louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03809832: Microbiologic Contamination of Home Non Invasive Ventilators
Official title: Microbiologic Contamination of Home Non Invasive Ventilators
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Respiratory Failure
COPD
Obesity Hypoventilation Syndrome
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: ADIR Association
First posted: 2019-01-18
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients established on long term home non-invasive ventilation admitted for a scheduled review.

Brief summary: Home non-invasive ventilators are daily used by patients with chronic respiratory failure. There are frequently used with warming and humidifying systems. These systems need to be cared for and frequently washed by the patient.

The aim of this study is to evaluate if the humidifying system of home ventilators are colonized by microbiological germs.

Detailed description: The use of non-invasive ventilators is common for treating respiratory failure. Their care relies on the patients and their carers.

No study has assessed the efficacy of such care with respect to the number of microbiological specimens that remain in the humidifier.

Eligibility criteria: Inclusion Criteria:

* Patient established on home non invasive ventilation for more than 6 months
* With a compliance \>4hours/day
* Who brought their ventilator for the assessment
* Diagnosed with COPD or Obesity hypoventilation syndrome (OHS)
* Who consent
* With an age \> 18 years

Exclusion Criteria:

* Age under 18
* Ongoing exacerbation
* Not able to consent
* Pregnant or breastfeeding

Primary outcomes:
measure: Prevalence of microbial contamination of non invasive ventilators humidifier
timeFrame: 7 days
Secondary outcomes:
measure: Microbiological ecology in the study population
timeFrame: 7 days
measure: Comparison between COPD and Obesity hypoventilation syndrome patients microbial ecology
timeFrame: 7 days
measure: Compliance to recommendations regarding the maintenance of the humidifier
timeFrame: 7 days
measure: Correlation between compliance to maintenance recommendations and contamination rate
timeFrame: 7 days
measure: Comparison of exacerbation frequency in COPD patients and isolation of respiratory pathogens in the humidifier
timeFrame: 12 months
Other outcomes:
Locations:
city: Bois-Guillaume
country: France
facility: Rouen University Hospital
state: Normandy
Study officials:
affiliation: University Hospital, Rouen
name: Maxime Patout, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05558137: Mivacurium 0.2 mg/kg in Young (18 - 40 Years) and Elderly (= 80 Years) Patients
Official title: An Observational Study of Mivacurium 0.2 mg/kg, Comparing Onset Time, Duration of Action and Effect on Intubating Conditions in Young (18 - 40 Years) and Elderly (= 80 Years) Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Onset Time of Mivacurium, Duration of Action of Mivacurium
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients (≥ 80 years) and younger patients (18-40 years) scheduled for elective surgery

Brief summary: The aim of this study is to determine the onset time, duration of action and effect on intubation conditions of mivacurium 0.2 mg/kg in elderly patients with age ≥ 80 years and in young patients aged 18 - 40 years.

Detailed description: The aim of this study is to determine the onset time, duration of action and effect on intubation conditions of mivacurium 0.2 mg/kg in elderly patients with age ≥ 80 years and in young patients aged 18 - 40 years. The hypothesis of this study is that mivacurium administered in elderly patients (\>80 years) has a longer onset time and duration of action compared to younger patients.

Eligibility criteria: Inclusion Criteria:

1. Patients ≥ 80 or ≥ 18 to ≤ 40 years of age
2. Informed consent
3. Scheduled for elective surgery under general anaesthesia (expected duration of anaesthesia \> 1 hour) with intubation and use of mivacurium
4. American Society of Anesthesiologists (ASA) physical status classification I to III
5. Can read and understand Danish

Exclusion Criteria:

1. Known allergy to mivacurium
2. Neuromuscular disease that may interfere with neuromuscular monitoring
3. Indication for rapid sequence induction
4. Surgery in the prone position
5. Known butyrylcholinesterase deficiency

Primary outcomes:
measure: Onset time
timeFrame: within 10 minutes after administration of mivacurium
Secondary outcomes:
measure: Duration of action
timeFrame: within 90 minutes after administration of mivacurium
measure: Intubation conditions IDS
timeFrame: within 10 minutes after administration of mivacurium
measure: Intubation conditions Fuchs-Buder
timeFrame: within 10 minutes after administration of mivacurium
measure: Laryngeal morbidity
timeFrame: 24 hours after surgery
measure: Amount of ephedrine or metaoxedrine administered
timeFrame: within 10 minutes after administration of mivacurium
measure: Butyrylcholinesterase activity in a venous blood sample
timeFrame: within 7 days after administration of mivacurium
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet University of Copenhagen
name: Matias Vested
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03738137: Narcotrend Versus Bispectral Index Monitoring During Sufentanil-Midazolam Anesthesia for Bronchoscopy
Official title: Narcotrend Versus Bispectral Index Monitoring During Sufentanil-Midazolam Anesthesia for Bronchoscopy Under Conscious Sedation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchoscopy
Keywords: Narcotrend
Bispectral index
Bronchoscopy
Conscious Sedation
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study was aimed to determine whether narcotrend monitoring was better than bispectral index monitoring during sufentanil-midazolam anesthesia for bronchoscopy under conscious sedation. Patients were randomised to receive Narcotrend, Bispectral Index(BIS) monitoring or without monitoring. Midazolam was given by non-anaesthetist physicians to achieve moderate levels of sedation as assessed by the narcotrend index (NI; B and C) or bispectral index (BIS; between 70 and 85) or according to patient's tolerance assessed by physician . The primary end-point was dosage of midazolam. Other end-points included adverse events, patient tolerance and physician satisfaction.


Eligibility criteria: Inclusion Criteria:

ASA grade I-II

Exclusion Criteria:

1. psychological disorders
2. SpO2\<90% in ambient air
3. hypersensitivity or allergy to anaesthetic drugs or benzodiazepine
4. severe chronic obstructive pulmonary disease (forced expiratory volume in 1 s ,50% of predicted value, requirement for oxygen therapy)
5. unstable haemodynamic status
6. habitual alcohol consumption

Primary outcomes:
measure: Dosage of Midazoam
timeFrame: during the procedure
Secondary outcomes:
measure: patient's subjective tolerance
timeFrame: 30minutes after bronchoscopy
measure: patient's global tolerance assessed by operator
timeFrame: 30minutes after bronchoscopy
measure: adverse events rate
timeFrame: every 3 minutes during the procedure and at 5, 15 and 30 minutes thereafter.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT02141737: Effect of Pre-injection of Lidocaine on Myoclonus Induced by Induction With Etomidate in Elderly Patients During General Anesthesia
Official title: Effect of Pre-injection of Lidocaine on Myoclonus Induced by Induction With Etomidate in Elderly Patients During General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: General Anesthesia
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2014-05-19
Enrollment: 272
Sex: ALL
Minimum age (years): 60
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of pre-injection of lidocaine on myoclonus induced by induction with etomidate during general anesthesia in elderly patients


Eligibility criteria: Inclusion Criteria:

* 1. Aged between 60 and 81 years 2. Body mass index: 20 to 30 kg/m2 3. American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ 4. Signed informed consent form

Exclusion Criteria:

* 1. Use of sedatives or opioids 2. History of central nervous system diseases, like epilepsy, shaking palsy, or chorea, etc 3. Hyperthyroidism 4. Serious diabetes 5. Hyperkalemia 6. Cardiac surgery 7. Serious ventricular disease or atrioventricular block 8. Liver or renal dysfunction 9. Allergies to amide local anesthetics or fat emulsion

Primary outcomes:
measure: severity of myoclonus induced by
timeFrame: 90 seconds from the beginning of etomidate injection
measure: intensity of injection pain
timeFrame: during the injection of etomidate, expected to be within 1 minutes
Secondary outcomes:
measure: hemodynamic parameters after injection of etomidate
timeFrame: baseline to 2 minutes after injetion of etomidate
Other outcomes:
Locations:
city: Xi'an
country: China
facility: TangDu Hospital,FMMU
state: Shanxi
Study officials:
References:
Clinical trial NCT00945737: A Study on the Effects of Soy Protein on Blood Lipids in Men and Women With Mild to Moderate Hypercholesterolemia
Official title: A Randomized, Controlled Parallel Study to Evaluate the Effects of a Non-Commercial Soy Protein Product on Fecal Bile Acids and Blood Lipids in Men and Women With Mild to Moderate Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: hypercholesterolemia
cholesterol
soy
Lead sponsor: Solae, LLC
Sponsor class: INDUSTRY
First posted: 2009-07-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objectives of the trial are to determine whether a non-commercial soy protein product, consumed as part of a low-saturated fat diet, reduces low-density lipoprotein cholesterol (LDL-C) concentrations in men and women with mild to moderate hypercholesterolemia, and affects other aspects related biomarkers.


Eligibility criteria: Inclusion Criteria:

* Male or female
* 18-79 years of age
* Fasting LDL-Cholesterol level borderline to high range taking no cholesterol lowering medications
* otherwise judged to be in good health, willing to maintain a stable body weight and follow the TLC diet throughout the trial.

Exclusion Criteria:

* CHD or CHD risk equivalent
* Pregnancy
* Food allergy or sensitivity to soy or milk protein
* Certain muscle, liver, kidney, lung or gastrointestinal conditions and medications
* Poorly controlled hypertension
* Cancer treated within prior 2 years

Primary outcomes:
measure: The difference between treatment groups in the percent change from baseline to the end of treatment in LDL-C
timeFrame: 4 weeks
Secondary outcomes:
measure: Changes in other lipid levels and other related biomarkers
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Addison
country: United States
facility: Provident Clinical Research
state: Illinois
city: Bloomington
country: United States
facility: Provident Clinical Research
state: Indiana
Study officials:
affiliation: Provident Clinical Research
name: Matthew Reeves, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Provident Clinical Research, Addison, IL
name: Mano Patri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maki KC, Butteiger DN, Rains TM, Lawless A, Reeves MS, Schasteen C, Krul ES. Effects of soy protein on lipoprotein lipids and fecal bile acid excretion in men and women with moderate hypercholesterolemia. J Clin Lipidol. 2010 Nov-Dec;4(6):531-42. doi: 10.1016/j.jacl.2010.09.001. Epub 2010 Oct 1.
Clinical trial NCT03885037: Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Rheumatoid Arthritis)
Official title: Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" General Investigation (Rheumatoid Arthritis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Infliximab
biosimilar
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-03-21
Enrollment: 77
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Rheumatoid Arthritis treated by Infliximab BS

Brief summary: To collect information on the safety and effectiveness of Infliximab BS for Intravenous Drip Infusion 100 mg "Pfizer" against rheumatoid arthritis under actual status of use.


Eligibility criteria: Inclusion Criteria:

* Patients with rheumatoid arthritis who started treatment with this drug
* Patients who received this drug for the first time after the day of launch of this drug.

Primary outcomes:
measure: Incidence of adverse drug reactions
timeFrame: 30 weeks from the day of initial dose
Secondary outcomes:
measure: Disease Activity Score Based on 28-joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP])
timeFrame: Week 30
measure: Percentage of Participants With Remission (DAS28-4[CRP])
timeFrame: Baseline, Week30
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer Local Country Office
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04273737: Amantadine in Treating Cognitive & Motor Impairments in Adolescents and Adults With Cerebral Palsy
Official title: Use of Amantadine in Treating Cognitive and Motor Impairments in Adolescents and Adults With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cerebral Palsy
Keywords: cerebral palsy
amantadine
cognitive function
gross motor skills
fine motor skills
mood
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 11
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Cerebral palsy (CP) is a common childhood-onset disability associated with motor and cognitive impairments, however most research is focused on motor outcomes. The aim of this study is to determine the effects of Amantadine, a dopaminergic agonist, on cognitive function in adolescents and adults with CP.

Detailed description: CP is a heterogeneous condition due to injury to the developing brain. It is a condition that is often marked by both cognitive and motor disorders as well as increased prevalence of depression and anxiety. While most studies have focused on improving motor dysfunction, fewer have investigated cognitive impairments associated with CP. Dedicating a study to research the pharmacotherapeutic effect of Amantadine on cognitive function in adolescents and adults with cerebral palsy fills an important gap in development of a potential innovative treatment for cognitive deficits. The investigators hope to determine the effects of Amantadine on cognitive function in adolescents and adults with CP. The investigators will also evaluate secondary goals of improving gross and fine motor skills and mood.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Cerebral Palsy

Exclusion Criteria:

* Currently pregnant
* Unstable seizure condition
* Currently taking methadone
* Currently taking other dopamine agonists
* Currently taking anti-psychotic medication
* Previously taken amantadine
* Diagnosed with Chronic Kidney Disease (CKD)

Primary outcomes:
measure: Mean Brief-A Score
timeFrame: Baseline
measure: Mean Brief-A Score
timeFrame: 3 weeks
measure: Mean Brief-A Score
timeFrame: 6 weeks
Secondary outcomes:
measure: Mean PHQ-9 Score
timeFrame: Baseline
measure: Mean PHQ-9 Score
timeFrame: 3 weeks
measure: Mean PHQ-9 Score
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia Irving Medical Center
name: Heakyung Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02447237: Randomized Trial:the Effect of Liquid Food on the Intake of Energy and Protein in Malignant Hematologic Patients
Official title: Randomized Controlled Trial About the Effect of Liquid Compared to Solid Food on the Intake of Energy and Protein in Patients With Leukemia, Lymphoma or Other Malignant Hematologic Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematological Disease
Delayed Gastric Emptying
Malignant Disease
Keywords: liquid diet
solid diet
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2015-05-18
Enrollment: 20
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 study investigates the effect of liquid food on the intake of energy and protein compared to solid food. One group will receive dietary counselling in fulfilling their need for energy and protein from liquid food and the other group from solid food.

Detailed description: The study investigates the effect of liquid food on the intake of energy and protein compared to solid food. One group will receive dietary counselling in fulfilling their need for energy and protein from liquid food and the other group from solid food. Both groups need to register their dietary intake in a period of 14 days and will be weighed three times during the intervention. At the end of the intervention they need to fill out a questionnaire.

Eligibility criteria: Inclusion Criteria:

* patients with leukemia, lymphoma or other malignant hematological disease
* adults
* be able to talk and understand danish
* be able to eat both solid and liquid food

Exclusion Criteria:

* not able to cooperate
* need for total tube or parenteral nutrition
* need for dialysis

Primary outcomes:
measure: Intake of energy and protein
timeFrame: 14 days
Secondary outcomes:
measure: Weightloss change in percent from baseline
timeFrame: 14 days
measure: Amount of infections
timeFrame: 14 days
measure: Need for tube feeding and parenteral nutrition
timeFrame: 14 days
measure: patient satisfaction as well as perception of own nutritional status
timeFrame: 14 days
measure: patients compliance of following the nutritional guidelines in the liquid group
timeFrame: 14 days
measure: Dose of cytostatics
timeFrame: 14 days
measure: unplanned hospital stay
timeFrame: 14 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Hematological clinic
Study officials:
affiliation: Rigshospitalet, Denmark
name: Jens R Andersen, Lektor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01197937: Relationship of Realize Mysuccess Usage to Outcomes of Bariatric Surgery
Official title: Relationship of Realize Mysuccess Usage to Outcomes of Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery
Obesity
Weight Loss
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Ethicon Endo-Surgery
First posted: 2010-09-09
Enrollment: 25000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be men and women, 18-65 years old, with a BMI of 40-70 kg/m2 (or 35-70 kg/m2 in the presence of co-morbidities) who have registered in the RMS system and have log into the system at least once postoperatively.

Brief summary: The goal of this observational study is to assess the efficacy of Realize My Success (RMS),a website that allows patients and providers to maintain contact via the website. We will compare RMS users on a number of different variables with the goal of identifying which variables are associated with optimal outcomes (larger weight losses) at one year (and potentially beyond). The study has two primary objectives. The first is to assess changes in body weight at postoperative year 1 in frequent v. infrequent RMS users. We predict that frequent users will achieve significantly greater reductions in weight at 6 and 12 months (and beyond) than infrequent users. The second objective is to assess changes in body weight at postoperative year 1 in persons who use different features of the RMS site. We hypothesize that persons who, on a regular basis, record their food intake, track their physical activity and make specific behavioral goals will experience significantly greater reductions in weight beginning 6 months after surgery as compared to those who do not use these features of the RMS site.


Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* BMI between 40-70 kg/m2 (or 35-70 kg/m2 in the presence of co-morbidities)
* Have registered in the Realize Mysuccess Systema and have logged into the system at least once postoperatively.

Exclusion Criteria:

* We will be receiving/analyzing a data set based on the inclusion criteria, therefore there is no set exclusion criteria for our research.

Primary outcomes:
measure: Assess changes in body weight in frequent v. infrequent RMS users
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: