine computer tomography (CT), magnetic resonance spectroscopy (MRI) and nuclear medicine (NM) brain imaging data to produce new diagnostic tests for the onset of Parkinson's disease. This will enable hopefully earlier diagnosis than is currently possible. This will entail the analysis of anonymised CT/MRI/NM brain images collected prior to the point when these subjects were diagnosed with PD.

Detailed description: We intend to use historical CT/MRI/nuclear medicine brain scans to identify novel imaging biomarkers of prodromal Parkinson's disease. The primary data source for the study will be MRI and CT brain scans, whilst nuclear medicine imaging brain imaging (DAT scans) will be used to validate models produced and provide a functional outcome measure of brain dopamine uptake. We shall utilise a an artificial intelligence approach to compare scans of PD cases with matched controls in order to identify these imaging biomarkers.

A list of participants with a diagnosis will be compiled. This list, together with relevant clinical data, will be linked with historical CT/MRI/nuclear medicine scans carried out over the preceding years. A control group of matched non-PD scans will also be compiled.

The dataset will be anonymised and a bespoke ML pipeline will be used to identify imaging featureswhich may be indicative of prodromal PD. This initial stage will be carried out at University Hospital Plymouth NHS Trust (UHPNT), the Royal Cornwall Hospital NHS Trust (RCHNT) and Cornwall Partnership NHS Trust (CPNT). If successful, findings will be validated in a larger sample of scans compiled from hospitals regionally and nationally.

Eligibility criteria: Inclusion Criteria:

- A clinical diagnosis of Parkinson's

Exclusion Criteria:

- No clinical diagnosis of Parkinson's

Primary outcomes:
measure: The presence of novel putative biomarkers of future PD development as defined by a deep-learning method
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02890420: Nutritional Status Of Under-Six Children: Epidemiology Study (NUTRI-STAT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children Behavior About Nutrition
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 262
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children in third year of preschool in one of the 16 schools in Thionville, Lorraine, FRANCE

Brief summary: This study permit to evaluate the characteristics of children in third year of preschool, during a year, in 16 schools in Thionville (north-eastern France) by the way of the annual medical visit.The aim of the study is to describe the nutritional status of children under-six years of age: underweight, overweight, and obesity considering the sex. .

Detailed description: For several decades the eating behavior has been changing. That note is obviously more true for children, with the arrival of new recipes, not really healthier for all. This study permit to evaluate the characteristics of children in third year of preschool, during a year, in 16 schools in Thionville (north-eastern France) by the way of the annual medical visit. The aim of the research is to estimate the healthy weight corresponding with a height considering the gender.

Eligibility criteria: Inclusion Criteria:

* third year of preschool in Thionville
* information of the legal responsibles

Exclusion Criteria:

* opposition of the legal responsible for gathering data

Primary outcomes:
measure: Body mass index of children
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHR Metz-Thionville
name: Pierre CUNY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01170520: Repetitive Transcranial Stimulation (rTMS) for Resistant Depression in Adolescents
Official title: The Addition of rTMS to the Therapy of Adolescents That Suffer From Treatment Resistant Depression: An Open Label Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Adolescent Depression
Keywords: adolescent resistant depression
repetitive transcranial magnetic stimulation
treatment of resistant adolescent depression
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2010-07-27
Enrollment: 24
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators hypothesis that repetitive transcranial Stimulation (rTMS) is a safe and effective add-on therapy for resistent depression in adolescent patients.

A group of adolescents suffering from non psychotic major depression that was resistant to at least 2 drug trials and a trail of psychotherapy will be recruited. After an informed consent procedure for both parents and patients, patients will go through a clinical and cognitive evaluation. They will receive a protocol of 4 weeks (20 work days) of rTMS using the figure of 8 magstim coil at 100% threshold, 42 trains of 4 seconds each, intertrain interval of 30 sec to the LDPC, 1680 pulses per day. Then they will be reevaluated.


Eligibility criteria: Inclusion Criteria:

* Age 15-18 years old
* Right hand dominant
* Suffering from major depression
* CDRS \> 60
* At least 3 months of current depressive episode
* Failed 2 drug trials (or 3 drug trials if trial terminated prematurely due to side effects) and at least 1 course of psychotherapy
* No contraindication for rtms (safety questionnaire)
* No change in pharmacotherapy in the last month

Exclusion Criteria:

* Schizophrenia or psychotic symptoms
* Hypertension
* Epilepsy
* History of major head trauma
* Metal implements in the head
* History of neurosurgery
* History of severe head migraine
* History of hearing loss or sp cochlear transplantation
* Pregnancy
* Current drug abuse
* Unstable medical condition
* History of manic episode
* Current treatment with lithium or tricyclic or tetracyclic antidepressants

Primary outcomes:
measure: Child Depression Rating Scale (CDRS) comparison before after therapy
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hod Hasharon
country: Israel
facility: Shalvata Mental health Center
city: Hod Hasharon
country: Israel
facility: Shalvata Mental Health Center
Study officials:
References:
Clinical trial NCT02469220: Diet Treatment of Patients With Ulcerative Colitis in Remission
Official title: Diet Treatment of Patients With Ulcerative Colitis in Remission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Keywords: Diet
low FODMAP
UC
IBS
Lead sponsor: Regionshospital Nordjylland
Sponsor class: OTHER_GOV
First posted: 2015-06-11
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study examines the effect of a low FODMAP diet in patients with UC in remission but still having GI symptoms (IBS in IBD). 15 patients will be on watchful waiting. 15 patients will be on low FODMAP diet. 15 patients with recieve FODMAPs in their diet.

Detailed description: Patients are randomized to either standard care, low FODMAP diet or a normal FODMAP diet. Run-in on a low FODMAP diet, thereafter parallel design where one arm is assign a blinded food supplement with low FODMAP content and the other arm is assigned a blinded food supplement containing FODMAP. A control group is "watchful waiting".

Symptom reports, blood, and fecal samples are collected.

Eligibility criteria: Inclusion Criteria:

* Colitis ulcerosa in remission (calciprotectin\<200 and normal sigmoidoscopy)
* ROM IV criteria fullfilled
* Stable medical therapy

Exclusion Criteria:

* Intake of a low FODMAP diet within the past 6 weeks prior to baseline
* Atypical colitis ulcerosa primarily right sided disease and calciprotectin \>50 unless normal sigmoidoscopy
* If diarrhea: Clostridium difficile infection
* Lactose intolerance
* Systemisk or local treatment for CU other than 5-aminosalicylicacid or biological therapy
* Antibiotics within 6 weeks
* Pregnancy
* Activity in UC
* Coeliac disease
* Abnormal transglutaminase
* Eating disorder
* Special diet preventing the low FODMAP diet
* Other GI disease or other disease explaining symptoms
* Medication intake explaining symptoms
* Not able to follow protocol

Primary outcomes:
measure: Gastrointestinal symptoms
timeFrame: Week 8
Secondary outcomes:
measure: Change in Quality of life
timeFrame: Week 8
measure: Pain diary
timeFrame: Daily during the study
Other outcomes:
Locations:
city: Hjørring
country: Denmark
facility: North Denmark Regional Hospital
state: Nordjylland
Study officials:
affiliation: Regionshospital Nordjylland
name: Anne L Krarup, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Regionshospital Nordjylland
name: Jeanette Soerensen, PhD-student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06306820: Ultrasound Guided Recruitment Manauvere Versus Individualized Positive End Expiratory Pressure in Pediatric Patients Undergoing Laparoscopic Abdominal Surgery
Official title: Ultrasound Guided Recruitment Manauvere Versus Individualized Positive End Expiratory Pressure in Pediatric Patients Undergoing Laparoscopic Abdominal Surgery; A Prospective Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ultrasound Guided Recruitment Manauvere
End Expiratory Pressure
Pediatric Patients
Laparoscopic Abdominal Surgery
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this prospective randomized controlled study is to compare the effect of US-guided Recruitment Manauvere (RM) versus individualized positive end-expiratory pressure (PEEP) on oxygenation and preventing respiratory complications in pediatric patients undergoing laparoscopic abdominal surgeries.

Detailed description: Atelectasis is among the most frequent postoperative pulmonary complications (PPCs) of general anesthesia with an incidence of between 68% and 100% in children. Atelectasis impairs gas exchange, thus causing hypoxemia and other respiratory disorders such as acute lung injury and pneumonia.

Pneumoperitoneum is another risk factor for perioperative atelectasis. It elevates the diaphragm and intra-abdominal pressure. In order to prevent atelectasis, applying positive end-expiratory pressure (PEEP) or an alveolar recruitment Maneuvere (RM) have shown beneficial effects.

Lung ultrasound (US) is a noninvasive, radiation-free, convenient, and reproducible bedside imaging modality for anesthesia-induced atelectasis in children.

Eligibility criteria: Inclusion Criteria:

* Age from 3 to 8 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I-II.
* Children scheduled for elective laparoscopic abdominal surgeries.

Exclusion Criteria:

* Parental refusal.
* Bronchial asthma or any preexisting chest disease.
* Congenital deformity of the thoracic cage.
* Patients with a history of thoracic surgery.
* Cardiac, hepatic, or renal failure.
* Obese children with BMI at or above 95th percentile of the same age and sex.

Primary outcomes:
measure: Intraoperative oxygenation
timeFrame: One hour after second recruitment Maneuvere
Secondary outcomes:
measure: Lung ultrasound scores
timeFrame: 24 hours after extubation
measure: Mean arterial blood pressure (MAP)
timeFrame: One hour after extubation
measure: Heart rate
timeFrame: One hour after extubation
measure: Postoperative pulmonary complication
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT01490320: The Effect of Primary Care Interventions on Children's Media Viewing Habits and Exposure to Violence
Official title: The Effect of Primary Care Interventions on Children's Media Viewing Habits and Exposure to Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Violence
Keywords: Violence prevention
Media
Primary care
Parenting
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2011-12-12
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The American Academy of Pediatrics recommends that parents receive anticipatory guidance about violence prevention as part of the routine well child visit. Educational resources are needed to help physicians routinely provide these important anticipatory guidance messages. In this study, consecutive parents will be exposed to routine anticipatory guidance messages before the well child visit with the physician. After the clinic visit, parents will be invited to participate in a research study to determine if they plan any changes at home. The key research question of this study is:

Can a brief multimedia program (i.e. Play Nicely program) and/or the AAP Connected Kids brochure, entitled, "Pulling the Plug on TV Violence", help parents develop plans to decreases their children's exposure to violence in the media (e.g. less media time, no TV in the bedroom)?


Eligibility criteria: Inclusion Criteria:

* Participants included English and Spanish speaking caregivers of 2-12 year old children presenting to the pediatric primary care clinic for a well-child visit.

Exclusion Criteria:

* Parents who could not speak either English or Spanish.

Primary outcomes:
measure: Changes in media viewing habits
timeFrame: Baseline and 2-4 weeks
measure: Changes in exposure to violence.
timeFrame: Baseline and 2-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Pediatric Primary Care Clinic
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Seth J Scholer, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scholer SJ, Hudnut-Beumler J, Dietrich MS. The effect of physician--parent discussions and a brief intervention on caregivers' plan to discipline: is it time for a new approach? Clin Pediatr (Phila). 2011 Aug;50(8):712-9. doi: 10.1177/0009922811400730. Epub 2011 Mar 10.
citation: Scholer SJ, Hudnut-Beumler J, Dietrich MS. A brief primary care intervention helps parents develop plans to discipline. Pediatrics. 2010 Feb;125(2):e242-9. doi: 10.1542/peds.2009-0874. Epub 2010 Jan 18.
Clinical trial NCT01327820: Study of Post-operative Oxygen Consumption Following Vascular Surgery
Official title: Study of Post-operative Oxygen Consumption Following Vascular Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxygen Consumption
Aortic Aneurysm
Peripheral Arterial Disease
Keywords: Oxygen consumption
Aortic Aneurysm
Peripheral Arterial Disease
Lead sponsor: NHS Lothian
Sponsor class: OTHER_GOV
First posted: 2011-04-04
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting for major vascular surgery at the Royal Infirmary of Edinburgh

Brief summary: To define any changes in whole body oxygen consumption that occur following major vascular surgery (open aortic aneurysm surgery; endovascular aortic aneurysm repair; and infra-inguinal lower limb revascularisation procedures).


Eligibility criteria: Inclusion Criteria:

* Patients presenting for major vascular surgery at the Royal Infirmary of Edinburgh

Exclusion Criteria:

* Patient refusal

Primary outcomes:
measure: Whole body oxygen consumption
timeFrame: post-operative day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
Study officials:
References: