louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01694992: Very Early Rehabilitation in Acute Ischemic Stroke
Official title: Randomized Clinical Trial of Very Early Rehabilitation Compared With Conventional Rehabilitation in Acute Ischemic Stroke in the Vascular Unit of the Hospital de Clínicas de Porto Alegre - HCPA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Stroke
Keywords: Stroke
Early Ambulation
Rehabilitation
Physical Therapy
Randomized controlled trial
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2012-09-27
Enrollment: 184
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: The purpose of this study is to evaluate the effectiveness of a rehabilitation (physiotherapy) program in patients with acute ischemic stroke in Acute Vascular Unit and in general ward of Hospital de Clínicas de Porto Alegre, and to verify the degree of disability at fourteenth and third month, functional improvement at third month, the frequency of deaths and incidence of complications due to immobility and quantify the time spent in hospital.


Eligibility criteria: Inclusion Criteria:

* Patients with clinical diagnosis of acute ischemic stroke (first or recurrent) confirmed by CCT or MRI admitted to the Acute Vascular Unit of HCPA between the first 48 hours of onset of symptoms.
* Patients older than 18 years.
* Patients clinically and hemodynamically stable (SBP 120-220 mmHg, SatO2 up to 92% with or without supplementation, HR between 60 and 100 bmp, body temperature below 38 and RR below 25 bpm).
* Patients are able to react to verbal commands even without being fully alert (Glasgow Scale above 8).
* Prior Rankin until 3
* Motor deficit and / or coordination measured by the NIHSS

Exclusion Criteria:

* Patients with clinical and / or hemodynamic instability
* Patients with hemorrhagic stroke or TIA (transient ischemic attack).
* Patients with progressive neurological disease and acute coronary disease and / or unstable.

Primary outcomes:
measure: Disability
timeFrame: three months
Secondary outcomes:
measure: Minimum or no Disability
timeFrame: three months
measure: Independence in activities of daily living
timeFrame: three months
measure: Long of stay at hospital
timeFrame: three month
measure: Death
timeFrame: three month
measure: Incidence of complications
timeFrame: three month
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre (Hospital)
state: Rio Grande do Sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre (Hospital)
name: Sheila CO Martins, Physician
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clark B, Whitall J, Kwakkel G, Mehrholz J, Ewings S, Burridge J. The effect of time spent in rehabilitation on activity limitation and impairment after stroke. Cochrane Database Syst Rev. 2021 Oct 25;10(10):CD012612. doi: 10.1002/14651858.CD012612.pub2.
Clinical trial NCT00496392: Comparison of Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq) in Cancer Breakthrough Pain (FT-019-IM)
Official title: An Open Label, Comparative, Randomised, Balanced Crossover Trial Comparing Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq®) in Breakthrough Pain in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: breakthrough pain in patients with cancer
Lead sponsor: Nycomed
Sponsor class: INDUSTRY
First posted: 2007-07-04
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Primary:

• To compare the efficacy of nasal fentanyl (NF) to oral transmucosal fentanyl (Actiq®) (hereafter Actiq) in the management of breakthrough pain in cancer patients.

Secondary:

* To compare patients' general impression and preference of NF and Actiq
* To explore the relationship between NF doses and dose of current opioid for breakthrough pain (BTP) and the relationship between dose of NF and of background opioid
* To assess safety and tolerability of NF


Eligibility criteria: Inclusion Criteria:

* Adult in- or out patient with cancer and breakthrough pain; using a stable, chronic opioid treatment for background pain.
* Minimum three BTP episodes per week and maximum four per day. Life expectancy of at least three months.
* Chemotherapy and palliative radiotherapy (except facial radiotherapy) are allowed.
* Randomisation in previous studies with NF, i.e. FT-016-IM, FT-017-IM or FT-018-IM, is not allowed.
* Previous use of Actiq is accepted.

Primary outcomes:
measure: Primary endpoint: Time to onset of meaningful pain relief recorded by stopwatch
timeFrame: 26 weeks
Secondary outcomes:
measure: • Pain Intensity Differences (PID) at 10 and 30 min derived from Pain Intensity (PI) scores • Sum of Pain Intensity Differences (SPID) 0-15 and 0-60 derived from PI scores • Time to 50% reduction in PI scores • General impression (GI) of the t
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Nycomed
Study officials:
affiliation: Headquaters
name: Nycomed Clinical Trial Operations
role: STUDY_CHAIR
References:
citation: Mercadante S, Radbruch L, Davies A, Poulain P, Sitte T, Perkins P, Colberg T, Camba MA. A comparison of intranasal fentanyl spray with oral transmucosal fentanyl citrate for the treatment of breakthrough cancer pain: an open-label, randomised, crossover trial. Curr Med Res Opin. 2009 Nov;25(11):2805-15. doi: 10.1185/03007990903336135.
Clinical trial NCT06377592: Development and Accuracy Evaluation of Gram Staining Analysis AI
Official title: Development and Accuracy Evaluation of Gram Staining Analysis AI
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bacterial Infections
Lead sponsor: GramEye
Sponsor class: INDUSTRY
First posted: 2024-04-22
Enrollment: 18000
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: Specimens for microbiological testing, such as Gram staining, ordered at the hospital.

Brief summary: The investigators use Gram-stained specimens provided from clinical settings to develop and evaluate the accuracy of Gram staining analysis AI


Eligibility criteria: Inclusion Criteria:

* Patients in whom a Gram stain test was ordered

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Advanced level of blood culture Gram stain analysis AI accuracy
timeFrame: Day1
measure: Ordinary level of blood culture Gram stain analysis AI accuracy
timeFrame: Day1
Secondary outcomes:
Other outcomes:
Locations:
city: Suita
country: Japan
facility: Osaka University Hospital
state: Osaka
Study officials:
affiliation: Osaka University Medical Hospital
name: Satoshi Kutsuna, PhD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00483392: Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: insulin
rosiglitazone
metformin
hiv
protease inhibitors
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2007-06-07
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate and compare the effects of treatment with rosiglitazone and metformin on insulin resistance in patients infected with Human Immunodeficiency Virus on stable Highly Active Antiretroviral Therapy including a Protease Inhibitor after the period of 48 weeks.


Eligibility criteria: Inclusion Criteria:

* documented HIV infection
* stable Protease Inhibitor containing HAART regimen for at least 12 months
* impaired glucose tolerance
* elevated insulin levels (above 20 mIU/l)

Exclusion Criteria:

* patients already taking oral hypoglycaemic treatment or insulin
* heart failure NYHA I-IV
* liver disease or kidney disease
* elevated AST or ALT above 2 times upper normal range
* elevated creatinine (above 150 mmol/l)

Primary outcomes:
measure: fasting plasma glucose, basal insulin levels
timeFrame: 48 weeks
Secondary outcomes:
measure: insulin resistance, beta cell function
timeFrame: 48 week
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Department of Endocrinology, Diabetes and Metabolic diseases
Study officials:
affiliation: Department of Endocrinology, Diabetes and Metabolic Diseases, Medical Center Ljubljana, Zaloska 7, 1525 Ljubljana, Slovenia
name: Andrej Janez, MD, PhD
role: STUDY_CHAIR
References:
citation: Silic A, Janez A, Tomazic J, Karner P, Vidmar L, Sharma P, Maticic M. Effect of rosiglitazone and metformin on insulin resistance in patients infected with human immunodeficiency virus receiving highly active antiretroviral therapy containing protease inhibitor: randomized prospective controlled clinical trial. Croat Med J. 2007 Dec;48(6):791-9. doi: 10.3325/cmj.2007.6.791.
Clinical trial NCT03335592: Cost of Off-label Antibiotics in Osteoarticular Infections
Official title: Cost of Off-label Antibiotics in Osteoarticular Infections: Prospective Study Over 2 Years in a Reference Center for the Management of Complex Bone and Joint Infection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bone Infection
Joint Infection
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-11-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having had off-label antibiotics to treat bone and/or joint infection, with or without implant

Brief summary: Due to the emergence of multidrug-resistant micro-organisms in patients with bone and joint infection (BJI), the prescription of off-labeled antibiotics seem to be more and more common as part of routine care. These new antibiotics are, however, more expensive, and there are no precise data in France regarding the volume and cost of such off-label prescriptions in hospital, in the post-acute care structures, and in the outpatient setting.

The objective of this study is to estimate the cost of using these antibiotics over 2 years for patients in a reference center for the management of complex bone and joint infection (CRIOAc)


Eligibility criteria: Inclusion Criteria:

- Patients having had off-label antibiotics between 2014 and 2015 to treat bone and/or joint infection, with or without implant and managed at the CRIOAc Lyon

Exclusion Criteria:

None

Primary outcomes:
measure: Estimation of the cost of the off-label antibiotics
timeFrame: 50 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre de Référence des Infections Ostéo-Articulaires complexes (CRIOAc Lyon)
Study officials:
References:
Clinical trial NCT02844192: Pharmacokinetics of Vancomycin in ICU Patients
Official title: Pharmacokinetics of Vancomycin in ICU Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Suspected Infection With Vancomycin Susceptible Bacterial Strains
Keywords: Vancomycin
under dosage
intensive care unit
pharmacokinetics
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 80
Sex: ALL
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: ICU patients

Brief summary: Vancomycin is frequently under-dosed in ICU patients during the first 24-48 hours of treatment. Glomerular hyperfiltration syndrome, increased drug volume of distribution, vasopressor use, male sex and hypoalbuminemia are identified risk factor for vancomycin underdosing in ICU patients, among others.

To date, bedside estimation of vancomycin volume of distribution is challenging, and new methods for optimizing drug administration are required.

The Picco device is a moderately invasive hemodynamic monitoring system, providing parameters that may help estimation of vancomycin pharmacokinetics parameter.

The aim of this study is to test whether addition of hemodynamic parameters would improve pharmacokinetics modelling of vancomycin concentration in ICU patients.


Eligibility criteria: Inclusion Criteria:

* patient hospitalized in intensive care unit
* under intravenous vancomycin started during current ICU hospitalization
* with at least one vancomycin serum concentration available
* under hemodynamic monitoring with the Picco ® device

Exclusion Criteria:

* vancomycin treatment for less than 24 hours
* vancomycin concentration in serum unavailable
* rare comorbidities influencing vancomycin pharmacokinetics

  * myeloma
  * cystic fibrosis
  * burn injury on more than 20 % of the body surface
* previous inclusion in present study

Primary outcomes:
measure: Akaike information criterion as a measurement of goodness of fit of pharmacokinetic modeling of vancomycin serum concentration
timeFrame: week 1
Secondary outcomes:
measure: Rate of patients with under-dosage of vancomycin at day 2 of treatment
timeFrame: day 2
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Hôpital de la Croix-Rousse - Réanimation, Surveillance Continue Médicales et Assistance Respiratoire,103 Grande Rue de la Croix-Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Jean-Christophe RICHARD, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04327492: Hemathologic and Imagiologic Predictors of Stroke During Carotid Endarterectomy With Regional Anesthesia
Official title: Clinical, Hematological, and Imagiologic Predictors of Postoperative Complications and Long Term Cardiovascular Events After Carotid Endarterectomy With Regional Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Stenosis
Carotid Endarterectomy
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients selected and submited to carotid endarterectomy under regional anesthesia

Brief summary: Establish and validate biomarkers which improve the predictive value of current risk stratification models for patients benefiting from carotid revascularization, outperform existing biomarkers, and reach clinical application standards.

Detailed description: The authors hypothesize FGF-23 and GDF-15 could predict cerebral ischemia, postoperative complications and long term major cardiovascular events, particularly in patients developing symptomatic neurologic ischemia after circulation shutdown.

Establish and validate biomarkers which improve the predictive value of current risk stratification models for patients benefiting from carotid revascularization, outperform existing biomarkers, and reach clinical application standards.

Clarify the pathophysiology of carotid endarterectomy-related stroke and the role of GDF-15, FGF-23, BNP and hs-troponin I and other biomarkers in the prognosis of symptomatic carotid stenosis.

Imagiologic markers are to be included - intima-media; gray weale plaque classification, cerebral CT Peak wave velocity

Eligibility criteria: Inclusion Criteria:

- consecutive patients from a tertiary referral center who undergo CEA for carotid artery stenosis (CS) under regional anesthesia

Exclusion Criteria:

* general anesthesia
* carotid stenting

Primary outcomes:
measure: Stroke
timeFrame: 30 days, long-term
measure: Clavien dindo>3
timeFrame: 30 days, long-term
measure: MACE
timeFrame: 30 days, long-term
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Faculdade de Medicina da Universidade do Porto
Study officials:
affiliation: Universidade do Porto
name: Joao R Neves, MD, MSC, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00275392: Vestibular Rehabilitation and Dizziness in Geriatric Patients
Official title: Vestibular Rehabilitation and Dizziness in Geriatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dizziness
Keywords: Dizziness
Geriatrics
Rehabilitation
Vestibular rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-01-11
Enrollment: 39
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to develop effective exercise intervention to reduce dizziness and fall risk in older adults with non-specific dizziness. We hypothesize that the use of vestibular exercises can reduce dizziness and improve gaze and postural stability in older persons.

Detailed description: Community dwelling older individuals who present to a specialty dizziness clinic (Atlanta VAMC or Emory University) with a primary complaint of dizziness will be recruited to participate in this study. Before beginning the study, the presence of normal vestibular function will be measured directly using standard vestibular function tests. Individuals will be randomly assigned to the vestibular exercise group (VR) or to the control group (CON). Data will be collected prior to the initiation of physical therapy and at the completion of the 6-week intervention period.

The VR group will perform vestibular exercises plus balance and gait exercises. The CON group will perform saccadic eye movements without targets against a blank wall, as well as balance and gait exercises. The balance and gait exercises for each group will be based on identified impairments and functional limitations, as is the standard of care in physical therapy. All subjects within a group will follow the same exercise progression for the vestibular or eye movement exercises. Subjects will be seen in the clinic on a weekly basis to review and modify the exercises according to a standard protocol and to reinforce compliance.

Eligibility criteria: Inclusion Criteria:

Patients must be at least 60 years of age, seeking medical care due to dizziness and have normal vestibular function based on results of the clinical examination, rotary chair and/or caloric tests.

Exclusion Criteria:

Abnormal vestibular function based on results of clinical examination, rotary chair and/or caloric tests.

Primary outcomes:
measure: Dynamic Gait Index
timeFrame: 6 weeks
Secondary outcomes:
measure: Dynamic Visual Acuity
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur
state: Georgia
Study officials:
affiliation: Mountain Home VA Medical Center James H. Quillen VA Medical Center, Mountain Home, TN
name: Courtney D. Hall, PhD PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hall CD, Heusel-Gillig L, Tusa RJ, Herdman SJ. Efficacy of gaze stability exercises in older adults with dizziness. J Neurol Phys Ther. 2010 Jun;34(2):64-9. doi: 10.1097/NPT.0b013e3181dde6d8.
Clinical trial NCT04185792: Polish Translation and Validation of NBSS, Qualiveen and SF-Qualiveen
Official title: Polish Translation and Validation of the Neurogenic Bladder Symptom Score (NBSS), Qualiveen and Short Form Qualiveen (SF-Qualiveen) Questionnaires
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Multiple Sclerosis
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
Collaborators: name: Piotr Chlosta, Full-time Professor, University Hospital, Cracow, Poland
First posted: 2019-12-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 200 patients with spinal cord injury and multiple sclerosis

Brief summary: The aim of this study is to translate, culturally adapt, and validate Polish versions of the NBSS, Qualiveen and SF-Qualiveen questionnaires.

Detailed description: The aim of this study is to translate, culturally adapt, and validate Polish versions of the NBSS, Qualiveen and SF-Qualiveen questionnaires in patients with spinal cord injury and multiple sclerosis.

Eligibility criteria: Inclusion Criteria:

* Spinal cord injury patients
* Multiple sclerosis patients
* Age \> 18

Exclusion Criteria:

* Spinal shock patients
* Urinary tract operation in the last month
* Quality of life changes in the last month
* Urinary tract infections in the last month
* Bladder management changes or drug changes in the last month

Primary outcomes:
measure: ICIQ-SF
timeFrame: 6 months
measure: Neurogenic Bladder Symptom Score Questionnaire (NBSS)
timeFrame: 6 months
measure: Qualiveen
timeFrame: 6 months
measure: Short Form Qualiveen (SF-Qualiveen)
timeFrame: 6 months
measure: The King's Health Questionnaire (KHQ)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Department of Urology Jagiellonian University
state: Malopolska
Study officials:
References:
citation: Przydacz M, Kornelak P, Golabek T, Dudek P, Chlosta P. Polish versions of the Qualiveen and the SF-Qualiveen: Translation and validation of urinary disorder-specific instruments in patients with multiple sclerosis. Neurourol Urodyn. 2020 Aug;39(6):1764-1770. doi: 10.1002/nau.24419. Epub 2020 Jun 16.
Clinical trial NCT00199992: Platelets in Acute Wounds: A Pilot Study (PAWS)
Official title: Platelets in Acute Wounds: A Pilot Study (PAWS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds
Keywords: acute wounds
wounds
platelets
platelet gel
Lead sponsor: Medtronic
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of wound healing treatments; platelet gel vs. control

Detailed description: Comparison of autologous platelet gel to a control treatment in acute wounds, specifically punch biopsy wounds. Eight patients included in this pilot/feasibility study. Wound healing evaluated over 6 months for wound closure and long term outcome.

Eligibility criteria: Inclusion Criteria:

Healthy non-smokers, \>18 years of age, BMI\<30 -

Exclusion Criteria:

Smokers, obese, keloid formers, bleeding disorders, medications -

Primary outcomes:
measure: Time to complete closure
Secondary outcomes:
measure: pain
measure: long-term scar appearance
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: DaVita Clinical Research
state: Minnesota
Study officials:
affiliation: Hennepin County Medical Center/ University of Minnesota
name: David HOM, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hom DB, Linzie BM, Huang TC. The healing effects of autologous platelet gel on acute human skin wounds. Arch Facial Plast Surg. 2007 May-Jun;9(3):174-83. doi: 10.1001/archfaci.9.3.174.