louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03833635: Effects of OMT on Premature Physiological Parameters
Official title: Effects of OMT on Premature Physiological Parameters: a RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Infant
Physiological Stress
Lead sponsor: Come Collaboration
Sponsor class: OTHER
Collaborators: name: Vittore Buzzi Children's Hospital
First posted: 2019-02-07
Enrollment: 100
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteopathic manipulative treatment has been showed to reduce LOS in premature infants. Despite the clinical effectiveness, lack of data and information on the physiological underpinning effects during the treatment has been revealed. The aim of the study is to explore the immediate physiological effects of osteopathic treatment on premature infants


Eligibility criteria: Inclusion Criteria:

* preterm infants

Exclusion Criteria:

* congenital/genetic disease
* cardiovascular/neurological disease

Primary outcomes:
measure: heart rate
timeFrame: immediate
Secondary outcomes:
measure: oxygen saturation
timeFrame: immediate
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: University of Chieti-Pescara
city: Milan
country: Italy
facility: Buzzi hospital
Study officials:
References:
citation: Manzotti A, Cerritelli F, Lombardi E, La Rocca S, Chiera M, Galli M, Lista G. Effects of osteopathic treatment versus static touch on heart rate and oxygen saturation in premature babies: A randomized controlled trial. Complement Ther Clin Pract. 2020 May;39:101116. doi: 10.1016/j.ctcp.2020.101116. Epub 2020 Feb 8.
Clinical trial NCT00461435: Slowing the Degenerative Process, Long Lasting Effect of Hyperbaric Oxygen Therapy in Retinitis Pigmentosa
Official title: Slowing the Degenerative Process, Long Lasting Effect of Hyperbaric Oxygen Therapy in Retinitis Pigmentosa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinitis Pigmentosa
Lead sponsor: Azienda Policlinico Umberto I
Sponsor class: OTHER
First posted: 2007-04-18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Our aim was to assess the role and usefulness of Hyperbaric oxygen therapy in a long lasting period, assessing its efficacy on rescuing retinal photoreceptors and preserving visual function in retinitis pigmentosa.


Eligibility criteria: Inclusion Criteria:

* Patients with clearly hereditary RP (we performed to all of them genetic analysis for rhodopsin, and peripherin genes, only 4 patient with ADRP showed point mutation 3 on codon 135 and 1 on codon 347); best corrected visual acuity (BCVA) ≥ 0.50 logMAR; visual field ≥ 3 degree diameter circle; recordable ERG.

Exclusion Criteria:

* Exclusion criteria were: patients with sporadic RP; BCVA ≤ 0.50 logMAR; visual field ≤ 3 degree diameter circle; not recordable ERG.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Azienda Policlinico Umberto I
Study officials:
affiliation: Policlinico Umberto I, Dipartimento di Oftalmologia
name: Enzo Maria Vingolo, PH.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02796235: Prospective and Monocentric Study of the Incidence of Venous Thromboembolic Disease (VTE) in Spinal Cord Injury (SCI) Patient Between 3 and 12 Months After SCI
Official title: Prospective and Monocentric Study of the Incidence of Venous Thromboembolic Disease (VTE) in Spinal Cord Injury (SCI) Patient Between 3 and 12 Months After SCI
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Venous Thromboembolic Disease (VTE) in SCI patients is very common, its prevalence is 60 to 80% against 10-20% in the general population.

The risk of VTE is very important in the first weeks after spinal cord injury, and then declines with a prevalence of VTE slightly higher than the general population after 12 weeks. However there is no prospective study of incidence of VTE in SCI patients after 3 months. The investigators wish to conduct such a study during the year following spinal cord injury with performing venous Doppler ultrasound of the lower limbs 6, 9 and 12 months of the initial injuryassociated with a standardized clinical assessment, to know the incidence of VTE and determine prognostic factors for VTE.


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years.
* Patients having paraplegia or tetraplegia from C2 levels and above S1
* Paraplegia and tetraplegia of traumatic or non progressive SCI from traumatic or medical origin (ischemic, post-surgical, myelitis, benign tumor)
* Informed consent signed.
* stabilized respiratory situation with absence of chronic hypoxemia (hypoxemia being characterized by PaO2 steady state \<7.33 kPa)
* Patient not amputated.
* Absence of heart failure with ejection fraction below 30%
* Lack of solid neoplasia or progressive lymphoid haemopathy for 5 years, or myeloproliferative disorders (including polycythemia and thrombocythemia).
* No personal history of VTE and / or thrombophilia before the injury.

Exclusion Criteria:

* Unstabilized respiratory situation with presence of chronic hypoxemia (hypoxemia being characterized by PaO2 steady state \<7.33 kPa)
* Amputated Patient.
* Patients with heart failure with ejection fraction below 30%
* Solid neoplasia or progressive lymphoid haemopathy for 5 years, or myeloproliferative disorders (including polycythemia and thrombocythemia).
* Personal history of VTE and / or thrombophilia before the injury.
* Can not to follow during the study period
* Pregnant women
* Patient Refusal

Primary outcomes:
measure: Number of appearances of phlebitis in the lower limbs and / or pulmonary embolism in spinal cord injury (SCI) patient between 3 and 12 months after SCI
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: University Hospital
Study officials:
References:
Clinical trial NCT02681835: Endotracheal Intubation in Prehospital Scenario
Official title: Comparison of the C-MAC and Macintosh Laryngoscopes for Tracheal Intubation in Different Intubator Positions. A Randomized, Crossover, Manikin Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Intubation
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-02-12
Enrollment: 78
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: TREATMENT

Brief summary: We therefore designed this randomized crossover study to compare C-MAC with Macintosh laryngoscope in emergency intubation performed by paramedics according to three different intubator positions.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* maximum 1 year of work experience in medicine
* minimum 50 clinical intubations
* paramedics

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases

Primary outcomes:
measure: Time required for successful intubation
timeFrame: 1 day
Secondary outcomes:
measure: success rate of intubation attempt
timeFrame: 1 day
measure: cumulative success ratios related to time
timeFrame: 1 day
measure: Ease of intubation
timeFrame: 1 day
measure: Cormack&Lehane grade
timeFrame: 1 day
measure: Dental Compression
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw, Department of Emergency Medicine
state: Masovia
Study officials:
References:
Clinical trial NCT02026635: Cardiac Compass With Optivol® to Negate Future Inpatient Re-admissions Through Monitoring in HF Patients (CONFIRM-HF)
Official title: Cardiac Compass With Optivol® to Negate Future Inpatient Re-admissions Through Monitoring in Heart Failure Patients (CONFIRM-HF)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Failure
Keywords: heart failure
Optivol® cardiac device
Medtronic CareLink
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2014-01-03
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: hospital inpatients

Brief summary: A research study to determine if heart failure can be medically managed using data collected from cardiac monitoring devices


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Admission for worsening of HF
* Discharged to home
* Have appropriate cardiac device with OptiVol® implanted for at least 34 days prior to enrollment
* Enrolled in Carelink® system and able to transmit data
* Able to participate for at least 3 months

Exclusion Criteria:

* Post heart transplant or actively listed
* End-stage (Stage D) HF, including treatment with chronic ionotropic drugs or left ventricular assist device support
* Stage IV or V chronic renal dysfunction (GFR \<25 mol/min per 1.73 M2)
* Severe Chronic Obstructive Pulmonary Disease (COPD) requiring home oxygen
* Severe pulmonary hypertension not due to left-sided HF

Primary outcomes:
measure: Physician Use of Cardiac Compass Reports to Determine HF Treatment Decisions
timeFrame: 90 days from enrollment
Secondary outcomes:
measure: Heart Failure Clinical Events
timeFrame: 90 days from enrollment
measure: Assess Patient-Reported Quality of Life
timeFrame: 90 days from enrollment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: David J Whellan, MD MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01337635: Vitamin D Deficiency and Atopic Dermatitis
Official title: Treatment Of Vitamin D Deficiency And Effect On Atopic Dermatitis Severity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atopic Dermatitis
Vitamin D Deficiency
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Children's Hospital and Health System Foundation, Wisconsin
First posted: 2011-04-19
Enrollment: 7
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Atopic dermatitis is a chronic skin disease characterized by a defective skin barrier, inflammation, and increased propensity for skin infections. Vitamin D is a fat-soluble vitamin that is primarily acquired through local production in the skin after ultraviolet light exposure but can also be obtained through natural and supplemental dietary sources. This randomized controlled trial will examine the effects of vitamin D repletion on atopic dermatitis severity in patients with diagnosed deficiency. The investigators hypothesize that pediatric patients with moderate or severe atopic dermatitis and vitamin D deficiency will have improved cutaneous disease after treatment with high dose as compared to standard dose vitamin D.


Eligibility criteria: Inclusion Criteria:

* Serum 25-hydroxyvitamin D level \<20 ng/ml (\<50 nmol/L)
* Diagnosed with atopic dermatitis by a CHW pediatric dermatologist
* Age 1-18 years old
* Primary residence in Milwaukee County
* Moderate and severe atopic dermatitis (Severity Scoring of Atopic Dermatitis \[SCORAD\] score greater than 15)
* On clinic protocol treatment for their atopic dermatitis (desonide ointment twice daily for the face and groin, triamcinolone 0.1% ointment twice daily for other areas)

Primary outcomes:
measure: Atopic Dermatitis Severity at the Completion of Treatment
timeFrame: 6 weeks
Secondary outcomes:
measure: Time to Restart Topical Steroids
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Children's Hospital and Health System Foundation, Wisconsin
name: Yvonne Chiu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00765635: Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal
Official title: Randomized, Placebo-Controlled Evaluation of Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ear Infection
Hearing Loss
Vertigo
Keywords: complete occlusion of the ear canal due to cerumen
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2008-10-03
Enrollment: 90
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: Accumulation of cerumen in the external ear canal is a common problem. The presence of cerumen not only interferes with the clinician's view of the tympanic membrane, but may also result in hearing loss and vertigo, and may predispose to ear infections.

Removal of cerumen is facilitated by the use of a variety of ceruminolytics, or wax solvents. The current study was designed to evaluate the ceruminolytic effects of a single, brief application of the two most frequently used products in the investigators area, containing chlorobutanol or potassium carbonate with or without irrigation in the primary care setting in a randomized, single-blind trial. To our knowledge, this is the first randomized study comparing ceruminolytics with chlorobutanol versus potassium carbonate.

Detailed description: INTERVENTIONS: Subjects were randomly assigned to one of three different treatments: Otocerum®; Taponoto ®, and a control group with sterile saline solution (NaCl 0.9%, Braun Medical SA, Barcelona, Spain). The test medication was instilled into an occluded ear for 15 minutes. Following this treatment, the subject's ear was irrigated with 50 mL of water. The main outcome was the proportion of tympanic membranes that were completely visualized after cerumenolytic agents or saline, alone or with irrigation if needed.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ear cerumen

Exclusion Criteria:

* Infection

Primary outcomes:
measure: proportion of tympanic membranes that were completely visualized after cerumenolytic agents or saline, alone or with irrigation if needed
timeFrame: 2008
Secondary outcomes:
measure: adverse effects
timeFrame: 2008
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References:
citation: Roland PS, Eaton DA, Gross RD, Wall GM, Conroy PJ, Garadi R, Lafontaine L, Potts S, Hogg G. Randomized, placebo-controlled evaluation of Cerumenex and Murine earwax removal products. Arch Otolaryngol Head Neck Surg. 2004 Oct;130(10):1175-7. doi: 10.1001/archotol.130.10.1175.
Clinical trial NCT01996735: Ticagrelor and Adenosine
Official title: The Effect of Ticagrelor on the Adenosine System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Endothelial function
Adenosine receptor stimulation
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Preclinical studies have shown that the P2Y12 receptor antagonist ticagrelor can increase the extracellular concentration of the endogenous nucleoside adenosine by inhibiting the cellular uptake of adenosine via the equilibrative nucleoside transporter (ENT). This mechanism can contribute to the beneficial effects and to the side effects (dyspnea) of ticagrelor in patients with an acute myocardial infarction. In the current research proposal, we aim to investigate whether ticagrelor increases adenosine receptor stimulation in humans in vivo by ENT inhibition.


Eligibility criteria: Inclusion Criteria:

* Male sex
* Age 18-40 years
* Healthy
* Written informed consent

Exclusion Criteria:

* Smoking
* Hypertension (Blood pressure \>140 mmHg and/or \>90 mmHg - SBP/DBP-)
* Diabetes Mellitus (fasting glucose \> 7.0 mmol/L or random \> 11.0 mmol/L)
* History of any cardiovascular disease
* History of chronic obstructive pulmonary disease (COPD) or asthma
* Bleeding tendency
* Concomitant use of medication
* Renal dysfunction (MDRD \< 60 ml/min)
* Liver enzyme abnormalities (ALAT \> twice upper limit of normality)
* Thrombocytopenia (\<150\*109/ml)
* Second/third degree AV-block on electrocardiography

Primary outcomes:
measure: Forearm blood flow response
timeFrame: 2 hours after intake of ticagrelor/placebo
measure: Forearm blood flow response
timeFrame: Directly after 2 and 5 minutes of forearm ischemia
Secondary outcomes:
measure: Forearm blood flow respons
timeFrame: Directly after administration of dipyridamole
measure: ex-vivo adenosine uptake in isolated erythrocytes
timeFrame: 2 hours after intake of studymedication
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: N. Riksen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: G. Rongen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept Cardiology, Canisius Wilhelmina Hospital Nijmegen
name: M. Gomes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: S. El Messaoudi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van den Berg TN, El Messaoudi S, Rongen GA, van den Broek PH, Bilos A, Donders AR, Gomes ME, Riksen NP. Ticagrelor Does Not Inhibit Adenosine Transport at Relevant Concentrations: A Randomized Cross-Over Study in Healthy Subjects In Vivo. PLoS One. 2015 Oct 28;10(10):e0137560. doi: 10.1371/journal.pone.0137560. eCollection 2015.
Clinical trial NCT00314535: Optimization of Spectroscopic Imaging Parameters and Procedures for Prostate at 3 Tesla Using an External Probe
Official title: Optimization of Spectroscopic Imaging Parameters and Procedures for Prostate at 3 Tesla Using an External Probe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2006-04-14
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Local Healthy Volunteers

Brief summary: Magnetic resonance (MR) spectroscopic techniques are to be developed to obtain the best data possible at 3 Tesla (3T) for the prostate.


Eligibility criteria: Inclusion Criteria:

* Subject 18 years of age and over

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Gino Fallone, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04427735: Effect of Covid-19 Epidemic on Primary PCI in Patients With STEMI
Official title: Effect of Covid-19 Epidemic on Primary PCI and Prognosis in Patients With Acute STEMI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: STEMI
Keywords: covid-19
STEMI
primary PCI
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with definite diagnosis of acute ST segment elevation myocardial infarction and emergency PCI intervention

Brief summary: The epidemic of covid-19 has spread all over the world and has a great impact on people's health and life. It is necessary to study the treatment of STEMI patients in the real world under the influence of the epidemic,which provide effective suggestions and strategies for emergency and severe treatment.

Detailed description: The epidemic of covid-19 has spread all over the world and has a great impact on people's health and life. The patients' prognosis is poor because the epidemic situation runs on medical resources, delays the diagnosis and treatment of other diseases such as cardiovascular diseases, and the patients' willingness to see a doctor is reduced. In particular, the delay in the treatment of STEMI, which needs PCI treatment, will cause more damage to the patients. It is necessary to study the treatment of STEMI patients in the real world under the influence of the epidemic. In this study, STEMI patients who experienced emergency PCI treatment after the covid-19 outbreak in 2020 were included, and compared with the data of the same period in 2019,we will analyze the pre hospital treatment time, vascular opening time,and the major cardiovascular adverse events, which provide effective suggestions and strategies for emergency and severe treatment.

Eligibility criteria: Inclusion Criteria:

* Continuous inclusion of patients with definite diagnosis of acute ST segment elevation myocardial infarction and emergency PCI intervention.

Exclusion Criteria:

* Febrile patients, patients with severe infection,
* ST segment elevation myocardial infarction during hospitalization,
* Patients who could not cooperate with each other.

Primary outcomes:
measure: MACE (major adverse cardiovascular events)
timeFrame: 1 year
measure: all-cause death
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
Study officials:
affiliation: Beijing Friendship Hospital
name: Hongwei Li
role: STUDY_CHAIR
References:
citation: Gong X, Zhou L, Dong T, Ding X, Zhao H, Chen H, Li H. Impact of COVID-19 pandemic on STEMI undergoing primary PCI treatment in Beijing, China. Am J Emerg Med. 2022 Mar;53:68-72. doi: 10.1016/j.ajem.2021.11.034. Epub 2021 Nov 24.