louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01448694: Non-invasive Hemodynamic Monitoring During Blood Donation for Developing Models of Early Blood Loss
Official title: Non-invasive Hemodynamic Monitoring During Blood Donation for Developing Models of Early Blood Loss.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Keywords: Hemorrhage
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2011-10-07
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: This study is part of a Phase II STTR project to develop an algorithm called CipherSensor to apply feature extraction and machine learning techniques to non-invasive hemodynamic data to identify early signs of acute blood loss. The availability of this information may help to establish required interventions for treating trauma patients and battlefield casualties.

Study hypothesis: Hemodynamic changes measured non-invasively during the blood donation process can be modeled to provide early estimations of blood loss.


Eligibility criteria: Inclusion Criteria:

* Approved by Children's Hospital Colorado Blood Donation Center for blood donation
* Age 18 -89 years
* Previously donated blood (lower likelihood of vasovagal response)

Exclusion Criteria:

* Pregnant
* Incarcerated
* Limited access to or compromised monitoring sites for non-invasive sensors: finger, ear and forehead sensors, oral/nasal cannula, 3 ECG electrodes.

Primary outcomes:
measure: Algorithm
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado
name: Steve Moulton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00374894: The Combined Effect of 2,3-Dimercaptosuccinic Acid and Multi-Nutrients on Children in Lead Poisoning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lead Poisoning
Keywords: 2,3-dimercaptosuccinic acid
Blood Lead Levels
children
multi-nutrients
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2006-09-12
Enrollment: 500
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Lead poisoning remains a common disease among children despite successful public health efforts that reduced its prevalence.Our study was designed to test the hypothesis that lead-poisoning children (BLLs:100-440µg/L) who were given DMSA and multi-nutrients would have a greater fall than children of other groups at 12 weeks of follow-up.


Eligibility criteria: Inclusion Criteria:

* Initial BLLs 100-440µg/L
* Age 3-6y
* No more than two main residences
* House cleaned (no lead contaminated)
* Normal intake history and physical

Exclusion Criteria:

* Chelation in the past 12 weeks
* Concomitant Fe deficiency(ferritin\<16ng/ml)
* Hemoglobin\<10.5g/dL
* Medications affecting mineral metabolism

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: China Medical University
state: Liaoning
Study officials:
affiliation: Department of Environmental and Occupational Health
name: Jin Ya ping, professor
role: STUDY_DIRECTOR
References:
citation: CDC．Preventing lead poisoning in young children［R］. U.D.Dept of health and Human services 1991:1.
Clinical trial NCT02592694: Intracoronary Cocktail Injection Combined With Thrombus Aspiration in STEMI Patients Treated With Primary Angioplasty
Official title: Intracoronary Cocktail Injection Combined With Thrombus Aspiration in ST-elevation Myocardial Infarction Patients Treated With Primary Angioplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: ST-elevation Myocardial Infarction
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2015-10-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, double blind, placebo controlled study of intracoronary cocktail injection combined with thrombus aspiration versus thrombus aspiration alone in ST-elevation myocardial infarction patients treated with primary angioplasty.

Detailed description: This is a randomized, double blind, placebo controlled study of intracoronary cocktail injection combined with thrombus aspiration versus thrombus aspiration alone in ST-elevation myocardial infarction patients treated with primary angioplasty. Patients with STEMI will be randomized into the cocktail group or the control group. Patients in the cocktail group will receive cocktail injection combined with thrombus aspiration. Patients in the control group will receive thrombus aspiration alone. The primary outcome of the cocktail I study is the composite of death, myocardial infarction or class IV heart failure within 1 year. The secondary outcome of the cocktail I study include slow reflow/no reflow during PCI, left ventricular function, quality of life, stroke or life-threatening bleeding within 1 year.

Eligibility criteria: Inclusion Criteria:

* 18-80 years of age adult patients with STEMI Referred for primary PCI within 5d of symptom onset

Exclusion Criteria:

* Patients who had undergone previous coronary artery bypass surgery or PCI or had received fibrinolytic therapy History of stroke Active bleeding Severe hepatic or renal dysfunction Cardiogenic shock Contraindications for primary PCI or DAPT

Primary outcomes:
measure: Death, Mayocardial infarction, NYHA Ⅳ heart failure
timeFrame: 1 year
Secondary outcomes:
measure: Slow reflow/no reflow
timeFrame: intraoperative
measure: Left ventricular function
timeFrame: 1 year
measure: Seattle Angina Questionnaire scores
timeFrame: 1 year
measure: Canadian Cardiovascular Society (CCS) Functional Angina classification
timeFrame: 1 year
measure: 6-minute walk distance (6MWD)
timeFrame: 1 year
measure: Stroke
timeFrame: 1 year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hospital
state: Shaanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Dongdong Sun, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03692494: The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy
Official title: The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Dysphonia
Unilateral Vocal Cord Paralysis
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 0
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: Evaluate if adding expiratory muscle strength training to traditional voice therapy for individuals with dysphonia due to glottal insufficiency improves maximal expiratory pressure, acoustic and aerodynamic measures (i.e. amplitude, maximum phonation time, peak expiratory flow), and voice related quality of life.


Eligibility criteria: Inclusion Criteria:

* Individuals with glottic insufficiency.
* Adequate cognition evidenced by score of 24 or higher on the Mini-Mental State Examination (MMSE) survey to determine if the subject has the mental capacity to participate in therapy
* Completed voice combination evaluation with speech pathologists and otolaryngologist.
* Individuals 18 years of age or older

Exclusion Criteria:

* Adults unable to consent
* Non English or Spanish speakers
* Pregnant women
* Prisoners
* Individuals with significant uncontrolled chronic and progressive respiratory diseases including COPD, interstitial lung disease, and cystic fibrosis.
* Individuals with uncontrolled blood pressure.
* Individuals with significant GI disease and/or gastroesophageal surgery with the exception of well-controlled GERD.
* Individuals with a history of abdominal hernia.
* Individuals with difficulty complying due to neuropsychological dysfunction (e.g., severe depression, psychosis).
* Individuals with other neurological disorders and/or neuromuscular disease other than Parkinson's Disease

Primary outcomes:
measure: Maximum expiratory pressure
timeFrame: 16 weeks
measure: Amplitude
timeFrame: 16 weeks
Secondary outcomes:
measure: Fundamental frequency
timeFrame: 16 weeks
measure: Dynamic pitch range
timeFrame: 16 weeks
measure: Cepstral Peak Prominence (CPP)
timeFrame: 16 weeks
measure: Cepstral spectral index of dysphonia (CSID)
timeFrame: 16 weeks
measure: Voice Handicap Index
timeFrame: 16 weeks
measure: Maximum phonation time
timeFrame: 16 weeks
measure: Peak expiratory flow rate
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Adam T Lloyd, SLP-D, MM, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03994094: Three Year Evaluation of a Cohort of Patients Presenting Osteoporotic Fractures
Official title: Three Year Evaluation of a Cohort of Patients Presenting Osteoporotic Fractures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Osteoporotic Fractures
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 147
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: All patients who were enrolled in the cohort of the osteoporosis clinic of our hospital between january 2012 and December 2015 following an osteoporotic fracture.

Brief summary: A specialized osteoporosis clinic has existed in our hospital since 2010. The descriptive retrospective analysis of patients included in this pathway was the subject of a first study on patients included between January 2010 and January 2011 and reported to the Congress of the French Society of Rheumatology (SFR) in December 2011, then a second study on patients included between January 2012 and December 2016, presented as an e-poster at the SFR Congress in December 2017 and in a poster at the American Society of Bone and Mineral Research Conference (ASBMR) in October 2018 and published in 2019 in Archives of Osteoporosis.

The effectiveness specialized osteoporosis clinics is the subject of numerous publications.

It therefore seems important to evaluate the effectiveness of our management, 3 years from the date of inclusion of patients in the osteoporosis clinic of our hospital.


Eligibility criteria: Inclusion Criteria:

* Patients who had an osteoporotic fracture followed by the osteoporosis clinic since between January 2012 and December 2015
* Acceptation of the telephone interview

Exclusion Criteria:

* Age \< 18 years
* No social security coverage

Primary outcomes:
measure: Number of fractures since the enrollment in the clinic
timeFrame: From the enrollment of patients between january 2012 and december 2015 to the interview date
Secondary outcomes:
measure: Evolution of bone mineral density since the enrollment in the clinic
timeFrame: From the enrollment of patients between january 2012 and december 2015 to the interview date
measure: Satisfaction with the osteoporosis clinic
timeFrame: From the enrollment of patients between january 2012 and december 2015 to the interview date
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
Study officials:
affiliation: Centre Hospitalier du Mans, Rheumatology Department
name: Bénédicte Haettich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01154660: Effects of Increased Tidal Volume on Internal Jugular Vein Cross-sectional Area
Official title: Effects of Increased Tidal Volume on Internal Jugular Vein Cross-sectional Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Surgery
Keywords: any operation that required for general anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-07-01
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: As increasing tidal volume, the cross sectional area and circumference of Internal Jugular Vein (IJV) could increase. And In the previous study, Trendelenburg position can increase size of IJV. So investigators would compare the cross sectional area, circumference of IJV and peak airway pressure in neutral and Trendelenburg position


Eligibility criteria: Inclusion Criteria:

* patients who are undergoing general anesthesia

Exclusion Criteria:

* history of IJV cannulation
* uncontrolled cardiovascular disease
* severe pulmonary problem
* cervical spinal impairment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Anesthesiology & Pain Medicine
Study officials:
References:
Clinical trial NCT00785460: Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers
Official title: Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Subjects
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2008-11-05
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Benfotiamine pretreatment (3 days)at high dosage (1050 mg/day) prevents in healthy subjects smoking-induced vascular dysfunction assessed by ultrasound flow mediated dilatation of the brachial artery.

Detailed description: Benfotiamine pretreatment (3 days)at high dosage (1050 mg/day) prevents in healthy subjects smoking-induced vascular dysfunction assessed by ultrasound flow mediated dilatation (FMD) of the brachial arteryand laboratory parameters (adhesion molecules).

Eligibility criteria: Inclusion Criteria:

* healthy habitual smokers

Exclusion Criteria:

* any kind of chronic disease

Primary outcomes:
measure: Flow mediated dilatation
timeFrame: 3 days
Secondary outcomes:
measure: Laboratory markers of endothelial function
timeFrame: 3 days
Other outcomes:
Locations:
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Center
state: NRW
Study officials:
affiliation: Ruhr-University Bochum
name: Alin Stirban, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05559060: Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)
Official title: Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epilepsy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects included will be chosen from epilepsy clinic and neurology department at assiut University hospital

Brief summary: Epilepsy is the second commonest chronic neurological disorder in developed countries ,comorbidity refers to the co-occurrence of two conditions with greater frequency than found in the general population


Eligibility criteria: Inclusion Criteria:

Patients with primary epilepsy. Aged above 18 years old.

Exclusion Criteria:

* patient diagnosed as secondary epilepsy or epilepsy syndromes

Primary outcomes:
measure: Find out comorbidities of epilesy and its treatment
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00489060: A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Localized Prostate Cancer
Official title: A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Clinically Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: Cryoablation
Radiation
Prostate Cancer
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Trials Group
name: AHS Cancer Control Alberta
First posted: 2007-06-21
Enrollment: 244
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A trial to determine if cryoablation is as effective as radiation in the treatment of men with localized prostate cancer.

Detailed description: Men with newly diagnosed localized prostate cancer were randomly assigned to cryoablation or external beam radiotherapy (median dose 68 Gy). All patients received neoadjuvant antiandrogen therapy. The primary endpoint was disease progression at 36 months based on a trifecta definition of failure: (a) radiological evidence of metastatic disease or b) initiation of further antineoplastic therapy or c) biochemical failure). Two definitions of biochemical failure were used: 1) rising PSA with a final value \>1.0 ng/mL and 2) rise above PSA nadir + 2 ng/mL. Secondary endpoints were overall survival, disease-specific survival, and positive prostate biopsy at 36 months.

Eligibility criteria: Inclusion Criteria:

* Clinically localized prostate cancer
* PSA \< 20ng/ml
* Negative bone scan

Exclusion Criteria:

* Previous TURP
* Previous hormone therapy

Primary outcomes:
measure: No evidence of disease progression (NEDP) at 36 months
timeFrame: 36 months
Secondary outcomes:
measure: Prostate biopsy status
timeFrame: 36 months post treatment
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
Study officials:
affiliation: Tom Baker Cancer Center
name: Bryan Donnelly, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00322660: Adrenaline Injections to Children Born at Elective CS
Official title: Can the Risk of RD and Hypoglycemia in Children Born at Elective CS be Reduced by Injection of Adrenaline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress
Hypoglycemia
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2006-05-08
Enrollment: 270
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Children born after elective C-section have a greater risk of respiratory problems and hypoglycemia - most likely due to a lower concentration of stress hormones compared to children born vaginally. Hypothesis: can we eliminate or reduce the risk of respiratory distress and hypoglycaemia by administrating adrenaline to the newborn.


Eligibility criteria: Inclusion Criteria:

* All children born at elective section with gestational age more than 37 + 0

Exclusion Criteria:

* Children in whom a serious malformation was found during pregnancy assuming this malformation will lead to very early death or respiratory problems.
* Serious malformations (ex.anencephalia) will be excluded at birth
* Other malformations will be estimated by investigator whether it will lead to exclusion.

Primary outcomes:
measure: respiratory distress
measure: hypoglycemia
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre University Hospital
state: Hvidovre
city: Kettegård Alle 31
country: Denmark
facility: Hvidovre Hospital
state: Hvidovre
Study officials:
affiliation: Hvidovre University Hospital, Copenhagen, Kettegaards allé 30, 2650 Hvidovre, DK
name: Lene A Olsen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hvidovre University Hospital
name: Pernille Pedersen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Irestedt L, Lagercrantz H, Belfrage P. Causes and consequences of maternal and fetal sympathoadrenal activation during parturition. Acta Obstet Gynecol Scand Suppl. 1984;118:111-5. doi: 10.3109/00016348409157136.
citation: Pedersen P, Avlund OL, Pedersen BL, Pryds O. Intramuscular adrenaline does not reduce the incidence of respiratory distress and hypoglycaemia in neonates delivered by elective caesarean section at term. Arch Dis Child Fetal Neonatal Ed. 2009 May;94(3):F164-7. doi: 10.1136/adc.2008.138487. Epub 2008 Sep 11.
Clinical trial NCT01735760: Ultrasound Examination Versus Palpation to Locate the Cricothyroid Membrane
Official title: Comparison of Ultrasound Examination and Palpation to Locate the Cricothyroid Membrane - a Randomized Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focus: Localizing the Cricothyroid Membrane Before Airway Management
Keywords: airway management
cricothyroid membrane
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2012-11-28
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: anesthesiologists

Brief summary: Anesthesiologists get a course on localizing the cricothyroid membrane on a human using ultrasonography. Thereafter their ability to localize the cricothyroid membrane with either palpation or ultrasonography, in a randomised fashion, is tested.

Detailed description: The ability to localize the cricothyroid membrane on patients before airway management is crucial in order to be able to follow the difficult airway algorithms.

Studies have show a high failure rate when anesthesiologists rely on palpation.

In this study Anesthesiologists get an e-learning course, get literature to study , and get a theoretical course and a hands-on course in using ultrasound for localizing the cricothyroid membrane. . Thereafter their ability to localize the cricothyroid membrane with either palpation or ultrasonography, in a randomised fashion, is tested.

Eligibility criteria: Inclusion Criteria:

* being an anesthesiologist attending our airway management course

Exclusion Criteria:

* unwillingness to participate

Primary outcomes:
measure: rate of success of localizing the cricothyroid membrane with ultrasound and palpation
timeFrame: december 2012
Secondary outcomes:
measure: time to localise the cricothyroid membrane with ultrasonography and palpation
timeFrame: december 2012
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Denmark
Study officials:
References: