louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04758286: Anesthetic & Surgical Protocol for Emergency Surgeries During the Era of COVID-19
Official title: Protocol for Anesthesia for Emergency Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
Anesthesia
Surgery
Outcomes
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2021-02-17
Enrollment: 209
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All patients presenting with surgical emergency
Primary purpose: TREATMENT

Brief summary: A protocol applied during anesthesia and surgical interventions for patients with emergency surgical conditions during the era of COVID-19 disease

Detailed description: All COVID-19 patients who were admitted to emergency departments presenting with emergency surgical conditions were evaluated for assurance of having COVID-19 disease. Then, the appropriate anesthetic procedure was applied and the appropriate surgical intervention was performed.

Eligibility criteria: Inclusion Criteria:

* Assured diagnosis of COVID-19 by RT-PCR

Exclusion Criteria:

* No

Primary outcomes:
measure: Questionnaire
timeFrame: Up to two days
Secondary outcomes:
measure: Physiologic assessment
timeFrame: Up to one day
measure: Surgical follow-up
timeFrame: Up to 10 days
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Faculty of Medicine
state: Qalubia
Study officials:
affiliation: Faculty of medicine, Banha University, Egypt
name: Adel Alkholy, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01531686: Observational Study of CT Dye Administration Through the Intraosseous Vascular Access Route
Official title: An Observational Study to Determine the Safety and Effectiveness of Intraosseous Vascular Access for the Delivery of CT Contrast Dye
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Intraosseous Vascular Access Patients Requiring CT Exam
Keywords: intraosseous vascular access
CT examination
Lead sponsor: Vidacare Corporation
Sponsor class: INDUSTRY
First posted: 2012-02-13
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients that have received intraosseous vascular access as standard of care and require CT examination

Brief summary: Intraosseous vascular access can be used to effectively and safely deliver contrast dye for CT examination.

Detailed description: intraosseous vascular access in the proximal humerus can be used to delivery contrast dye for CT examination.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Has received intraosseous vascular access at the proximal humerus insertion site via EZ-IO as standard of care
* Requires CT examination with contrast media delivery via proximal humerus intraosseous catheter, as standard of care
* Cognitively and physically able to give written consent to participate in the study

Exclusion Criteria:

* Fracture in target bone, or significant trauma to the site
* Excessive tissue and/or absence of adequate anatomical landmarks in target bone
* Infection in target area
* IO insertion in past 24 hours, prosthetic limb or joint or other significant orthopedic procedure in target bone
* Allergy to contrast media
* Imprisoned
* Pregnant
* Requires English language translation other than Spanish
* Has received IO access with an IO catheter other than the EZ-IO system

Primary outcomes:
measure: Adequate CT image
timeFrame: at time of CT examination average time is within 24 hours
measure: number of participants with adverse events within 24 hours of CT exam
timeFrame: within 24 hours of CT exam
measure: number of participants with adverse events within 30 days of CT exam
timeFrame: within 30 days of CT exam
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa Medical Center
state: Arizona
city: Sylmar
country: United States
facility: Olive View UCLA Medical Center
state: California
city: Gainesville
country: United States
facility: Shands Critical Care Center and Cancer Hospital
state: Florida
city: Myrtle Beach
country: United States
facility: Grand Strand Regional Medical
state: South Carolina
Study officials:
affiliation: Sponsor Company- Vidacare Corporation
name: Thomas Philbeck, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04432363: Effects of tDCS in M1 and DLPFC on Pain Processing in Healthy Volunteers
Official title: Effects of Transcranial Direct Current Stimulation on Primary Cortex and Prefrontal Dorsolateral Cortex in Pain Processing on Healthy Volunteers: A Triple Blind Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Processing in Healthy Volunteers
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Three groups cross over study with two intervention groups and one sham group.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of a direct current applied transcranial over two cortical areas on healthy volunteers' pain processing.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 40 years
* Comprehension of the study tasks

Exclusion Criteria:

* Presence of pain in the previous 6 months
* Altered sensitivity in the tested regions
* Intolerance to electrotherapy
* Presence of pacemakers or any other implanted device
* Ulcers or scars in the skin at the location of the electrodes
* Treatment with direct current stimulation within one week
* Pregnancy
* Frequent headaches
* Epilepsy
* History of neuromuscular disease
* Previous clinical history of cervical surgery
* Injuries or surgery affecting the upper limb
* diabetes mellitus
* Cardiovascular diseases
* Oncological diseases
* Consumption of analgesic drugs 7 days before the study

Primary outcomes:
measure: Conditioned Pain Modulation
timeFrame: Pre-intervention and immediately after treatment
measure: Pain pressure algometer temporal summation
timeFrame: Pre-intervention and immediately after treatment
Secondary outcomes:
measure: Pain pressure threshold
timeFrame: Pre-intervention and immediately after treatment
measure: Pain pressure tolerance
timeFrame: Pre-intervention and immediately after treatment
measure: Neural mechanosensitivity
timeFrame: Pre-intervention and immediately after treatment
measure: Cold hyperalgesia with a cold pack
timeFrame: Pre-intervention and immediately after treatment
measure: Isometric grip strength
timeFrame: Pre-intervention and immediately after treatment
Other outcomes:
Locations:
city: Alcorcon
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Josue Fernandez Carnero, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04132063: Generic Substitution of Original Levetiracetam in Thai Epilepsy Patients
Official title: Efficacy and Safety of Generic Substitution of Original Levetiracetam in Patients With Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Epilepsy
Generic
Levetiracetam
Therapeutic equivalency
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any epileptic patients who received generic substitution to original levetiracetam from February 2016 to May 2018

Brief summary: The retrospective pre-post observational study was conducted to evaluate the real-world evidence of efficacy and tolerability of generic levetiracetam (oral tablet) which was switched from original levetiracetam (oral tablet) in patients with epilepsy at the national hospital for neurology and neurosurgery in Thailand. Epilepsy patients who received generic substitution to original levetiracetam at the same dose and had stable conditions of seizure were only included. In the period of 6 months, the investigators assessed the change of seizure frequency, the incidence of hospitalization due to breakthrough seizure, the incidence of adverse events and the incidence of composite outcomes related to dosage adjustment of antiepileptic drugs.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of epilepsy for at least 6 months prior to generic levetiracetam substitution;
* Same dosage form and strength of generic substitution to original levetiracetam;
* Stable dose of original levetiracetam and stable seizure frequency prior to generic levetiracetam substitution;
* Stable dose of generic levetiracetam after generic levetiracetam substitution

Exclusion Criteria:

* Absence seizure with levetiracetam monotherapy;
* Original levetiracetam in dosage form of oral solution or intravenous solution prior to generic levetiracetam substitution;
* Poor compliance;
* Death or loss of follow up;
* Unavailable data for evaluation of outcomes

Primary outcomes:
measure: Change from baseline seizure frequency
timeFrame: At baseline, 3 and 6 months after generic levetiracetam substitution
Secondary outcomes:
measure: Hospitalization
timeFrame: During 6 months of generic levetiracetam substitution
measure: Adverse events
timeFrame: During 6 months of generic levetiracetam substitution
measure: Composite outcomes
timeFrame: During 6 months of generic levetiracetam substitution
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Prasat Neurological Institute
Study officials:
affiliation: Mahidol University
name: Jannapas Tharavichitkun
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03926663: Intranasal Injection of Dexmedetomidine and Bupivacaine in Septoplasty Surgeries
Official title: Effects of Intranasal Injection of Dexmedetomidine Plus Bupivacaine on Anesthesia & Analgesia in Septoplasty Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Intranasal Dexmedetomidine
Intranasal Bupivacaine
Septoplasty Surgeries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pain is particularly common after nasal surgery, especially when bone manipulation and periosteal irritation are involved. Appropriate pain control is an important consideration in the post-surgical management of patients.

Detailed description: Multiple researches and clinical observations suggest that pain reduction can be achieved in nasal surgery by using local anesthesia.The combination of local anesthetic infiltration, directly in the surgical field, with general anesthesia provides beneficial analgesic effects by blocking nociceptive pathways, and there by it reduces the need for systemic analgesics.

The use of α-2 Adrenergic receptor (adrenoceptor) agonists in anesthesia were the focus of interest for their sedative, analgesic, and perioperative sympatholytic and cardiovascular stabilizing effects with reduced anesthetic requirements. α-2 agonists, inhibit substance P release in the nociceptive pathway at the level of the dorsal root neuron; in addition, α-2 adrenergic receptors located at nerve endings may have a role in the analgesic effect of the drug by preventing norepinephrine release.

In this study, the combined effects of dexmedetomidine with bupivacaine as local anesthetics vs bupivacaine, will be investigated in septoplasty to determine the need for rescue drugs as propanlol and nitroglycerine, as hypotensive agents,for bloodless surgical field and optimal procedure for pain control

Eligibility criteria: Inclusion Criteria:

* Patients aged from 18- 60 years
* ASA physical status I
* Undergoing septoplasty

Exclusion Criteria:

* Patients with cardiovascular disease (congestive heart failure, coronary artery disease, hypertension.
* History of renal or hepatic insufficiency
* Endocrinal Diseases

Primary outcomes:
measure: The precentage of patients that will take rescue drugs as nitroglycerin, propranolol.
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Faculty of medicine,Beni-Suef University
Study officials:
References:
Clinical trial NCT04007263: A Multiple Ascending Dose Study of Safety and Pharmacokinetics of NP10679 in Normal Healthy Volunteers
Official title: A Phase 1, Randomized, Double Blind, Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of NP10679 in Healthy Adults"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke, Ischemic
Pain, Postoperative
Substance Abuse
Subarachnoid Hemorrhage
Keywords: NMDA
GluN2B
Lead sponsor: Neurop Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Pharmaron
First posted: 2019-07-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This multiple ascending dose study assesses the safety, tolerability and pharmacokinetics of NP10679 when delivered intravenously in escalating dose levels in comparison to placebo.

Detailed description: NP10679 is a pH dependent inhibitor of the GluN2B subtype of the NMDA receptor. Compounds of this drug class are hypothesized to be beneficial in a number of central nervous system disorders, including brain ischemia associated with stroke, subarachnoid hemorrhage, severe pain, major depression and substance abuse disorders. This study uses a double blind, adaptive design approach to evaluate the safety, tolerability and pharmacokinetics of 5 once daily doses of NP10679 when delivered intravenously in three escalating dose levels in comparison to placebo

Eligibility criteria: Inclusion Criteria:

* Male and female subjects aged 18 to 55 years
* Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
* If of child bearing potential (both men and women) must agree to use 2 forms of contraceptive methods for the duration of study.

Exclusion Criteria:

* Clinical laboratory values greater than or equal to 2 times the upper limit of normal.
* Recent history (within 2 yrs) or current tobacco use.

Primary outcomes:
measure: Incidence of adverse events as a measure of safety and tolerability
timeFrame: 10 days
measure: Plasma concentration of parent drug
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Pharmaron CPC
state: Maryland
Study officials:
References:
Clinical trial NCT00800163: Improving Door-to-Balloon Time in STEMI
Official title: Emergency Department Physician Activation of the Catheterization Laboratory and Immediate Transfer to an Immediately Available Catheterization Lab Reduce Door-to-Balloon Time in ST-Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Lead sponsor: St. Francis Hospitals & Health Centers
Sponsor class: OTHER
First posted: 2008-12-01
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The investigators prospectively determined the impact on median door-to-balloon time of a protocol mandating (1) emergency department physician activation of the catheterization lab and (2) immediate transfer of the patient to an immediately available catheterization lab by an in-house transfer team consisting of an emergency department nurse, a critical care unit nurse, and a chest pain unit nurse.

Detailed description: Please see Circulation. 2007;116:67-76

Eligibility criteria: Primary Study Inclusion Criteria:

* ST-elevation myocardial infarction patients who undergo percutaneous intervention within 24 hours of ED arrival

Exclusion Criteria:

* Patients who are inpatients

A registry of all patients who undergo emergency cardiac catheterization irrespective of etiology is maintained.

Primary outcomes:
measure: Door-to-Balloon Time
timeFrame: 24 hours
Secondary outcomes:
measure: Infarct Size
timeFrame: 48 hours
measure: In-Hospital Mortality
timeFrame: ~ 7 days (during index hospitalization)
measure: Hospital Length of Stay
timeFrame: ~2-7 days (during index hospitalization)
measure: Hospital Costs
timeFrame: ~2-7 days (during Index Hospitalization) and One Year Followup
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: St. Francis Heart Center
state: Indiana
Study officials:
affiliation: Indiana Heart Physicians/St. Francis Heart Center
name: Umesh N Khot, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khot UN, Johnson ML, Ramsey C, Khot MB, Todd R, Shaikh SR, Berg WJ. Emergency department physician activation of the catheterization laboratory and immediate transfer to an immediately available catheterization laboratory reduce door-to-balloon time in ST-elevation myocardial infarction. Circulation. 2007 Jul 3;116(1):67-76. doi: 10.1161/CIRCULATIONAHA.106.677401. Epub 2007 Jun 11.
citation: Khot UN, Johnson-Wood ML, Geddes JB, Ramsey C, Khot MB, Taillon H, Todd R, Shaikh SR, Berg WJ. Financial impact of reducing door-to-balloon time in ST-elevation myocardial infarction: a single hospital experience. BMC Cardiovasc Disord. 2009 Jul 26;9:32. doi: 10.1186/1471-2261-9-32.
Clinical trial NCT03371563: Erythema Migrans in Elderly
Official title: Clinical Course, Serologic Response and Long-term Outcome in Elderly Patients With Early Lyme Borreliosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lyme Disease
Erythema Migrans
Elderly Infection
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2017-12-13
Enrollment: 1220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: young (18-44 years), middle-aged (45-64 years) and elderly 65 or more years) patients with erythema migrans

Brief summary: The investigators will focus on elderly patients with early Lyme borreliosis with the aim of assessing clinical course, serological response and treatment outcome of the disease as compared to younger adults. Furthermore, the investigators will compare the prevalence of nonspecific symptoms among patients and among age-matched controls without a history of Lyme borreliosis.


Eligibility criteria: Inclusion Criteria:

* erythema migrans

Exclusion Criteria:

* pregnancy or lactation
* immunocompromised
* taking antibiotic with antiborrelial activity within 10 days
* received \<10 days of antibiotic therapy for erythema migrans
* had an intercurrent episode of Lyme borreliosis during follow-up

Primary outcomes:
measure: Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 14 days postenrollment in patients treated for erythema migrans
timeFrame: Study point: at 14 days post-enrollment.
measure: Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 2 months postenrollment in patients treated for erythema migrans with doxycycline for 7 or 14 days
timeFrame: Study point: at 2 months post-enrollment.
measure: Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 6 months postenrollment in patients treated for erythema migrans
timeFrame: Study point: at 6 months post-enrollment.
measure: Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 12 months postenrollment in patients treated for erythema migrans
timeFrame: Study point: at 12 months post-enrollment.
Secondary outcomes:
measure: Change in occurrence of nonspecific symptoms from baseline to 6 months and to 12 months post-enrollment in patients with erythema migrans and control subjects
timeFrame: Study points will be: at enrollment, at 6, and at 12 months post-enrollment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00042263: Healthy Environments Partnership
Official title: Social and Physical Environments and Health Disparities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Health
Keywords: health disparities
social environment
physical environment
racial health disparities
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2002-07-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 25
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: The Healthy Environments Partnership was established in October 2000, as a part of the National Institute of Environmental Health Sciences "Health Disparities Initiative." The Healthy Environments Partnership seeks to expand the knowledge base of how social and economic inequalities are linked to disparities in cardiovascular health among residents of Detroit. The Healthy Environments Partnership is a project of the Detroit Community-Academic Urban Research Center. The partners are: Brightmoor Community Center, Butzel Family Center, the Detroit Health Department, Friends of Parkside, Henry Ford Health System, Southwest Counseling and Development Services, Southwest Detroit Environmental Vision and University of Detroit Mercy and the University of Michigan School of Public Health, School of Nursing, and the Institute for Social Research.


Eligibility criteria: * Age 25 and older
* Resident of three designated areas of Detroit, MI

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Public Health
state: Michigan
Study officials:
References:
Clinical trial NCT01478763: Vitrous Analysis in Proliferative Diabetic Retinopathy
Official title: Analysis of Vitreous Proteins in Patients Undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proliferative Diabetic Retinopathy
Keywords: PDRP
vitreous
protein
vitrectomy
Lead sponsor: St. Erik Eye Hospital
Sponsor class: OTHER
First posted: 2011-11-23
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing pars plana vitrectomy for proliferative diabetic retinopathy

Brief summary: Analysis of vitreous proteins in patients undergoing pars plana vitrectomy for proliferative diabetic retinopathy

Detailed description: To analyse and compare vitreous proteins in patients undergoing pars plana vitrectomy for proliferative diabetic retinopathy.

Eligibility criteria: Inclusion Criteria:

* proliferative diabetic retinopathy with vitreous hemorrhage

Exclusion Criteria:

* vitreous hemorrhage of other cause than proliferative diabetic retinopathy
* previous vitrectomy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: St. Erik Eye Hospital
state: NonUS
Study officials:
affiliation: St. Erik Eye Hospital
name: Anders Kvanta, PhD
role: PRINCIPAL_INVESTIGATOR
References: