louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04241757: Electrocardiogram in General Practice : the EGG Study
Official title: Electrocardiogram in General Practice : the EGG Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Indication for ElectroCardioGram
Keywords: ElectroCardioGram
General practice
Diagnosis
Signs and symptoms
Feasibility studies
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Association CNGE IRMG
First posted: 2020-01-27
Enrollment: 888
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with indication of ElectroCardioGram (ECG) will be included.

Brief summary: Existing resources to assist interpretation of ElectroCardioGram (ECG) in general practice provide specialized and comprehensive reading based on pathologies and ElectroCardioGram (ECG) signs rather than ElectroCardioGram (ECG) indications.

Describing practices in general medicine could help prioritize the relevance of clinical and ECG signs for the general practitioner, enabling to adjust the reading given the context.

Detailed description: The primary objective of this study is to describe the clinical signs and ElectroCardioGram (ECG) in situations indicating an ElectroCardioGram (ECG) in general practice.

Eligibility criteria: Inclusion Criteria:

* Patient consulting one of the generalist practitioner investigators
* In doctor's office or at home, scheduled or not,
* During normal surgery hours or out-of-hours service,
* Whatever the reason for consultation,
* Aged 18 years or older,
* Having an indication of ElectroCardioGram (ECG) and/or request certificate of non-contra-indication to the practice of physical activity certificate of non-contra-indication to the practice of physical activity

Exclusion Criteria:

* ElectroCardioGram (ECG) not performed due to emergency context
* Patient with cognitive impairment who cannot give consent to participate in the study and / or patient under guardianship

Primary outcomes:
measure: Description of clinical signs
timeFrame: day 0
measure: Description of clinical signs ElectroCardioGram (ECG) sign
timeFrame: day 0
Secondary outcomes:
measure: Difficulties in carrying out the Electrocardiogram
timeFrame: Day 0
measure: Initial management types
timeFrame: Months 1
measure: Diagnosis types
timeFrame: Months 1
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Association CNGE IRMG
Study officials:
affiliation: CHU DE SAINT-ETIENNE
name: Paul FRAPPE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04153357: Comparison of Different Video Laryngoscopes in < 1 Year Old Undergoing Neurosurgical Operations: a Prospective Randomized Study
Official title: Comparison of Airtraq and C-mac in Pediatric Patients Under 1 Year Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation;Difficult
Keywords: airtraq
c-mac
videolaryngoscope
infant
intubatioon
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: İntubation of pediatric patients is a challenging problem. Video laryngoscopes increased the intubation success rate. We want to compare different video laryngoscopes in this field.

Detailed description: Aim:İntubation of pediatric patients is a challenging problem. Video laryngoscopes increased the intubation success rate. We want to compare different video laryngoscopes in this field.

methods: We enroll total 50 patients \< 1 year old undergoing neurosurgery. We compared the intubation times, success rates and minor complications of Airtraq and c-mac video laryngoscopes in these pediatric patients undergoing neurosurgery.

Eligibility criteria: Inclusion Criteria:

\< 1 years old

* undergoing neurosurgery ASA 1-2

Exclusion Criteria:

* \> 1 year old
* asa 3-4
* emergency

Primary outcomes:
measure: intubation time
timeFrame: 30 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University Medical Faculty
Study officials:
References:
Clinical trial NCT04681157: Retrospective Study on Anosmias and Ageusias Linked to Infection by Covid-19
Official title: Retrospective Study on Anosmias and Ageusias Linked to Infection by SARS-Cov 2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
Keywords: Covid-19
Odor disturbance
Taste disturbances
SARS-Cov2
Anosmia
Ageusia
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 300
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: Adult patient having had a loss of smell and / or taste that occurred during the period of the Covid-19 epidemic with or without other symptom (s) suggestive of a Covid infection -19

Brief summary: Odor and taste disturbances have increased dramatically during this time of the COVID-19 pandemic. Currently, we have very little information on the demographic and clinical characteristics of the affected population, on the severity and course of the olfactory / taste loss.

The main objective of this research is to analyze the epidemiological, demographic and clinical characteristics of patients suspected or already confirmed of infection with SARS-Cov2 presenting with anosmia and / or ageusia.


Eligibility criteria: Inclusion Criteria:

* Major subject (≥18 years old)
* Subject having had a loss of smell and / or taste that occurred during the period of the Covid-19 epidemic with or without other symptom (s) suggestive of a Covid infection -19
* Subject with suspected or confirmed Covid-19 infection
* Subject taken care of by the ENT service
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion Criteria:

* Subject having expressed opposition to participating in the study
* Subject under guardianship or guardianship
* Subject under safeguard of justice

Primary outcomes:
measure: Retrospective analysis of demographic and clinical characteristics of patients with suspected or already confirmed SARS-Cov2 infection with anosmia and / or ageusia
timeFrame: The files analysed retrospectily from February 01, 2020 to June 03, 2020 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Strasbourg University Hospitals - Otorhino-Laryngology Department
state: Starsbourg
Study officials:
References:
Clinical trial NCT02746666: Pharmacist's Influence on Breast Cancer Patient Quality of Life
Official title: Influence of a Clinical Pharmacist's Intervention on Quality of Life of a Breast Cancer Patient Under Adjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer, Quality of Life
Lead sponsor: University Hospital Sestre Milosrdnice
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the impact of pharmacist behavioral intervention's influence on breast cancer patients' quality of life. Croatian randomized controlled trial. Targeted population: general population of breast cancer patients under the first adjuvant anthracycline chemotherapy. Primary outcome: difference in EORTC QLQ-BR23 questionnaire result from the baseline to after 3 week cycle.


Eligibility criteria: Inclusion Criteria:

* Early breast cancer
* First adjuvant chemotherapy
* Chemotherapy protocol: anthracycline x 4

Exclusion Criteria:

* Cardiovascular comorbidities
* Regular nausea or vomiting during six months before enrollment
* Unable to answer the quality of life questionnaire on their own

Primary outcomes:
measure: changes in quality of life of a breast cancer patient under chemotherapy, after a clinical pharmacist's behavioral intervention, measured by EORTC B23 questionnaire
timeFrame: up to two months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03568266: Pharmacogenomics of Asparaginase Induced Hepatotoxicity
Official title: Pharmacogenomics of Age-Specific, Asparaginase-Induced Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Lymphoblastic Leukemia
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-06-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed with Acute Lymphoblastic Leukemia (ALL) who are seen at USC facilities will be recruited.

Brief summary: This pilot trial studies the impact of genetic information on developing liver damage caused by asparaginase in participants with newly diagnosed acute lymphoblastic leukemia. Testing saliva samples may help doctors find certain genetic markers that may predict whether participants will tolerate asparaginase, which is given as part of clinical care for acute lymphoblastic leukemia.

Detailed description: PRIMARY OBJECTIVES:

I. To establish the association between the SOD2 rs4880 genotypes and asparaginase-induced hepatotoxicity in Hispanic patients.

II. To identify novel single nucleotide polymorphisms (SNPs) that are associated with asparaginase induced hepatotoxicity.

OUTLINE:

Participants' SOD2 rs4880 SNP genotype (based on saliva from buccal swabs) will be classified. Participants with the CC genotype will be compared to participants with the CT or TT genotype. Buccal swabs of prospective participants' saliva will be collected when participant achieves complete remission (during regular clinical visit). Retrospective participants will be identified through search of pharmacy records for those who received asparaginase within the last 5 years (2012-2017). Recurrent patients will be consented during their regular clinical visits and samples will be collected.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed with acute lymphoblastic leukemia (ALL) - no prior treatment for ALL
* Receiving asparaginase as part of the primary treatment regimen
* Ability to understand and the willingness to sign a written informed consent
* For retrospective recruitment, those who have received asparaginase between 2012 and 2017; and are current patients of University of Southern California (USC)

Exclusion Criteria:

* Patients who are unable to give informed consent

Primary outcomes:
measure: Hepatotoxicity following treatment with asparaginase
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC / Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Houda Alachkar, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00005766: Clinical Trial of Creatine in Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Keywords: ALS
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-06-02
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine whether creatine slows disease progression in subjects with amyotrophic lateral sclerosis (ALS). ALS is a progressive uniformly lethal neurodegenerative disorder for which there is no known cure. Recent genetic and biochemical studies implicate free radical toxicity, glutamate excitotoxicity and mitochondrial dysfunction as possible causes of familial ALS (FALS) and sporadic ALS (SALS). It has been hypothesized that in ALS there may be involvement of oxidative free radical damage and impaired mitochondrial energy metabolism that could in turn lead to excitotoxic cell death. Creatine, an agent that improves mitochondrial function, has been shown to be neuroprotective in animal models of ALS and Huntington's disease.

This study is a double-blind, randomized, placebo-controlled trial of the safety and efficacy of creatine in patients with ALS enrolled at sites distributed throughout the United States, including Northeast ALS (NEALS) sites. The study will provide preliminary data on the safety and efficacy of creatine in ALS. If creatine slows disease progression in ALS and is well tolerated, a phase 3 study with survival as the primary outcome measure will be initiated.

114 eligible subjects will be randomized to receive treatment for 6 months of (1) active creatine or (2) placebo. After randomization, subjects will be followed prospectively for 6 months. The primary outcome measure for the study is the change in upper extremity motor function after 6 months of experimental therapy as tested with the Tufts Quantitative Neuromuscular Exam. Strength in eight arm muscles will be measured (bilateral shoulder and elbow flexion and extension). Secondary outcome measures include grip strength, motor unit number estimates (MUNE), the ALS functional rating score-revised (ALSFRS-R), and rate of change of a well established biochemical marker of oxidative damage to DNA (8OH2'dG levels in urine), and the safety and tolerability of creatine.


Eligibility criteria: Inclusion Criteria:

* ALS
* FVC \>=50%
* Abnormality in upper and/or lower extremity motor function
* Not pregnant
* Disease duration \<5 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
References:
Clinical trial NCT01908166: Ultrasound Elastography in Diagnosing Patients With Kidney or Liver Solid Focal Lesions
Official title: US Elastography for Characterizing Focal Lesions in the Liver and Kidney
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Primary Liver Cancer
Kidney Tumor
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-07-25
Enrollment: 61
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical trial studies ultrasound elastography in diagnosing patients with kidney or liver solid focal lesions. New diagnostic procedures, such as ultrasound elastography, may be a less invasive way to check for kidney or liver solid focal lesions.

Detailed description: PRIMARY OBJECTIVES:

I. To determine the utility of ultrasound elastography in correlation with kidney or liver biopsy or magnetic resonance imaging (MRI) or computed tomography (CT) results.

OUTLINE:

Patients undergo ultrasound elastography.

Eligibility criteria: Inclusion Criteria:

* There are no restrictions on life expectancy
* Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status will not be employed
* Patients of any ethnic background
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients should not be taking other investigational agents
* No requirements due to co-morbid disease or intercurrent illness, as needed
* No restrictions on allergic reactions as no imaging agent will be used
* Concomitant medications for treatment of the target lesion
* Pregnant or nursing patients will be excluded from the study

Primary outcomes:
measure: Strain ratio for all lesions measured by comparing the lesion to the adjacent normal tissue
timeFrame: Up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University Hospitals and Clinics
name: Juergen Willmann
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00518466: Pharmacokinetic Comparison of Multiple Formulations of Topiramate and Phentermine in Obese Adults
Official title: A Phase Ib, Open Label, Parallel-Design Single- and Multiple-Dose Study Comparing Modified Release Topiramate Formulations to Immediate Release Formulations of Topiramate Dosed in Combination With Immediate Release Phentermine in Obese Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: Obesity
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
First posted: 2007-08-20
Enrollment: 64
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to describe the single- and multiple-dose pharmacokinetic profiles of two novel formulations of topiramate and commercially available immediate release topiramate, all dosed with immediate release phentermine.


Eligibility criteria: Inclusion Criteria:

* Obese adults
* Body mass index between 30.0 and 42.0 kg/m2 (inclusive)
* Medically healthy with no clinically significant results of screening exams

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
* History of glaucoma or increased intraocular pressure
* History of kidney stones
* Cholelithiasis or cholecystitis within 6 months
* Cardiovascular event within 6 months
* Obesity of known genetic or endocrine origin
* Recent weight instability
* Use of Very Low Calorie diet or participation in organized weight loss program within 3 months
* Systolic blood pressure \> 150 or diastolic \> 95 mm Hg
* Positive urine drug or alcohol screen
* Positive serology for HIV, HBV, or HCV
* History of alcoholism or drug abuse
* History of significant psychiatric disease, current depression of moderate or greater severity, any history of suicidal ideation
* Hypersensitivity to study drug or related compounds
* Use of prescription or OTC medication other than hormonal contraceptive within 14 days prior to first dosing with study drug
* Blood donation or significant blood loss within 56 days or plasma donation within 7 days prior to first dosing with study drug
* Women who are pregnant or lactating
* Hemoglobin \< 12 g/dL
* Use of tobacco or nicotine-containing products within 6 months

Primary outcomes:
measure: Pharmacokinetic parameters
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: VIVUS, Inc.
state: California
Study officials:
affiliation: VIVUS LLC
name: Wesley W Day, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02747966: The Relationship Between the Flow of Arteriovenous Fistula and Cardiac Function in Haemodialysis Patients
Official title: Study of Access Flow ,Access Recirculation of Arteriovenous Fistula and the Relationship With Cardiac Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Hemodialysis
Keywords: access flow
access recirculation
cardiac output
cardiac index
hemodialysis
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All eligible participants are recruited according the inclusion and exclusion criteria.Their basis data are documented and the central hemodynamic condition are assess cross-sectionally and longitudinally.

Brief summary: A prospective longitudinal surveillance for a period of 2 months. Sample - identify suitable Chronic Kidney Disease (CKD) patients who undergo HD with functioning AVF. Participants at various age range and both sexes are recruited to observe their access flow, access recirculation and cardiac function and assess their relationship.

Detailed description: All patients recruited who met the inclusion criteria were investigated access flow, access recirculation and cardiac function(including cardiac output,cardiac index,central blood volume,et al).Measurement time is the beginning of HD session (first 30min to 1 hr),Middle of HD session (optional),and the end of the HD session (1hr to 30 min prior to end of session). The follow-up duration is 6 months and 12 months.Repeat the assessment at the above time points.

Eligibility criteria: Inclusion Criteria:

* Patients undergo HD with native AVF
* AF of AVF between 300ml/min and 1800ml/min

Exclusion Criteria:

* Patients whose AVF developed Access Recirculation (AR) which cannot be resolved at the time of measurement
* Patients developed access or systemic infection during the study period

Primary outcomes:
measure: to access the chang of the fistula blood flow in HD patients using Ultrasound Dilution method
timeFrame: Change of the fistula blood flow from baseline to 6 months
Secondary outcomes:
measure: Changes of the Cardiac Index (CI) during the course of hemodialysis therapy
timeFrame: from baseline to 6 months
measure: Changes of the Oxygen delivery ( Adequacy of hemoglobin level to Epoetin) during the course of hemodialysis therapy
timeFrame: from baseline to 6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The 1st Affiliated Hospital, Sun Yet-sen University
state: Guangdong
Study officials:
affiliation: Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
name: Xueqing Yu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00458666: Coagulation Parameters During Pregnancy in Amniotic Fluid
Official title: Coagulation Parameters During Pregnancy in Amniotic Fluid
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Keywords: Amniotic fluid
D-dimer
coagulation
factor X activation
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2007-04-11
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: Amniotic fluid embolism is a rare devastating thromboembolic event, which is probably caused by the entrance of amniotic fluid (AF) to the maternal circulation. While AF contains coagulation activators, their role during pregnancy has not been elucidated. The current study aimed to evaluate coagulation parameters in AF during human pregnancy.

Detailed description: Amniotic fluid embolism is a rare devastating thromboembolic event, which is probably caused by the entrance of amniotic fluid (AF) to the maternal circulation. While AF contains coagulation activators, their role during pregnancy has not been elucidated. The current study aimed to evaluate coagulation parameters in AF during human pregnancy.

Eligibility criteria: Inclusion Criteria:

* Women undergoing amniocentesis during 15-35 weeks of gestation.

Exclusion Criteria:

* A history of venous thromboembolism
* Systemic disease i.e.; diabetes, hypertension, hypo or hyper-thyroidism,
* Anticoagulant treatment
* Abnormal embryo

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Dept of Obstetrics and Gynecology, Rambam-Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Benjamin Brenner, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: Arie Drugan, M.D
role: STUDY_CHAIR
References: