louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00309673: Local Anesthesia and Tuberculin Skin Test in Infants and Children
Official title: Local Anesthesia Effect on Tuberculin Skin Test Results in Infants and Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tuberculosis
Keywords: tuberculosis, tuberculin, childhood, pain
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2006-04-03
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The use of local anaesthesia efficiently reduces pain due to needle puncture. However, when tuberculin skin test is performed it is the skin reaction to tuberculin injection that is studied. It is a quantitative skin reaction measured in millimiters. From the study of literature it is not known whether local anaesthetic modify skin reaction to tuberculin. Therefore, before recommending the use local anaesthesia for tuberculin intradermal injection we have to rule out a potential effect of local anaesthetic on the result of the test. This is particularly important in children, since there are more sensitive to pain than adults


Eligibility criteria: Inclusion Criteria:

hospitalized or non hospitalized infant or child (3 months-15 years)requiring a tuberculin skin test, in our hospital. hospitalized 1 to 3 months old infants requiring a tuberculin skin test, in our hospital.

-

Exclusion Criteria:

* child with contra indication to the use of Lidocaine / prilocaine
* child with evolutive dermatitis on forearms
* premature or newborn (less than 1 month of age)
* infants (1 - 24 months of age)who has yet received repeated local anaesthesia (at least 2)during the 24 previous hours
* infants (1 - 24 months of age)who is treated with a drug that could enhance the risk of methhaemoglobinemia
* child with previous evere local reaction to tuberculin injection (necrosis,ulceration)
* child with history of tuberculosis disease
* child with hepatic failure
* parents or the child himself if lod enough, have not given their agreement for the study

Primary outcomes:
measure: Measurement of tuberculin skin tests reaction performed with and without
measure: local anaesthesia, in a child (intra subject reproducibility)
Secondary outcomes:
measure: influence of local anaesthesia use, on tuberculin skin test interpretation
measure: between observer reproducibility
measure: pain evaluation in child over 5 years of age between tuberculin skin tests performed with and without local anaesthesia
measure: relationship between local anaesthesia use and failure to perform a correct intradermal injection
measure: local tolerance to lidocaine / prilocaine
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debré Hospital
Study officials:
affiliation: APHP
name: Nicole Beydon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02310373: Effects of Nicotine-Free Hookah Smoking on Blood Flow to the Heart, Muscle and Skin
Official title: Effects of Nicotine-Free Hookah Smoking on Blood Flow to the Heart, Muscle and Skin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Nicotine-free Hookah Smoking
Keywords: Nicotine-free hookah
Waterpipe
Smoking
Sympathetic
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a pilot study on the acute effects of nicotine-free hookah (herbal/steam stones) smoking on the sympathetic neural control of the human cardiovascular system. Hookah smoking is known to transiently increase blood pressure and heart rate while decreasing heart rate variability suggesting - but not proving - sympathetic mediation. The contribution of nicotine to these effects is unknown. Here the investigators will directly measure the acute effects of nicotine-free Hookah smoking on sympathetic nerve activity with microneurography (intraneural microelectrodes) and quantify associated regional changes in vasomotor tone.


Eligibility criteria: Inclusion Criteria:

* 18 to 39 years of age
* Habitual Hookah smoker defined as having smoked Hookah \>=12 times in the past 12 months
* Have not smoked cigarettes within the past 12 months

Exclusion Criteria:

* Exhaled carbon monoxide level greater than 10 ppm\* as evidence of current or recent cigarette (excluded if smoked cigarette within 12 months) or Hookah smoking (excluded if smoked Hookah within past 72 hours)
* History of cardiopulmonary disease
* Use of any prescription medication with exception of oral contraceptive pills
* History of psychiatric illness
* History of neurologic disease
* BMI ≥ 35
* Evidence of any of the above by physical examination, ECG or echocardiogram
* Smoked cigarette in the past 12 months
* History of illicit drug use
* Pregnant
* Any other condition(s) deemed by the physician investigators that put subjects at risk for participating in the study

Primary outcomes:
measure: Change in sympathetic nerve activity
timeFrame: Change from baseline in sympathetic nerve activity at 1 hr
Secondary outcomes:
measure: Change in regional myocardial perfusion
timeFrame: Change from baseline in regional myocardial perfusion at 1 hr
Other outcomes:
measure: Change in leg blood flow
timeFrame: Change from baseline in leg blood flow at 1 hr
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Ronald G Victor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00855673: Intermittent Mechanical Compression For Peripheral Arterial Disease
Official title: Intermittent Mechanical Compression For Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Keywords: Claudication
Peripheral Arterial Disease
Intermittent Compression
Mechanical Compression
Flowmedic
Lead sponsor: Hospital Universitario Getafe
Sponsor class: OTHER
First posted: 2009-03-04
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study tests the use of a portable mechanical compression device (FM220, Flowmedic, USA) for the treatment of claudication and peripheral arterial disease.

Major endpoints are improved exercise tolerance and relevant blood pressure ratios


Eligibility criteria: Inclusion Criteria:

* stable claudication with an absolute claudication distance \>40 meters but \<300
* resting ABI in the affected limb \<0.8

Exclusion Criteria:

* presence of diabetes

Primary outcomes:
measure: exercise tolerance
timeFrame: 3 months
Secondary outcomes:
measure: ankle-brachial index
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitario Getafe
name: Joaquin DeHaro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00117273: A Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Oral Contraceptive Regimens
Official title: A Prospective, Single-Center, Open-Label, Randomized Study to Evaluate Suppression of the Pituitary-Ovarian Axis With Three Different Regimens of Oral Contraceptive Pills
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-07-06
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, open-label study to evaluate pituitary ovarian suppression in healthy, reproductive-aged women using three different regimens of oral contraceptives (OCs). Two extended regimen OCs, Seasonale (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of placebo), and Seasonique (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 84 days followed by 7 days of ethinyl estradiol 0.01 mg), and a 28-day regimen OC, Portia (levonorgestrel/ethinyl estradiol 0.15/0.03 mg for 21 days followed by 7 days of placebo).


Eligibility criteria: Inclusion Criteria:

* Premenopausal
* Not pregnant or breastfeeding
* Weight \<200 lbs
* Currently taking oral contraceptives in the standard 28-day regimen for at least two months

Exclusion Criteria:

* Any contraindication to the use of oral contraceptives
* Pregnancy within the last 3 months
* Smoking \> 10 cigarettes per day

Primary outcomes:
measure: Compare differences in hormone patterns (follicle stimulating hormone [FSH], luteinizing hormone [LH], inhibin-B, and estradiol)
timeFrame: Before, during and after the 7-day hormone free interval or EE-supplemented interval
Secondary outcomes:
measure: Compare the differences in hormone withdrawal symptoms
timeFrame: Before, during and after the 7-day hormone free interval or EE-supplemented interval
measure: Compare differences in ovarian follicular development
timeFrame: Before, during and after the 7-day hormone free interval or EE-supplemented intervals
Other outcomes:
Locations:
city: Temple
country: United States
facility: Duramed Investigational Site
state: Texas
Study officials:
affiliation: Duramed Research, Inc.
name: Duramed Protocol Chair
role: STUDY_CHAIR
References:
Clinical trial NCT02740673: Testing Cognitive Functions in Patients With COPD Using a Driving Simulator
Official title: Testing Cognitive Functions in Patients With COPD Using a Driving Simulator
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Little is known about the causes and degree of cognitive dysfunction in patients with Chronic Obstructive Pulmonary Disease (COPD), especially their driving abilities. The purpose of the study is to examine the cognitive skills of patients with COPD by using a driving simulator and to examine correlations to factors that may predict cognitive dysfunction in these patients.


Eligibility criteria: Inclusion Criteria:

* a diagnosis of COPD (Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) \< 0,70)
* no exacerbations within the last 6 weeks
* valid driver's license and having driven a car within the last 3 months

Exclusion Criteria:

* lacking the ability to use the driving simulator
* no valid driver's license
* alcohol abuse (\> 21 units per week)
* a known diagnosis of obstructive sleep apnea
* uncorrected impaired vision or hearing
* unstable ischemic heart disease, left-sided heart failure, severe neurologic diseases, cancer, severe peripheral vascular disease, severe psychiatric diseases, former apoplexia and uncontrolled hypertension, thyroid diseases or diabetes

Primary outcomes:
measure: Standard deviation from the centre of the road
timeFrame: During the 30 min. of driving in the simulator
measure: Number of nil responses
timeFrame: During the 30 min. of driving in the simulator
measure: Response time
timeFrame: During the 30 min. of driving in the simulator
measure: Number of off-road events per hour
timeFrame: During the 30 min. of driving in the simulator
Secondary outcomes:
measure: Number of patients with comorbidities
timeFrame: At enrolment
measure: Lung function tests
timeFrame: At enrolment
measure: Depression and anxiety
timeFrame: At enrolment
measure: Cognitive functions
timeFrame: At enrolment
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Thomas S Prior, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04335773: COVID-19 in Hospitalised Norwegian Children - Risk Factors, Outcomes and Immunology
Official title: COVID-19 in Hospitalised Norwegian Children - Risk Factors, Outcomes and Immunology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric Respiratory Diseases
COVID
Fatigue Post Viral
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Helse Stavanger HF
name: Haukeland University Hospital
name: University Hospital of North Norway
name: Alesund Hospital
name: Norwegian Institute of Public Health
name: The University of New South Wales
name: University of Bristol
name: Sykehuset Ostfold
name: Nordlandssykehuset HF
name: Vestre Viken Hospital Trust
name: Helse Fonna
name: Helse Nord-Trøndelag HF
name: Oslo University Hospital
name: Sykehuset Innlandet HF
First posted: 2020-04-06
Enrollment: 350
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children seeking hospital care i Norway

Brief summary: Prospective cohort study of COVID-19 infection among children in Norway.

Detailed description: This nation-wide, prospective cohort study of COVID-19 infection addresses three main issues: 1) Epidemiological risk factors; 2) Natural history (including immunological mechanisms and long term effects) and 3) Support of infection prevention. Also, the study focuses solely on children.

Children (0-18 years of age) admitted to hospital with suspected COVID-19 are eligible (Fig. 1). Those with confirmed COVID-19 serve as cases, whereas those with non-COVID-19 serve as controls; both groups will be followed prospectively for 6 months. Three objectives/Work Packages (WPs) are defined:

* In WP1, the investigators will investigate risk factors for severe outcome of the acute infection; potential risk factors include sex, age, comorbidities, initial clinical findings, infectious load, and genetic markers.
* In WP2, the investigators will investigate the immunological response to acute infection, focusing on initial innate host response and its associations to inflammatory enhancement, genetic factors and clinical course.
* In WP3, the investigators will investigate the prevalence and risk factors of long-lasting complication, in particular the development of post-infectious chronic fatigue

Eligibility criteria: Inclusion Criteria:

Suspected covid-19 infection and age 0-18 years

Exclusion Criteria:

Age \>18 years

Primary outcomes:
measure: Risk Factors for severe infection
timeFrame: 2030
measure: Immunulogical mechanisms
timeFrame: 2030
measure: Long term outcome
timeFrame: 2030
Secondary outcomes:
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus universistetssykehus
Study officials:
References:
Clinical trial NCT05781373: Effect of Intraoperative PEEP Individualization According to Driving Pressure in Major Abdominal Surgery
Official title: Effect of Intraoperative PEEP Individualization According to Driving Pressure in Major Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mechanical Ventilation Complication
Lead sponsor: Mongi Slim Hospital
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this prospective, randomized trial, including patients scheduled for a major open or laparoscopic abdominal surgery (duration \>2 hours) under general anesthesia , the investigators will compare 2 strategies of protective mechanical ventilation: a fixed intraoperative PEEP of 6 cmH2O and an individualized intraoperative PEEP according to the driving pressure.

Detailed description: Patients will be randomized into 2 groups:

* Fixed PEEP group: will receive protective intraoperative mechanical ventilation: tidal volume: 6 ml/kg of PBW, recruitment maneuvers every immediately after tracheal intubation and every 2 hours and a fixed PEEP of 6 cmH2O
* Individualized PEEP: protective mechanical ventilation with the same modality with an individualization of PEEP levels hourly in order to achieve the lowest driving pressure. PEEP levels will be adjusted after intubation and hourly by increasing or decreasing PEEP levels every 10 respiratory cycles.

The primary outcome: incidence of post operative pulmonary complications during the first post operative days.

Eligibility criteria: Inclusion Criteria:

* BMI\<35, ARISCAT score \> 26, patients scheduled for major abdominal surgery

Exclusion Criteria:

* unplanned post operative ICU stay and mechanical ventilation

Primary outcomes:
measure: incidence of pulmonary post operative complications
timeFrame: first 7 post operative days
Secondary outcomes:
measure: lung aeration score (LAS)
timeFrame: day 1, day 3 and day 7 after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04922073: Practical Usability of EGFR Mutation Detection in ctDNA From Resectable NSCLC
Official title: Practical Usability of EGFR Mutation Detection in ctDNA From Resectable NSCLC
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Neoplasms
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: GENECAST Co., Ltd.
First posted: 2021-06-10
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with clinical stage IB to IIIA Non-small Cell Lung Cancer

Brief summary: The aim of the study is to assess the practical usability of EGFR mutation detection in ctDNA from early NSCLC.


Eligibility criteria: Inclusion Criteria:

* Patient with clinical stage IB to IIIA Non-small Cell Lung Cancer
* Patients with resectable lung cancer
* One of followings: 1) Never-smokers or ex-smokers who quit 10 years ago, 2) Female 3) Subsolid nodule in chest CT 4) Biopsy-proven adenocarcinoma

Exclusion Criteria:

* Patients with metastatic lung cancer (Stage IIIB-IV)
* Patients who underwent chemotherapy or radiotherapy
* Patients with other malignancies

Primary outcomes:
measure: Performance of the EGFR assay
timeFrame: Immediately before the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT00600873: R(+)PPX High Dose Treatment of ALS
Official title: Pharmacokinetics and Nitrative-Oxidative Stress Pharmacodynamics in Amyotrophic Lateral Sclerosis Subjects Taking Daily High-Dose R(+) Pramipexole Dihydrochloride for Six Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Keywords: neuroprotection
oxidative stress
Lead sponsor: Bennett, James P., Jr., M.D., Ph.D.
Sponsor class: INDIV
First posted: 2008-01-25
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: R(+)pramipexole is administered in escalating doses to patients with early ALS. Plasma and spinal fluid levels of R(+)PPX are monitored, in addition to biochemical markers of oxidative stress.


Eligibility criteria: Inclusion Criteria:

* definite ALS no prior exposure to R(+)PPX

Exclusion Criteria:

* ALSFRS at baseline \<40 FVC at baseline \<70%

Primary outcomes:
measure: decline in ALSFRS score
timeFrame: 6 months
Secondary outcomes:
measure: plasma PPX levels
timeFrame: 6 months
measure: CSF PPX levels
timeFrame: 6 months
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Ted M Burns, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang H, Larriviere KS, Keller KE, Ware KA, Burns TM, Conaway MA, Lacomis D, Pattee GL, Phillips LH 2nd, Solenski NJ, Zivkovic SA, Bennett JP Jr. R+ pramipexole as a mitochondrially focused neuroprotectant: initial early phase studies in ALS. Amyotroph Lateral Scler. 2008 Feb;9(1):50-8. doi: 10.1080/17482960701791234.
Clinical trial NCT02089373: A Pilot Study on Usefulness of Probe-based Confocal Laser Endomicroscopy Targeted Gastric Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to conduct a study on genetic pathology, obtaining of pure cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for diagnosing gastric cancer, percentage of cancer cells in biopsy samples is usually 30% or less. Recently, confocal laser endomicroscopy has been introduced for real-time histopathologic diagnosis in various cancers. The investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy will increase the percentage of cancer cells in biopsy samples.


Eligibility criteria: Inclusion Criteria:

1. Age, between 20 and 80
2. Initial-onset gastric cancer which would be treated with surgery

Exclusion Criteria:

1. Previous subtotal gastrectomy
2. Pregnancy or breast milk feeding
3. Active infection
4. Significant cardiopulmonary disease
5. Active hepatitis or severe hepatic dysfunction
6. Severe renal dysfunction
7. Severe bone marrow dysfunction
8. Severe neurologic or psychotic disorder

Primary outcomes:
measure: The percentage of cancer cells in biopsy samples
timeFrame: After 3 days from the end of the endoscopic submucosal dissection
Secondary outcomes:
Other outcomes:
Locations:
city: Seodaemun-gu
country: Korea, Republic of
facility: Institutional Review Board in Severance Hospital
state: Seoul
Study officials:
References: