louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06635018: Effect of Pulse Oximeter Device on Measured Perfusion Index Values
Official title: Effect of Pulse Oximeter Device on Measured Perfusion Index Values
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Perfusion Index
Keywords: Perfusion index
Pulse oximetry
Nociception during Anesthesia
Lead sponsor: Czech Technical University in Prague
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional prospective single-arm study
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to experimentally determine the effect of pulse oximeters from different manufacturers on measured perfusion index values in healthy subjects at rest and with and without motion artifacts.

Detailed description: Perfusion index (PI) is one of the many vital signs monitored to assess the clinical status of a patient. PI is determined from the pulsatile part of the plethysmographic curve, with typical values measured on the fingers ranging from 0.02% to 20%. Although PI is a relatively newly measured parameter, it has already found application in many areas of clinical medicine. It can be used as an indicator of the severity of health status in different groups of critically ill patients, e.g. in patients with sepsis, in patients after cardiac arrest, for early detection of critical heart defects, for indirect assessment of patient pain, as an indicator of fluid therapy and reactivity, or for assessment and evaluation of anaesthesia in the operating room. However, there is currently no standardised calculation of PI and different manufacturers use different algorithms for the calculation. The consequence is that absolute measured values cannot be compared between devices.

Eligibility criteria: Inclusion Criteria:

* Healthy Adult Volunteer

Exclusion Criteria:

* Post-traumatic upper limb conditions affecting finger perfusion
* Injuries or diseases of the skin of the fingers
* Any acute phase of any disease

Primary outcomes:
measure: Comparison of Perfusion Index Values Measured by Pulse Oximeters From Different Manufacturers During Rest, Movement, and Circulatory Restriction
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Czech Technical University, Fac. of Biomedical Engineering
name: Karel Roubik, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT04835818: Point-of-Care Multiplex for Adult Patients With Severe Community-acquired Pneumonia
Official title: Clinical Impact on Point-of-Care Multiplex Polymerase Chain Reaction (PCR) Testing for Critically Ill Adult Patients With Community-acquired Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Community-acquired Pneumonia
Critical Illness
Keywords: Community-acquired Pneumonia
Critical Illness
Point-of-care
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Clinical Impact on Point-of-Care Multiplex PCR Testing for Critically Ill Adult Patients With Community-acquired Pneumonia - A cluster randomization study in ICU units within one medical center.

Detailed description: Point-of-Care Multiplex PCR Testing could narrow down the pathogens causing severe community-acquired pneumonia(CAP). Our hypothesis is that the result of Point-of-Care Multiplex PCR Testing could help primary physician to reduce antibiotics use.

Eligibility criteria: Inclusion Criteria:

* Adult patients (age \>20 y/o)
* ICU admission for acute respiratory failure due to community-acquired pneumonia by clinical diagnosis
* Treatment with endotracheal Intubation

Exclusion Criteria:

* Aspiration pneumonia (including witnessed aspiration and chronic bedridden status)
* Nosocomial infection

Primary outcomes:
measure: Intravenous antibiotic-free day within 14 days
timeFrame: up to 14 days
Secondary outcomes:
measure: ICU stay
timeFrame: up to 21 days
measure: Antibiotic-free day within 21 days
timeFrame: 21 days
measure: Intravenous antibiotic-free day within 21 days
timeFrame: up to 21 days
measure: Ventilator-free day within 28 days
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yu-Chung Chuang, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05340218: Short-term Automated Longitudinal Analysis of Speech and Language in Cognitive Impairment
Official title: "Análisis Longitudinal Del Habla y Seguimiento a Corto Plazo de Las Facultades Cognitivas de Personas Mediante Una Serie de Pruebas: Lista de Palabras CERAD, Repite Los dígitos en Orden Inverso, TMTA-B, Prueba Del Reloj, Fluidez fonémica, comprensión Verbal Relaciones semánticas, y semánticas Alternas".
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Dementia
Lead sponsor: Accexible
Sponsor class: INDUSTRY
First posted: 2022-04-22
Enrollment: 300
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Validate speech analysis AI models:

* To contrast the accuracy of acceXible's platform as a screening tool in the detection of people with cognitive impairment and mild dementia.
* To evaluate the correlation between automatically analyzed linguistic variables and a combination of standard measures of cognition.
* To assess short-term variability in language ability among older adults, and to assess which aspects of language vary during the study period.


Eligibility criteria: Inclusion Criteria:

* Adult patients 55+ years of age with suspected MCI or diagnosis of dementia and obtains a score greater than 20 on the MMSE.
* Patients must have agreed to participate in the study and have voluntarily signed the informed consent.
* (Healthy) Participants without a diagnosis neurological, or psychiatric disorders. Or taking medication that can affect cognitive abilities.

Exclusion Criteria

* To have received a diagnosis of a significant psychiatric disorder or other cognitive impairment not due to neurodegeneration.
* To have significant vision problems that would affect the ability to perceive visual stimuli.
* To have significant hearing problems that would affect the ability to understand verbal cues.

Primary outcomes:
measure: Pre-post variability of normal, MCI and dementia at both points of the study.
timeFrame: Change from the baseline cognitive function at 9 months.
Secondary outcomes:
measure: Correlation between cognitive tests and language variables obtained by the platform.
timeFrame: Every 6 to 9 months
Other outcomes:
measure: Accexible's model performance.
timeFrame: Every 6 to 9 months
Locations:
city: Madrid
country: Spain
facility: Centro de Prevención de Deterioro Cognitivo
Study officials:
References:
Clinical trial NCT01013818: A Study of HGS1029 in Subjects With Relapsed or Refractory Lymphoid Malignancies
Official title: A Phase 1, Multi-Center, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HGS1029 in Subjects With Relapsed or Refractory Lymphoid Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lymphoid Malignancies
Lead sponsor: Human Genome Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-16
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if HGS1029 is safe and well tolerated in patients with relapsed or refractory lymphoid malignancies.


Eligibility criteria: Inclusion Criteria:

* Confirmed relapsed/refractory lymphoid malignancies
* Previously treated with at least 2 therapeutic regimens
* ECOG performance \< 2.
* Life expectancy of at least 3 months
* Adequate renal function
* Adequate hematologic status
* Adequate liver function
* Transfusion independent

Exclusion Criteria:

* Received other therapy (biological or drug) to treat cancer within 4 weeks prior to starting treatment with HGS1029 or who exhibit persistent clinical evidence of cancer treatment toxicity
* The use of systemic corticosteroids within 1 week of starting treatment with HGS1029
* Evidence of active bacterial, viral or fungal infection within 2 weeks before starting treatment with HGS1029
* Known HIV infection
* Positive for hepatitis B surface antigen or positive hepatitis C antibody
* Grade 2 or greater neuropathy
* Pregnant female or nursing mother
* Males or females who do not agree to use effective contraception during the study and through at least 30 days after the last dose of HGS1029

Primary outcomes:
measure: Type, frequency and severity of adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Measure pharmacokinetic profile
timeFrame: 1st two months of the study
measure: Evaluation of pharmacodynamics
timeFrame: 1st two months of the study
measure: Evaluation of possible anti-tumor activity
timeFrame: Every 2 months while on study
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Headington
country: United Kingdom
facility: Oxford Cancer and Haematology Centre
state: Oxford
city: Belmont, Sutton, Surrey
country: United Kingdom
facility: The Institute of Cancer Research
city: Southampton
country: United Kingdom
facility: Cancer Research UK Centre
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01758718: Eyelash Line Resection for Entropion Associated With Down's Syndrome
Official title: Eyelash Line Resection for Entropion Associated With Down's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down's Syndrome
Keywords: Down's syndrome
entropion
lid plasty
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2013-01-01
Enrollment: 24
Sex: ALL
Minimum age (years): 3
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Surgical outcome of entropion associated with Down's syndrome was evaluated. Grading scale of superficial punctate keratopathy and score of wearing glasses to correct refractive errors were measured.


Eligibility criteria: Inclusion Criteria:

* The patients with entropion with Down's syndrome

Exclusion Criteria:

* The patients of Down's syndrome who do not have entropion.

Primary outcomes:
measure: Grading scale of superficial punctate keratopathy
timeFrame: one year
Secondary outcomes:
measure: Score of wearing glasses
timeFrame: one ear
Other outcomes:
Locations:
city: Mitaka
country: Japan
facility: Kyorin Eye Center
state: Tokyo
Study officials:
affiliation: Kyorin Eye Center
name: Akito Hirakata, MD
role: STUDY_CHAIR
References:
citation: Suzuki Y, Hama Y, Yoshikawa-Kobayashi I, Tomita K, Inoue M, Hirakata A. Eyelash line resection for cilial entropion in patients with Down's syndrome. Br J Ophthalmol. 2014 Oct;98(10):1442-7. doi: 10.1136/bjophthalmol-2014-304946. Epub 2014 May 15.
Clinical trial NCT06297018: Bioenergy, Depression, Anxiety and Stress After Liver Transplantation
Official title: The Effect of Bioenergy Application
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mental Health Issue
Keywords: Biyoenergy
anxiety
stress
liver transplant recipients
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Interventional Crossover Assignment
Primary purpose: BASIC_SCIENCE

Brief summary: In this study, the investigators aimed to examine the effect of bioenergy application on depression, anxiety and stress after liver transplantation.

Detailed description: Simple random sampling method was used to assign liver recipients to experimental and control groups. Discharged liver transplant patients will be investigated for anxiety, stress and depression.

Eligibility criteria: Inclusion Criteria:

(i) liver transplant recipient (ii) must be able to use immunosuppressive agents (iii) 18 years or older Liver transplant recipients

Exclusion Criteria:

having psychiatric problems having language and communication problems

Primary outcomes:
measure: Anxiety, stress, depression: Measurement will be made with the Depression Anxiety Stress 21 Scale (DASS-21: Score range 21-63)
timeFrame: total of six month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Semra Bulbuloglu
Study officials:
References:
Clinical trial NCT04144218: Evaluation of the Efficacy and Safety of Lacosamide in Pediatric Patients With Epilepsy
Official title: International Multicenter, Double-blind, Randomized, Placebo-controlled Evaluation of the Efficacy and Safety of Lacosamide in the Treatment of Pediatric Patients With Focal Refractory Epilepsy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Epilepsy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Tongji Hospital
name: Michigan State University
name: Juntendo University
name: Technical University of Munich
name: RIKEN
name: University of California, Los Angeles
First posted: 2019-10-30
Enrollment: 300
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children with focal refractory epilepsy will be routinely included in the collection of history, blood routine, biochemistry, EEG, MRI and 18F-FDG PET to determine the location of the epileptogenic focus and to assess the severity of the disease. This international multicenter clinical trial uses a double-blind, randomized, controlled study to evaluate the safety and efficacy of LCM in clinical applications in children with epilepsy.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of focal epilepsy with or without generalized seizures according to the 2017 International Association of Anti-Epilepsy (ILAE) classification criteria.
* Stable taking 1 or 2 other first-line anti-epileptic drugs for at least 10 weeks before screening visits.
* Seizure occurred during the 8-week retrospective baseline period with a complete medical record diary.

Exclusion Criteria:

* A history of status epilepticus within 3 months prior to screening visits.
* Poor adherence to previous treatment.
* Other serious organic diseases, mental illnesses and neurological diseases.
* Abnormal liver and kidney function and blood routine results.

Primary outcomes:
measure: Frequency of weekly seizures (times/week)
timeFrame: 16-week
measure: Assessment of liver function by serum alanine aminotransferase (U/L)
timeFrame: One year
measure: Assessment of renal function by serum creatinine (umol/L)
timeFrame: One year
measure: Assessment of white blood cell count ( /L)
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT01038518: Health2010-14: Monitoring Biomarkers of Chronic Diseases in the General Population
Official title: Health2010-14: Monitoring Biomarkers of Chronic Diseases in the General Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Type 2 Diabetes
Asthma
Allergy
Osteoporosis
Keywords: epidemiology
risk factors
micronutrients
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: Steno Diabetes Centre, Gentofte, Denmark
First posted: 2009-12-24
Enrollment: 1522
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Random samples of persons living in 10 municipalities in the Western part of the Capital Region of Denmark (Copenhagen).

Brief summary: The overall aim of the Health2010-14 is to monitor the prevalence and trends of common chronic diseases (osteoporosis, diabetes, cardiovascular disease, asthma, allergy, and eczema) that are often un-diagnosed in the general population as well as biomarkers of micronutrient status. Specific aims include identification of novel lifestyle and genetic risk factors for the above diseases by investigating gene-lifestyle interactions.

Detailed description: Over a 5-year period a series of population-based studies are carried out including a total of up to 10,000 persons aged 18-69 years selected from the general population of Copenhagen, Denmark. The study also include a follow-up of a previous population study (the Health2006). Participants complete questionnaires on health, lifestyle, and social factors and undergo a health examination including measurements of metabolic biomarkers, allergy tests, anthropometric measures, bioimpedance, biomarkers of micronutrients, spirometry.

Eligibility criteria: Inclusion Criteria:

* persons living in 10 municipalities of Copenhagen

Exclusion Criteria:

* pregnancy, non-Danish citizenship

Primary outcomes:
measure: 5-year change in prevalence of biomarkers of chronic diseases (e.g. diabetes, asthma, allergy) and micronutrient status (e.g. vitamin D status).
timeFrame: 5 years
Secondary outcomes:
measure: significant interaction (on a additive scale) between Vitamin D status and genetic variants in the Vitamin D receptor in relation to selected chronic disease biomarkers
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Research Center for Prevention and Health, Glostrup Hospital
name: Allan Linneberg, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00140218: R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis
Official title: Futility Study of R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Keywords: amyotrophic lateral sclerosis
pramipexole
oxidative stress
neuroprotection
Lead sponsor: Bennett, James P., Jr., M.D., Ph.D.
Sponsor class: INDIV
Collaborators: name: University of Pittsburgh
First posted: 2005-09-01
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The hypothesis of this study is that treatment with R(+) pramipexole at 30 mg/day will alter the slope of decline in ALS functional rating scale over the course of 6 months. ALS patients at an early stage of disease will be observed for 3 months after enrollment and then treated with drug for 6 months.

Detailed description: This is a futility design Phase II study using ALS-FRSr as the primary variable to monitor progression of disease in patients with early ALS. The drug to be tested is R(+) pramipexole, an antioxidant that concentrates into brain and mitochondria. R(+)PPX will be administered at 30 mg/day over 6 months, following a 3 month lead-in period without drug therapy. For purposes of this study, futility is defined as failure to decrease the slope of ALS-FRSr decline by less than 40%.

Eligibility criteria: Inclusion Criteria:

* established diagnosis of ALS FVC\>60% of predicted not being ventilated no difficulty swallowing ambulatory (can use assistance devices)

Exclusion Criteria:

* ALS duration \>3 years advanced ALS with survival predicted \<6 months dementia (MMSE\<22) prior exposure to R(+) pramipexole orthostatic hypotension \>30 mmHg history of psychosis or hallucinations abnormal baseline safety lab values

Primary outcomes:
measure: ALS-FRSr score taken each month for 3 months during lead-in and for 6 months during treatment
timeFrame: -3 -2 -1 0 1 2 3 4 5 6 months
Secondary outcomes:
measure: FVC taken each month
timeFrame: -3 -2 -1 0 1 2 3 4 5 6 months
measure: hand dynamometry taken each month
timeFrame: -3 -2 -1 0 1 2 3 4 5 6
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: David Lacomis MD
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Lawrence H Phillips, M.D.
role: PRINCIPAL_INVESTIGATOR
References: