louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04470791: Cryotherapy as a Coadjuvant in Crotaline Snakebite Management With Antivenom.
Official title: Cryotherapy as a Coadjuvant in the Management of Crotaline Snakebite With F(ab')2 Antivenom: A Randomized Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Snake Bites
Lead sponsor: Hospital Juarez de Mexico
Sponsor class: OTHER_GOV
First posted: 2020-07-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized pilot study was performed that included patients of both genders and over 18 years old with a snakebite of envenomation grade II who were admitted to the Clinical Toxicology Service of the Hospital Juárez de México.
Primary purpose: TREATMENT

Brief summary: The study aimed to determine the effect of local cryotherapy as a coadjuvant in patients with snakebite treated with F(ab')2 therapy venom at the Hospital Juárez de Mexico.

Detailed description: Introduction: Local cryotherapy induces vasoconstriction, which leads to a reduction in the inflammatory process. However, the efficacy of local cryotherapy as a coadjuvant in snakebite treatment with F(ab')2 antivenom is unknown.

Objective: Determine the effect of local cryotherapy as a coadjuvant in patients with snakebite treated with F(ab')2 therapy venom.

Material and methods: Subjects with snakebite envenomation accident grade II, according to the Christopher-Rodning classification, were enrolled from the Clinical Toxicology Service of the Hospital Juárez de México. One group of patients received F(ab')2 antivenom therapy (antivipmyn®) plus local cryotherapy, and another group received only F(ab')2 antivenom therapy.

Eligibility criteria: Inclusion Criteria:

* Patients of both genders and any age with a snake bite of poison grade II who were admitted to the Clinical Toxicology Service of the Hospital Juárez de México.

Exclusion Criteria:

* Patients of both genders and any age with a snake bite of poison grade I, III or IV who were admitted to the Clinical Toxicology Service of the Hospital Juárez de México.

Primary outcomes:
measure: Distal circumference of the affected limb on hospital admission.
timeFrame: Baseline.
measure: Proximal circumference of the affected limb on hospital admission.
timeFrame: Baseline.
measure: Middle circumference of the affected limb on hospital admission.
timeFrame: Baseline.
measure: Distal circumference of the affected limb on hospital admission.
timeFrame: up to 24 weeks
measure: Proximal circumference of the affected limb on hospital admission.
timeFrame: up to 24 weeks.
measure: Middle circumference of the affected limb on hospital admission.
timeFrame: up to 24 weeks.
Secondary outcomes:
measure: Hospital stay.
timeFrame: up to 24 weeks.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04712591: The EBC Recovery Study
Official title: Electrophysiologic Biomarkers of Consciousness (EBC) Recovery After Brain Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Intracerebral Haemorrhage
Subarachnoid Haemorrhagic Stroke
Keywords: Consciousness
Coma
Recovery
Electroencephalogram
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2021-01-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who present to the intensive care unit after ABI and are unconscious. Additionally, healthy volunteers will be recruited.

Brief summary: The purpose of this research study to find out if clinically unconscious acute brain injury patients that show brain activation to music and language on electroencephalogram (EEG) (bedside test) have better outcomes and wake up in the future.


Eligibility criteria: Inclusion Criteria:

For ABI Participants

* ABI adult (18 years and older) patients who are admitted to the intensive care unit
* Unconscious with Glasgow Coma Scale (GCS) \&lt;8 on presentation and unable to follow bedside commands.
* A negative COVID-19 test on arrival

For Healthy Volunteers:

* 18 years and older

Exclusion Criteria:

For All Participants:

* \&lt;18 years of age
* Pregnant woman
* Patients with cardiac arrest on presentation

Primary outcomes:
measure: Glasgow Outcome Scale-Extended (GOSE) Scale
timeFrame: Up to 5 years
Secondary outcomes:
measure: Coma Recovery Scale - Revised (CRS-R)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: University of Miami
name: Ayham Alkhachroum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05073991: Incidence of Mortality and Complications After Lung Surgery, Open Thoracic Aortic Repair, TEVAR, EVAR.
Official title: Incidence of Perioperative Mortality and Major Complications in Patients Who Underwent Lung Surgery, Open Thoracic Aortic Repair, Thoracic Endovascular Aortic Repair (TEVAR), and Endovascular Aortic Repair (EVAR). A Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Morality
Lung Cancer
Aortic Aneurysm
Aortic Dissection
Keywords: Mortality
Major complications
Lung surgery
Open aortic surgery
Thoracic endovascular aortic repair
Endovascular aneurysm repair
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 2224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent one of these types of surgery 1) thoracic surgery, 2) open thoracic aortic surgery, 3) TEVAR and 4) EVAR

Brief summary: Lung surgery, open aortic surgery, TEVAR, and EVAR are major operations that carry a higher incidence of perioperative mortality and complications compare to other surgery. The study of the incidence of mortality and complications will help the hospital to benchmark with the others. Also the study of the risk factors of mortality and major complications will help to improve the patients' outcomes.


Eligibility criteria: Inclusion Criteria:

Patients underwent

* thoracic surgery
* open thoracic aortic surgery
* TEVAR
* EVAR

Exclusion Criteria:

* Emergency lung surgery
* Conversion from TEVAR to open thoracic surgery
* Conversion from EVAR to open aortic surgery

Primary outcomes:
measure: Incidence of mortality and major complications after lung surgery
timeFrame: 30 days
measure: Incidence of mortality and major complications after open aortic surgery
timeFrame: 30 days
measure: Incidence of mortality and major complications after TEVAR
timeFrame: 30 days
measure: Incidence of mortality and major complications after EVAR
timeFrame: 30 days
Secondary outcomes:
measure: Risk factors of mortality and major complications after lung surgery
timeFrame: 30 days
measure: Risk factors of mortality and major complications after open aortic surgery
timeFrame: 30 days
measure: Risk factors of mortality and major complications after TEVAR
timeFrame: 30 days
measure: Risk factors of mortality and major complications after EVAR
timeFrame: 30 days
Other outcomes:
measure: Incidence of postoperative delirium
timeFrame: 30 days
measure: Incidence of low muscle mass
timeFrame: 7 days
measure: Risk factors of postoperative stroke.
timeFrame: 30 days
Locations:
city: Bangkoknoi
country: Thailand
facility: Anesthesiology Department Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Sirilak Suksompong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05775991: COACH-Cog Intervention Adaptation Focus Groups
Official title: Enhancing Triadic Communication About Cognition for Older Adults With Alzheimer's Disease or Related Dementias Facing a Cancer Management Decision - Focus Groups
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focus Groups
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-03-20
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Focus groups will be conducted with the following stakeholders:

1. Medical oncologists
2. Clinicians with expertise in cognitive impairment and dementia
3. Older patients with cancer
4. Caregivers of patients with dementia

Brief summary: To gather key stakeholder input for feedback on the adaption of the COACH GA intervention (i.e., develop COACH-Cog) to enhance triadic communication among oncologists, care partners and patients with ADRD.


Eligibility criteria: Inclusion/Exclusion Criteria:

The inclusion and exclusion criteria for participants are that they must be able to consent for themselves and must speak English.

For the medical oncologist focus group, participants must be a medical oncologist.

For the clinicians with expertise in cognitive impairment and dementia focus group, participants must be a clinician that treats patients with cognitive impairment and dementia.

For the older patients with cancer focus group, participants must be older than 65 years of age and have or had cancer.

For the caregivers of patients with dementia focus group, participants must be caregivers of patients with dementia or cognitive impairment.

Primary outcomes:
measure: Qualitative Analysis of Focus Group Audio-recording Transcripts. Open Coding Using Content Analysis Framework Will be Utilized to Assess Positive Regard for the Intervention and Potential Intervention Adaptations.
timeFrame: Through study completion approximately 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Wilmot Cancer Institute
state: New York
Study officials:
References:
Clinical trial NCT03942991: Anesthetic Efficacy Of 4% ArtpharmaDent Versus 2% Mepecaine-L in Extraction of Lower First Primary Molars
Official title: Anesthetic Efficacy Of 4% ArtpharmaDent Versus 2% Mepecaine-L for Infilteration Anesthesia in Extraction of Badly Decayed Lower First Primary Molars: Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Badly Decayed Lower First Primary Molars in Children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-05-08
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: parallel technique will be done where the investigator (will be blinded) will give one type on anesthesia then performing the extraction and evaluating the intraoperative pain ,the same procedure will be done for the other type of anesthesia.


Eligibility criteria: Inclusion Criteria:

* Children aged 6-8 years.
* Medically fit (ASA I, II).
* Mentally capable of communication.
* Having a mandibular first primary molar tooth that require Extraction.
* Child must give assent prior to participation, as well as parental informed written consent.
* Body weight \>20 kg.
* it should be the first dental treatment to the child

Exclusion Criteria:

* Medically and mentally compromised children.
* Children without a history of prolonged bleeding, platelet disorders, hypersensitivity,
* History of significant behavior management problems.
* Patients having active sites of pathosis in the area of injection.
* Patients who had taken analgesics or antibiotics in the 12-hrs preceding the injection.
* Patients allergic to Articaine and/or Mepivacaine and/or sulfur

Primary outcomes:
measure: Intra-Operative Pain during Extraction
timeFrame: Immediatly after etxraction
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02762591: Expanded Access of Pimavanserin for Patients With PD Psychosis
Official title: Expanded Access Program of Pimavanserin in Patients With Parkinson's Disease Psychosis
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Parkinson's Disease Psychosis
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2016-05-05
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this program is to provide patients with PDP access to pimavanserin until the product receives marketing approval from the FDA and is commercially available.


Eligibility criteria: Inclusion Criteria:

1. Patient meets one of the following criteria:

   1. Patient has participated in a previous study of pimavanserin for Parkinson's disease psychosis (PDP)
   2. New ("De novo") patients
2. A clinical diagnosis of Parkinson's disease with a minimum duration of 1 year
3. Female patients must be of non-childbearing potential
4. Psychotic symptoms must have developed after Parkinson's disease diagnosis was established
5. Patient that has received stereotaxic surgery for subthalamic nucleus deep brain stimulation must be at least 6 months post-surgery and the stimulator settings must have been stable for at least 1 month prior to Study Day 1 (Baseline) and must remain stable during the trial
6. The patient or Legally Authorized Representative (LAR) is willing and able to provide consent
7. The patient or LAR is willing and able to adequately communicate in English.

Exclusion Criteria:

1. Patient has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Parkinson's disease including, but not limited to, schizophrenia or bipolar disorder
2. Patient has had dementia prior to or concurrently with their diagnosis of Parkinson's disease that may be inconsistent with a Parkinson's diagnosis
3. Patient has current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic, or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the program
4. Patient has had a myocardial infarction in last six months
5. Patient has any surgery planned during the screening, treatment, or follow-up periods

Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all pre-specified entry criteria).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01795391: Comparison of Two New Generations Dressings in Intensive Care Unit
Official title: Comparison Between Two New Generation Dressings in the Prevention of Intravascular Catheter Related Complications in Intensive Care Units
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Catheter Related Complications
Keywords: Prevention
Dressings
Catheters
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 685
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalised in the Medical ICU and requiring an intravascular device during hospitalisation (peripheral or central)

Brief summary: Intravascular devices in intensive care units are often associated to complications. The investigators estimate that 23.5% of catheters placed and used in intensive care are subject to at least one complication; the goal is to demonstrate the effectiveness of the new Tegaderm ™ IV Advanced dressings to achieve a decrease of 35% in the number of complications associated with intravascular catheters in intensive care.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years with a central venous catheter, an arterial catheter, a hemodialysis catheter, a Swan Ganz catheter or a peripheral catheter inserted in the ICU or within the 24 before their arrival at the ICU in another ICU setting.
* Patients benefiting from the social security protection.

Exclusion Criteria:

* Patients under 18 years of age,
* Patients having known allergy or sensitivity to adhesive dressing materials

Primary outcomes:
measure: Number of catheters presenting any kind of complications.
timeFrame: From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.
Secondary outcomes:
measure: Number of infections related to poor adherent dressings.
timeFrame: From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.
Other outcomes:
measure: Number of participants presenting allergic adverse events.
timeFrame: From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.
measure: Cost of each dressing type strategy.
timeFrame: From the insertion of the catheter to its removal, an average time frame thant can go up to 4 weeks.
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble, Medical Intensive Care Unit
state: Isère
Study officials:
References:
Clinical trial NCT03460691: The Effect of Bariatric Surgery to Central Sensitization
Official title: Investigation of the Effect of Bariatric Surgery on Knee Pain, Disability, Quality of Life and Central Sensitization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bariatric Surgery
Central Sensitization
Keywords: bariatric surgery
central sensitization
knee pain
function
quality of life
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2018-03-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are morbid obesity and had decided to undergo bariatric surgery

Brief summary: Nowadays obesity is emerging as a very common health problem. It has been shown in various studies that obesity may be an important risk factor for the onset and progression of knee osteoarthritis (OA). The aim of this study is to determine the effects of bariatric surgery on knee pain, loss of function, quality of life and central sensitization.

Detailed description: Weight loss in patients with knee OA reduces pain and provides functional improvement. It has been shown that bariatric surgery combined with diet and exercise changes have positive effects on weight loss, knee pain and function.

Neuropathic pain is a disease that affects the somatosensory system or pain that results in a lesion. It has been reported that neuropathic pain is more frequently seen in patients with high body mass index.

The hyperreactivity of the central nervous system (CNS) plays an important role in the chronic pain of OA patients. It has been shown that CNS becomes hypersensitive in people with chronic OA pain and central sensitization phenomenon plays an important role in pain complaints reported by these patients.

The aim of this study is to determine the effects of bariatric surgery on knee pain, loss of function, quality of life and central sensitization.

Eligibility criteria: Inclusion Criteria:

* Patients decided to undergo bariatric surgery
* Patients with knee pain more than 3 months.

Exclusion Criteria:

* Patients with mental impairment,
* Patients with inflammatory rheumatic disease,
* Patients who had previously undergone knee surgery

Primary outcomes:
measure: numeric rating scale (NRS)
timeFrame: 6 months
measure: Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
timeFrame: 6 months
measure: Nottingham Health Profile
timeFrame: 6 months
measure: Central Sensitization Inventory (CSI)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
name: Burcu Metin Ökmen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01730391: Neisseria Meningitidis Burden of Disease Study
Official title: Neisseria Meningitidis Burden of Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Streptococcus Pneumoniae
Neisseria Meningitidis
Haemophilus Influenzae
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 521
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects visiting the hospital with suspected bacterial meningitis in The Philippines and Vietnam.

Brief summary: This study aims to provide an estimate of the proportion of suspected cases of bacterial meningitis that are due to N. meningitidis and the serogroup responsible in The Philippines and Vietnam.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes can and will comply with the requirements of the protocol or subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject/from the parent(s)/LAR of the subject.
* A male or female subject who visits the hospital with suspected bacterial meningitis.
* CSF sample taken as part of routine practice.

Exclusion Criteria:

* Child in care.

Primary outcomes:
measure: Prevalence of N. meningitis in CSF samples
timeFrame: At enrollment (Day 0)
measure: Serogroup of N. meningitis positive samples
timeFrame: At enrollment (Day 0)
Secondary outcomes:
measure: Further characterization of N. meningitidis using Multi Locus Sequence Typing
timeFrame: At enrollment (Day 0)
measure: Prevalence of Haemophilus influenzae and Streptococcus pneumoniae in CSF samples as causes of bacterial meningitis
timeFrame: At enrollment (Day 0)
measure: Serotype of Streptococcus pneumoniae positive samples
timeFrame: At enrollment (Day 0)
measure: Further classification of Haemophilus influenzae positive samples into Type B and non-B Types
timeFrame: At enrollment (Day 0)
measure: Total number of subjects with suspected bacterial meningitis (according to diagnostic criteria used by each participating hospital to identify this condition)
timeFrame: At enrollment (Day 0)
Other outcomes:
Locations:
city: Baguio City, Benguet
country: Philippines
facility: GSK Investigational Site
city: Quezon City
country: Philippines
facility: GSK Investigational Site
city: Hanoi
country: Vietnam
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: