louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02427971: A Comparison Between the Aysis® Cs2 (General Electrics) Ventilator in EtControl® Mode and the Perseus® A 500 (Dräger) in VaporView® Mode on Maniability and Consumption of Desflurane
Official title: A Comparison Between the Aysis® Cs2 (General Electrics) Ventilator in EtControl® Mode and the Perseus® A 500 (Dräger) in VaporView® Mode on Maniability and Consumption of Desflurane
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthetics Agent
Consumption
Inhalation
Desflurane
Lead sponsor: Saint Antoine University Hospital
Sponsor class: OTHER
First posted: 2015-04-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ASA 1/2 adult patients undergoing a general anesthesia of more than one hour.

Brief summary: The Aysis® Cs2 ventilator offers an automated control of end-tidal inhalation anesthetic concentration, the EtControl® mode. A low Fresh Gas Flow (FGF) (0.5L/min) is kept during the maintenance of the anesthesia, decreasing the expensive consumption of halogenated agents.

The Perseus® A 500 offers a VaporView® mode that gives the evolution of inspired (Fi) and end-tidal (Fe) fractions of halogenated agents for 20 minutes based on the delivered fraction (Fd). FGF remains adjusted manually by the practitioner. This mode also makes it possible to maintain a low FGF (0.5 L/min), provided the halogen Fd is set to maintain a steady Fe curve.

The goal of this work was to compare the maniability of the intraoperative administered concentrations and the consumption of Desflurane between these 2 modalities of administration.


Eligibility criteria: Inclusion Criteria:

* patients undergoing a general anesthesia for intra abdominal surgery during more than one hour
* ASA 1or 2

Exclusion Criteria:

* contraindication to halogenated agent
* thoracic surgery
* no french speaking

Primary outcomes:
measure: Consumption of Desflurane between these 2 modalities of administration.
timeFrame: Time of general anesthesia (1h minimum up to 12h)
Secondary outcomes:
measure: Comparison of inspired (Fi) and end-tidal (Fe) fractions of halogenated evolution
timeFrame: Time of general anesthesia (1h minimum up to 12h)
measure: Anesthesia depth monitoring by BIS
timeFrame: Time of general anesthesia (1h up to 12h)
measure: Hemodynamic stability
timeFrame: Time of general anesthesia (1h minimum up to 12h)
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint-Antoine
Study officials:
References:
Clinical trial NCT01130571: Establishment and Characterization of Patient-Derived Non-Small Cell Lung Cancer Xenografts and Cell Cultures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Cancer
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2010-05-26
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The investigators for this protocol are clinicians and scientists in the departments of Cardiac/Thoracic and Vascular Surgery, Haematology and Oncology, Pathology, Radiation Oncology, Respiratory Medicine and the Cancer Sciences Institute of Singapore (CSIS) from NUH and NUS with major roles in their departments in the clinical management and/or research of lung cancer. Each will be providing access to clinical information and assisting in the collection and processing of samples, according to their resources and expertise.

Brief summary: Xenografts and cell cultures provide sufficient material for analyses at the protein, RNA and DNA level. Patient derived NSCLC xenografts and cell lines are available but none however are Asian in origin. Given the emerging evidence to suggest inter-ethnic differences in NSCLC biology, new models of preclinical drug evaluation should be designed and validated using Asian tumors. Furthermore, such models will allow studies of biological mechanisms of sensitivity and/or resistance and also the study of dynamic regulations under standardized conditions in the Asian context.


Eligibility criteria: Inclusion Criteria:

* Patients aged 21 years and above.
* Undergoing a surgical resection of tumor as part of clinical management

Exclusion Criteria:

* Patient or legally acceptable representative unable to provide consent patient in the judgement of the study investigator, is medically unsuitable for this study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References:
citation: Parkin DM, Bray F, Ferlay J, Pisani P. Estimating the world cancer burden: Globocan 2000. Int J Cancer. 2001 Oct 15;94(2):153-6. doi: 10.1002/ijc.1440. No abstract available.
citation: Thun MJ, Hannan LM, Adams-Campbell LL, Boffetta P, Buring JE, Feskanich D, Flanders WD, Jee SH, Katanoda K, Kolonel LN, Lee IM, Marugame T, Palmer JR, Riboli E, Sobue T, Avila-Tang E, Wilkens LR, Samet JM. Lung cancer occurrence in never-smokers: an analysis of 13 cohorts and 22 cancer registry studies. PLoS Med. 2008 Sep 30;5(9):e185. doi: 10.1371/journal.pmed.0050185. Epub 2008 Sep 9.
Clinical trial NCT02178371: Constraint Induced Movement Therapy on Infantile Hemiplegia
Official title: Effects of Modified Constraint Induced Movement Therapy on Infantile Hemiplegia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia
Keywords: Upper extremity
Physical therapy modalities
Lead sponsor: CEU San Pablo University
Sponsor class: OTHER
First posted: 2014-06-30
Enrollment: 16
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the functionality of the affected upper limb in infantile hemiplegia by applying a protocol of modified constraint-induced movement therapy.


Eligibility criteria: Inclusion Criteria:

* Children's Hemiplegia Medical diagnosis.
* Aged between 4 and 8 years.
* Lack of activity of the affected upper extremity.
* Overcoming 10th extension at the metacarpophalangeal and interphalangeal joint.
* Complete the 20 º of wrist extension of the affected upper extremity.
* Adequate cognitive development to understand verbal commands given for the execution of tasks.
* Cooperation in the execution of tasks.

Exclusion Criteria:

* To Have vision problems that prevent them from carrying out the intervention.
* Having significant balance changes that endanger the child fall to bring a restriction in the affected upper limb.
* Submit uncontrolled seizures.
* To Have received botulinum toxin prior to 6 months prior to the intervention.

Primary outcomes:
measure: Change from baseline on the Quality of Upper Extremity Skills Test (QUEST) at week 5.
timeFrame: Baseline, week 5.
measure: Change from baseline on the Shuee Evaluation at week 5
timeFrame: baseline, week 5
Secondary outcomes:
measure: Change from baseline on visual-motor coordination at week 5.
timeFrame: Baseline, week 5.
measure: Change from baseline on Grip strength at week 5.
timeFrame: Baseline, week 5.
measure: Change from baseline on the Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) at week 5.
timeFrame: Baseline, week 5.
Other outcomes:
Locations:
city: Boadilla del Monte
country: Spain
facility: San Pablo CEU University
state: Madrid
Study officials:
affiliation: San Pablo CEU University
name: Rocio Palomo Carrión, PhD, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: San Pablo CEU University
name: Francisco García-Muro SAn José, PhD, PT
role: STUDY_DIRECTOR
References:
Clinical trial NCT03280771: The Hope Soap Study: a Hand-washing Intervention Among Children in South Africa
Official title: The Hope Soap Study: a Randomized Controlled Trial of a Hand-washing Intervention Among Children in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand-washing Behavior
Diarrhea
Lead sponsor: University of Cape Town
Sponsor class: OTHER
Collaborators: name: Abdul Latif Jameel Poverty Action Lab
First posted: 2017-09-12
Enrollment: 288
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Hope Soap Study is a randomised-control pilot study of a hand-washing intervention in which children in treatment households received a bi-monthly delivery of HOPE SOAP©, a colourful, translucent bar of soap with a toy embedded in its centre.


Eligibility criteria: Inclusion Criteria:

* Enrolled in the Family-in-Focus program
* Caregiver provided informed consent
* the age-eligible children were not involved in any other sort of ECD program (e.g. crèche or other day-care)

Exclusion Criteria:

* Enrollment in an ECD program

Primary outcomes:
measure: Direct observation of hand washing prior to eating a snack
timeFrame: 8 weeks
Secondary outcomes:
measure: Questionnaire data on hand washing after using the toilet (scale of 1-10)
timeFrame: 8 weeks
measure: Questionnaire data on hand washing prior to meals (scale of 1-10)
timeFrame: 8 weeks
measure: Questionnaire data on general soap usage when washing hands (scale of 1-10)
timeFrame: 8 weeks
measure: Questionnaire data on experience of illness (13 items)
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Burns J, Maughan-Brown B, Mouzinho A. Washing with hope: evidence of improved handwashing among children in South Africa from a pilot study of a novel soap technology. BMC Public Health. 2018 Jun 7;18(1):709. doi: 10.1186/s12889-018-5573-8.
Clinical trial NCT01303471: Pain Assessment During General Anesthesia
Official title: Pain Assessment During General Anesthesia : DOLANS (DOULeur ANeSthesie) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: pain assessment
anesthesia
analgesia
opioid
HRV
APV
autonomic nervous system (ANS)
pupil size
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2011-02-24
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: During general anesthesia, two treatments are used : hypnotic and opioid treatment. Opioid treatment is used for pain assessment.

The change in haemodynamic variables and clinical sign are evaluated during anesthesia for pain assessment but these changes are not specific every time.

The main of this study is to investigate the relationship between calculated compartment concentration of remifentanil (opioid) and the parameters from HRV (Heart Rate Variability) and APV (Arterial Pressure Variability) before a standard noxious stimulation during general anesthesia at calibrated hypnosis level.

Our hypothesis is that nociceptive stimulation would have reproductible effects on HRV, and that these effects would be blunted or abolished by by adequate analgesia. The current study is thus designed to analyse HRV and APV in patients with stable hypnosis, before and during nociceptive surgical stimulation, at different levels of analgesia.


Eligibility criteria: Inclusion Criteria:

* Adult patients under 55 years-old
* ASA status 1 or 2
* scheduled to undergo general anesthesia for different types of surgery (neurosurgical or medullar surgery, ear, nose or throat surgery or orthopedic surgery)

Exclusion Criteria:

* history of cardiac or autonomic disease
* diabetes
* obesity (BMI\>30 kg/m2)
* medication altering autonomic nervous system tone
* history of eyes surgery

Primary outcomes:
measure: Change from baseline in HRV measurements during noxious stimulation
timeFrame: baseline and 5 minutes
measure: change from baseline in APV measurements during noxious stimulation
timeFrame: baseline and 5 minutes
Secondary outcomes:
measure: Change from baseline in pupil change during noxious stimulation
timeFrame: baseline and 5 minutes
measure: change from baseline in heart rate during noxious stimulation
timeFrame: baseline and 5 minutes
measure: Change from baseline in BIS (Bispectral Index) during noxious stimulation
timeFrame: baseline and 5 minutes
measure: change from baseline in systolic blood pressure during noxious baseline
timeFrame: baseline and 5 minutes
measure: Change from baseline in diastolic blood pressure during noxious stimulation
timeFrame: basline and 5 minutes
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: CHU de Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: David Charier
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02981771: The Effect of Exercise Training Programs On Balance in Older Adults With CVD
Official title: The Effect of Exercise Training Programs - Stability and Coordination - On Static Balance, Dynamic Balance and Risk of Falls in Older Adults With Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Cardiovascular Diseases
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-12-05
Enrollment: 31
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Individuals of advanced age with cardiovascular disease are at higher risk of fall.The aim of this study is to explore the effect of specific exercise program based on balance and coordination on stability parameters


Eligibility criteria: Inclusion Criteria:

* Has Cardiovascular disease, under the supervision of a cardiologist
* Participates in a cardiovascular rehabilitation center
* Able to undergo physical activity for 60 minutes twice a week

Exclusion Criteria:

* All Other

Primary outcomes:
measure: Change in Balance ability - a composite outcome
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wingate
country: Israel
facility: Zinman College for Physical Education and Sport Sciences
Study officials:
References:
Clinical trial NCT00834171: A Retrospective Evaluation of the Intraocular Pressure Spikes With Loteprednol and Loteprednol/Tobramycin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-02-03
Enrollment: 50
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: Data to be collected will include: Patient Demographics (age, gender, race, eye color), medical and ophthalmic history, active ophthalmic disease, active systemic diseases, concomitant medications, procedure/condition for which Lotemax®/Zylet® were prescribed, underlying etiology requiring PK (if applicable), history of prior ocular surgery, prior history of steroid response, history of glaucoma, start/stop date of steroid treatment, IOP before and after steroid treatment, treatment-related adverse events, and any other notes/information that the investigator feels may be important.

Brief summary: Patient charts will be reviewed to evaluate the incidence of intraocular pressure spikes while on Loteprednol etabonate ophthalmic suspension 0.5%, Loteprednol etabonate (0.5%) and tobramycin (0.3%)


Eligibility criteria: Inclusion Criteria:

* Any patient who experienced an IOP spike while using Lotemax or Zylet will be included

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Mean Elevated Intraocular Pressure (IOP) During Treatment
timeFrame: 55 days
Secondary outcomes:
Other outcomes:
Locations:
city: Maclean
country: United States
state: Virginia
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00896571: Transdermal Contraceptive Patch - Endometrial Effects Study
Official title: Single-center,Open-label, Uncontrolled Study to Investigate the Effects of the Transdermal Contraceptive Patch Containing 0.55 mg Ethinylestradiol and 2.1 mg Gestodene on the Endometrium in a 21-day Regimen for 13 Cycles in 80 Healthy Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contraception
Keywords: Fertility control
Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-05-11
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of the present study is to investigate the effects of the transdermal patch on the endometrium in healthy women who require contraception.


Eligibility criteria: Inclusion Criteria:

* Requiring contraception
* Normal cervical smear
* Smokers not older than 30 years
* History of regular cyclic menstrual periods

Exclusion Criteria:

* Pregnancy or lactation
* Obesity (BMI\> 30 kg/m2)
* Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
* Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
* Use of other contraceptive methods than study medication

Primary outcomes:
measure: Effect on the endometrium at cycle 13
timeFrame: 13 treatment cycles (each consisting of 28 days)
Secondary outcomes:
measure: Cervical smear
timeFrame: 13 treatment cycles (each consisting of 28 days)
measure: Adverse events
timeFrame: 13 treatment cycles (each consisting of 28 days)
measure: Cycle control
timeFrame: 13 treatment cycles (each consisting of 28 days)
measure: Safety laboratory
timeFrame: 13 treatment cycles (each consisting of 28 days)
measure: Occurence of pregnancy
timeFrame: 13 treatment cycles (each consisting of 28 days)
Other outcomes:
measure: Treatment compliance
timeFrame: 13 treatment cycles (each consisting of 28 days)
measure: Subjective assessment of satisfaction with the treatment
timeFrame: 13 treatment cycles (each consisting of 28 days)
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00715871: Clinical Study of Smoke-Break Liquid Cigarettes
Official title: Phase II Study to Measure Effectiveness and to Monitor Side Effects of Smoke-Break Nicotine Delivery Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking
Keywords: smoking
smoke cessation
stop smoking
quit smoking
nicotine replacement therapy
Smoke Break
liquid cigarette
liquid nicotine cigarette
Lead sponsor: Smoke-Break, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the Smoke-Break nicotine delivery device can help smokers quit smoking, while avoiding many of the side effects associated with other smoking cessation products.

Detailed description: The study has been completed and published. The published study manuscript can be found here: http://www.biomedcentral.com/1471-2458/10/155

Eligibility criteria: Inclusion Criteria:

* Volunteer is at least 18 years of age.
* Volunteer currently smokes cigarettes, cigars or other forms of tobacco products for at least one year.
* Volunteer wants to quit smoking.
* Volunteer will be fully informed as to the nature of the study.
* Volunteer will have no known allergy to any product ingredients as listed in the informed consent.
* Volunteer agrees to a confidential pretest questionnaire and periodic monitoring as to the effectiveness of the smoking cessation regimen.
* Volunteers are not currently using another nicotine replacement therapy.
* Volunteer will agree to use birth control measures while on the study.

Exclusion Criteria:

* Volunteer has a known allergy or hypersensitivity to nicotine or other related ingredients as outlined in the informed consent.
* Volunteer does not desire to quit smoking.
* Volunteer is using another nicotine replacement therapy.
* Volunteer is pregnant or breast-feeding.
* Volunteer has a history of heart disease or advanced diabetes.
* Volunteer indicates on the application that they smoke ten (10) or fewer cigarettes per day.
* Volunteer is using a daily prescription medicine for depression or asthma.
* Volunteer is using a non-nicotine smoke cessation drug, such as Zyban or Chantix.
* Volunteer is an employee of Smoke-Break Inc., or is personally known to an employee of Smoke-Break Inc.

Primary outcomes:
measure: Smoke cessation
timeFrame: 12 weeks
Secondary outcomes:
measure: Side effects
timeFrame: 0-12 weeks
Other outcomes:
Locations:
city: West Allis
country: United States
facility: Tommy G. Thompson Youth Center
state: Wisconsin
Study officials:
affiliation: Smoke-Break, Inc.
name: Nicholas Geimer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Geimer N, Olson CE, Baumgarten D, Kepner JL, Mahoney MC. Use of a liquid nicotine delivery product to promote smoking cessation. BMC Public Health. 2010 Mar 24;10:155. doi: 10.1186/1471-2458-10-155.
Clinical trial NCT04125771: Diclofenac Potassium Alone Versus Diclofenac Potassium With Hyoscine-N-butyl Bromide (HBB in Endoscopy
Official title: Diclofenac Potassium Alone Versus Diclofenac Potassium With Hyoscine-N-butyl Bromide (HBB in Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2019-10-14
Enrollment: 64
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Diclofenac is a proven, commonly prescribed nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic properties, and has been shown to be effective in treating a variety of acute and chronic pain and inflammatory conditions.

Detailed description: Diclofenac is a proven, commonly prescribed nonsteroidal anti-inflammatory drug (NSAID) that has analgesic, anti-inflammatory, and antipyretic properties, and has been shown to be effective in treating a variety of acute and chronic pain and inflammatory conditions.

. As with all NSAIDs, diclofenac exerts its action via inhibition of prostaglandin synthesis by inhibiting cyclooxygenase-1 (COX-1)

Eligibility criteria: Inclusion Criteria:

* 1. Patients indicated for diagnostic hysteroscopy including infertility, bleeding, suspected intrauterine pathologies (eg polypi , septea) 2. Reproductive age 20 - 40yrs

Exclusion Criteria:

* 1. Menopausal and amenorrhic patients 2. Contraindication to office hysteroscopy such as:- pelvic inflammatory disease, marked cervical stenosis, pregnancy

Primary outcomes:
measure: The number of women who will not feel pain
timeFrame: within half an hour
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah and Kasralainy hospital
Study officials:
affiliation: Algezeera hospitaland National Research Centre ,Egypt
name: Mahmoud Alalfy, PhD
role: STUDY_CHAIR
References: