louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02083705: Chest Compression and Sustained Inflation
Official title: Chest Compression and Sustained Inflation for Asystole or Bradycardia in Newborn Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn Infants Having Asystole or Bradycardia at Birth
Keywords: Chest compression, Delivery Room, NICU,
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 9
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Guidelines on neonatal resuscitation recommend 90 chest compressions (CC) and 30 manual inflations (3:1) per minute in newborns. The study aimed to determine if CC s during sustained inflations (SI) improves recovery of asphyxiated newborns compared to coordinated 3:1 resuscitation.


Eligibility criteria: Inclusion Criteria:

Newborn infants with asystole Newborn infants with bradycardia

Exclusion Criteria:

-

Primary outcomes:
measure: Time Needed to Achieve Return of Spontaneous Circulation
timeFrame: within the first 10 minutes after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Georg Schmolzer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmolzer GM, O Reilly M, Fray C, van Os S, Cheung PY. Chest compression during sustained inflation versus 3:1 chest compression:ventilation ratio during neonatal cardiopulmonary resuscitation: a randomised feasibility trial. Arch Dis Child Fetal Neonatal Ed. 2018 Sep;103(5):F455-F460. doi: 10.1136/archdischild-2017-313037. Epub 2017 Oct 7.
Clinical trial NCT02642705: High Intensity Interval Training and Hypoxic Conditioning in Obese Patients
Official title: New Treatment Modalities in Obese Patients: High Intensity Interval Training and Hypoxic Conditioning
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aims at evaluating the effect of two innovative treatment strategies in obese patients: high intensity interval training and hypoxic conditioning. Obese patients will be randomized in groups performing high intensity interval training, constant load training, hypoxic conditioning or placebo normoxic conditioning for 8 weeks. The effects of the interventions will be measured regarding exercise tolerance, blood pressure, body composition, metabolic status.

Detailed description: 120 obese patients will be randomized to 6 intervention groups. Each group will follow an 8-week intervention (3 session per week) with either high intensity interval training in normoxia or hypoxia, constant load exercise training in normoxia or hypoxia, hypoxic or normoxic (placebo) conditioning at rest. Exercise capacity, metabolic status, blood pressure, vascular function and physical activity will be assessed before and after the intervention.

Eligibility criteria: Inclusion Criteria:

* BMI between 27 and 35 kg/m²
* Physical activity \<2 hours/week
* No chronic disease or treatment able to interfere with inflammation and metabolic perturbatiosn associated with obesity

Exclusion Criteria:

* Diabetes mellitus treated with insulin
* Auto-immune or inflammatory diseases requiring long term therapy
* Unstable dysthyroidism
* Bariatric surgery within the past 18 months
* Tumoral, inflammatory, infectious, cardiac, respiratory, kidney, digestive disease
* Untreated sleep apnea

Primary outcomes:
measure: Maximal exercise capacity
timeFrame: 8 weeks
Secondary outcomes:
measure: Metabolic status
timeFrame: 8 weeks
measure: Body composition
timeFrame: 8 weeks
measure: Blood pressure
timeFrame: 8 weeks
measure: Vascular function
timeFrame: 8 weeks
measure: Physical activity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University Hospital
state: Rhone Alpes
Study officials:
affiliation: University Hospital, Grenoble
name: Bernard Wuyam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verges S, Chacaroun S, Godin-Ribuot D, Baillieul S. Hypoxic Conditioning as a New Therapeutic Modality. Front Pediatr. 2015 Jun 22;3:58. doi: 10.3389/fped.2015.00058. eCollection 2015.
citation: Weston KS, Wisloff U, Coombes JS. High-intensity interval training in patients with lifestyle-induced cardiometabolic disease: a systematic review and meta-analysis. Br J Sports Med. 2014 Aug;48(16):1227-34. doi: 10.1136/bjsports-2013-092576. Epub 2013 Oct 21.
Clinical trial NCT03954405: Multi-marker Approach for Risk Assessment in PAH
Official title: Multi-marker Approach for Risk Assessment in Pulmonary Arterial Hypertension (PAH)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Wuhan Asia Heart Hospital
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients with diagnosis of PAH from groups I

Brief summary: Prospective registry including incident patients and prevalent patients which pretends to identify clinical characteristics, treatment trends in-hospital and ten years follow-up outcome through major adverse cardiovascular events (MACE) in a China population with well characterized PAH.

Detailed description: baseline include: An echocardiogram to assess the size, shape, pumping action and the extent of any damage to the heart.

Lung function tests which include blowing measurements to assess gas volumes within the lungs as well as assessment of how the lungs exchange gases.

Right heart catheterisation (RHC) to diagnose PAH Optional Cardiac Magnetic Resonance tests. 6 minute walk distance (6MWD). To measure exercise capacity Electrocardiogram (ECG), a test that measures the electrical activity of the heart Blood tests

MACE include:

death heart/lung transplantation atrial septostomy hospitalization due to worsening of PAH start of new specific PAH treatment persistent decrease of \>15% from baseline in 6MWD (or \>30% compared with last study-related measurement) persistent worsening of World Health Organization (WHO) Functional Class (FC）

Eligibility criteria: Inclusion Criteria:

diagnosis of PAH (by RHC)

Exclusion Criteria:

Refusal to participate.

Primary outcomes:
measure: survival
timeFrame: 5 years
Secondary outcomes:
measure: clinical worsening
timeFrame: 5 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Asian Heart Hospital
Study officials:
affiliation: Wuhan Asian Heart Hospital
name: Qiu Qiu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02675205: Ticagrelor vs Clopidogrel for Platelet Inhibition in Stenting for Cerebral Aneurysm
Official title: Ticagrelor Versus Clopidogrel for Platelet Inhibition in Patients Undergoing Neurovascular Stenting for Intracranial Aneurysm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebral Aneurysm
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-02-05
Enrollment: 100
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: Part of interventional neuroradiology procedures for the treatment of selected cerebral aneurysms are now based on stenting. To reduce thromboembolic events, dual antiplatelet therapy (APT) combining aspirin and clopidogrel is proposed with close monitoring, since 1/3 of the patients are low responders due to variation of the biological response to clopidogrel . Ticagrelor is used by few teams but has never been evaluated in a randomized controlled trial. It could be an option for APT due to more reproducible response with less interindividual variability and reduced monitoring. The aim of this study is to demonstrate the interest of ticagrelor for the dual APT for platelet inhibition, in patients undergoing neurovascular stenting for cerebral aneurysm.


Eligibility criteria: Inclusion Criteria:

* unruptured cerebral aneurysm
* elective endovascular treatment
* stenting required
* dual antiplatelet therapy required

Exclusion Criteria:

-none

Primary outcomes:
measure: proportion of patients requiring at least one change of drug or dose adjustment to achieve platlet functional inhibition
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
References:
Clinical trial NCT05163405: Perspectives of Subcutaneous Velcade at Home of Patients With Myeloma.
Official title: Perspectives of Subcutaneous Velcade at Home of Patients With Myeloma.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Multiple Myeloma in treatment with Velcade in Department of Hematology X, outpatient clinic, at Odense University Hospital.

Brief summary: In the present study, we have trained 10 patients in subcutaneous self-administration of Velcade. After their training, patients will alternately receive their treatment in the hospital and at home by self-administration. In keeping with common practice, a nurse contacts the patients by telephone before 9.00 am on the day of treatment to ensure that the patient is physically "fit" to receive the medication and to discuss any side effects. To highlight the advantages and disadvantages of the changed treatment practice from the perspectives of both patients and healthcare professionals, data is collected from two consecutive semi-structured interviews with n = 10 patients and n = 1 focus group interview of the healthcare professionals involved. Moreover, time registration of medication administration both at the hospital and in the patients' home is done. The qualitative data will be analyzed via the method of condensation and continual quantitative data will form the basis of a cost-benefit analysis.


Eligibility criteria: Inclusion criteria

* Patients must have Multiple Myeloma
* Patients (or their relatives) must be deemed physically and cognitively suitable and willing for self-administration of subcutaneous Velcade
* Patients must be able to understand and speak Danish
* Patients must have received a minimum of 1 treatment cycle in the outpatient clinic

Exclusion criteria

* Lack of willingness to participate in scheduled interviews
* Patients who are cognitively affected
* Must not be receiving trial treatment

Primary outcomes:
measure: Patients experience of self-administration of Velcade
timeFrame: Through study completion, from 01. dec. 2019 until 01. jun. 2022
Secondary outcomes:
measure: Organizational perspective
timeFrame: Through study completion, from 01. dec. 2019 until 01. jun. 2022
measure: Health care perspective
timeFrame: Through study completion, from 01. dec. 2019 until 01. jun. 2022
measure: Financial perspective
timeFrame: Through study completion, from 01. dec. 2019 until 01. jun. 2022
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital. Department of Oncology.
name: Karin Brochstedt Dieperink, RN
role: STUDY_DIRECTOR
References:
Clinical trial NCT03091205: Proper Extent of Maze Intercaval Lesion
Official title: Proper Extent of Maze Intercaval Lesion
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Atrial Fibrillation
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 0
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 scheduled for any cardiac surgery where visualization and mapping of cavo-atrial junction is possible

Brief summary: It's hypothesized that a mean and range distance from the cavo-atrial junction to the area where there is complete loss of conductive tissue can be measured to better inform surgeons performing the Cox-Maze procedure. A patient scheduled for any cardiac surgery where visualization and mapping of cavo-atrial junction is possible could be entered into the study if they meet the inclusion/exclusion requirements.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years male or female
* Scheduled for any cardiac surgery where visualization and mapping of cavo-atrial junction is possible
* Subjects willing and able to provide written informed consent

Exclusion Criteria:

* Subjects receiving surgery with non-sternotomy access
* Presence of or history of transvenous pacing leads
* Subjects receiving a re-do cardiac surgery
* Subjects with a history of pericarditis
* Subjects who are in atrial fibrillation or atrial flutter and cannot be converted out of it.
* Any medical condition or finding for which the Investigator used medical discretion to determine the subject should be excluded
* Subject is currently participating in another clinical trial.
* Subject is unable to provide written informed consent.

Primary outcomes:
measure: Distance until complete loss of conductive tissue
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
Study officials:
affiliation: Baylor Reasearch Institute
name: Timothy George, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04344405: Vitamin D as a Key Player in Rheumatoid Arthritis
Official title: Vitamin D as a Key Player in Rheumatoid Arthritis Immune Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: the Immunomodulatory Effect
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rheumatoid arthritis (RA) is a systemic, chronic and inflammatory disease of joints linked to autoimmunity. Vitamin D was found to modulate cell growth, function of immune cells and anti-inflammatory action. The aim of this study was to investigate serum vitamin D level and some cytokines and to identify the correlation between vitamin D and these cytokines in RA.

Methods: Totally 60 RA patients without vitamin D supplement were involved in this study. The serum level of vitamin D, interleukin-6 (IL-6), IL-10, IL-35, tumor necrosis factor α (TNF-α) and C-reactive protein (CRP) were measure in all patients by enzyme-linked immunosorbent assay (ELISA) then they will divided into 2 groups, group I receive vit. D supplementation and group II will receive placebo and follow up for 3 months.

Detailed description: Rheumatoid arthritis (RA) is a systemic, chronic and inflammatory disease of joints linked to autoimmunity. Vitamin D was found to modulate cell growth, function of immune cells and anti-inflammatory action. The aim of this study was to investigate serum vitamin D level and some cytokines and to identify the correlation between vitamin D and these cytokines in RA.

Methods: Totally 60 RA patients without vitamin D supplement were involved in this study. The serum level of vitamin D, interleukin-6 (IL-6), IL-10, IL-35, tumor necrosis factor α (TNF-α) and C-reactive protein (CRP) were measure in all patients by enzyme-linked immunosorbent assay (ELISA) then they will divided into 2 groups, group I receive vit. D supplementation and group II will receive placebo and follow up for 3 months.

Eligibility criteria: Inclusion Criteria:

* RA patients

Exclusion Criteria:

* Patients with inflammatory bowel disease patients with any other autoimmune diseases

Primary outcomes:
measure: disease activity score 28
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Manal Hassanien
state: Assuit
Study officials:
References:
Clinical trial NCT02008305: Comparison of Two Protocols of Optimization of X Ray Radiations in Pediatric Interventional Neuroradiology
Official title: Comparison of Two Protocols of Optimization of X Ray Radiations in Pediatric Interventional Neuroradiology
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Occlusion or Malformation of a Cerebral Vessel
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2013-12-11
Enrollment: 2
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Interventional Neuroradiology replaces surgery. This technology requires various exposition to X rays : number of X rays photographs, radioscopy, distance between patient and detector, speed of acquisition of X-rays photographs, high tension and intensity.

The manipulator must find the right balance between quality of photographs and dose delivered to the patient (optimization).

Children are particularly exposed to these risks of irradiation (sensitivity to X-rays and long life expectancy with risks. So, it is fundamental to optimize the dose delivered during the procedures.

The investigators propose to analyse a study comparing two protocols of optimization of doses. The investigators' hypothesis is that the protocol experimented in this trial allows less radiation of the children, compared to the usual protocol.


Eligibility criteria: Inclusion Criteria:

* malformation or occlusion of a cerebral vessel requiring interventional Neuroradiology

Exclusion Criteria:

* opposition ot the parent(s) to the participation of their child in the trial and/or no social security.

Primary outcomes:
measure: Comparison of the average dose per child, according to the protocol
timeFrame: maximum one day per patient
Secondary outcomes:
measure: number of X-rays photographs according to the protocol, quality of photographs according to the protocol,
timeFrame: maximum one day per patient
Other outcomes:
measure: number of interrupted dosing
timeFrame: one day per patient
Locations:
city: Paris
country: France
facility: Fondation ophtalmique Adolphe de Rothschild
Study officials:
affiliation: Fondation Ophtalmologique Adolphe de Rothschild
name: Michel Piotin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005105: Genetic Study of Insulin-Like Growth Factor-I Receptor Mutations in Patients With Intrauterine Growth Retardation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intrauterine Growth Retardation
Keywords: endocrine disorders
intrauterine growth retardation
rare disease
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Children's Hospital Medical Center, Cincinnati
First posted: 2000-04-07
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES:

I. Determine if mutations in the gene encoding the insulin-like growth factor-I receptor lead to relative insulin-like growth factor-I insensitivity and produce intrauterine growth retardation in children.

Detailed description: PROTOCOL OUTLINE:

Patients undergo blood draw. Insulin-like growth factor-I (IGF-I) and insulin-like growth factor binding protein-3 (IGFBP-3) are measured. Patients whose IGF-I and IGFBP-3 levels are average or above are tested for the presence of mutation in the insulin-like growth factor-I receptor.

Eligibility criteria: * Intrauterine growth retardation (IUGR), defined as birth weight less than 2 standard deviations below the mean by Usher and McLean Deficient "catch-up" growth (stature less than 5th percentile on growth chart after age 18 months) Normal or elevated circulating concentrations of insulin-like growth factor-I (IGF-I) and insulin-like growth factor binding protein-3 (IGFBP-3) IGF-I or IGFBP-3 within or above the 95th percentile confidence interval for age No other clinical explanation for poor prenatal and postnatal growth No IUGR due to maternal toxemia, endocrine disease, gastrointestinal disease, significant heart disease, or chromosomal abnormalities No other condition known to retard growth

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Indianapolis
country: United States
facility: James Whitcomb Riley Hospital for Children
state: Indiana
city: New Hyde Park
country: United States
facility: Schneider Children's Hospital
state: New York
city: Cincinnati
country: United States
facility: Children's Hospital Medical Center - Cincinnati
state: Ohio
city: Richmond
country: United States
facility: Medical College of Virginia School of Medicine
state: Virginia
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Steven D. Chernausek
role: STUDY_CHAIR
References: