louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02695446: Administration of Oral Extended Release Minocycline for Assessment of Skin and Plasma Concentrations of Minocycline
Official title: Administration of Oral Extended Release Minocycline for Assessment of Skin and Plasma Concentrations of Minocycline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne
Lead sponsor: BioPharmX, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-01
Enrollment: 12
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the skin and plasma concentrations of minocycline in subjects undergoing treatment of acne vulgaris with oral extended release minocycline. Acne lesion counts and safety/tolerance of the treatment will also be evaluated.

Detailed description: This will be an open label, non randomized, interventional pilot study evaluating the plasma and skin levels of minocycline in 10 subjects with moderate to severe acne vulgaris. Subjects with non inflammatory acne of nodular acne will not be enrolled. Subjects will be on an oral extended release minocycline regimen of up to 2mg/kg once a day for 4 weeks.

Steady state levels of minocycline in plasma and skin will be determined.

Eligibility criteria: Inclusion Criteria:

* Otherwise healthy male and female subjects 14 to 40 years of age
* Moderate to severe inflammatory facial acne vulgaris (EGSA score of 3-5)
* Subjects not using oral or topical antibiotic products for at least 30 days prior to study entry and willing to refrain from use of oral and topical antibiotics for the duration of study participation
* Subjects not currently using and willing to refrain from use of other topical acne products for the duration of study participation

Exclusion Criteria:

* Mild, non-inflammatory or nodular acne vulgaris
* Have current or previous skin cancer
* Have a history of skin disease or presence of skin condition the PI believes would interfere with the study
* Females who report that they are pregnant, planning a pregnancy during the study period or breastfeeding
* Have conditions or factors that the PI believes may affect the response of the skin or the interpretation of the results
* Participation in any clinical study within the previous 30 days or plan concurrent participation in other studies

Primary outcomes:
measure: Plasma Minocycline Level
timeFrame: Assessed at week 2 and week 4; reported at week 4
Secondary outcomes:
measure: Skin/Dermal Levels of Minocycline
timeFrame: Measured at 2 weeks in half the subjects, 4 week biopsies not performed per early stopping rules
Other outcomes:
Locations:
city: Broomall
country: United States
facility: KGL Skin Study Center
state: Pennsylvania
Study officials:
affiliation: KGL, Inc.
name: Stuart Lessin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02942446: Investigative Headgear With Nasal Pillows Continuous Positive Airway Pressure (CPAP) Mask
Official title: Investigative Headgear With Nasal Pillows CPAP Mask
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2016-10-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.

Detailed description: 20 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level Positive airway pressure (PAP) for the treatment of their Obstructive Sleep Apnea (OSA). These include current CPAP mask users.

Eligibility criteria: Inclusion Criteria:

* AHI≥5 from the diagnostic night
* ≥18 years of age
* Prescribed CPAP or Bi-level therapy for OSA
* Existing F\&P Pilairo Q, Eson, Simplus mask users

Exclusion Criteria:

* Inability to give informed consent
* Patient intolerant to CPAP
* Anatomical or physiological conditions making CPAP therapy inappropriate
* History of respiratory disease or carbon dioxide (CO2) retention
* Pregnant or think they may be pregnant
* Investigated by Land Transport Safety Authority

Primary outcomes:
measure: Reliability of the headgear using a Questionnaire
timeFrame: Monthly over a period of 6 months
measure: Durability of the headgear by testing
timeFrame: Monthly over a period of 6 months
Secondary outcomes:
measure: Performance in regards to leak of the headgear
timeFrame: Monthly over a period of 6 months
measure: Performance in regards to comfort of the headgear
timeFrame: Monthly over a period of 6 months
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Fisher & Paykel Healthcare
Study officials:
affiliation: Clinical Research Associate
name: Sarah Gunson, BSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05461846: Effect of Integrated Neuromuscular Inhibition Technique in Females With Menstrual Low Back Pain
Official title: Effect of Integrated Neuromuscular Inhibition Technique on Pain, Function and Muscle Activity in Females With Menstrual Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysmenorrhea
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 30
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dysmenorrhea is a common problem in women of reproductive age. Primary dysmenorrhea is defined as recurrent, cramping pain occurring with menses in the absence of identifiable pelvic pathology .

Detailed description: Primary dysmenorrhea is characterized by a crampy supra-pubic pain that begins somewhere between several hours before and a few hours after the onset of the menstrual bleeding. Symptoms peak with maximum blood flow and usually last less than one day, but the pain may persist up to 2 to 3 days. Symptoms are more or less reproducible from one menstrual period to the other. The pain is characteristically colicky and located in the midline of the lower abdomen and may extend to lower quadrants, the lumbar area, and the thighs.

Menstrual low back pain (LBP) is one of the common complaints among women. Previous studies have indicated that more than 40% to 50% of the population experience LBP during the menstrual phase (days 1-6) of the menstrual cycle .

Eligibility criteria: Inclusion Criteria:

1. Thirty adolescent females suffering from menstrual low back pain.
2. Their age will be ranged from 17 to 24 years.
3. Their body mass index will be ranged from 20 to 25 kg/m2.

Exclusion Criteria:

1. Personal and individual differences between the subjects.
2. Psychological and physical status of subjects which may affect the treatment and evaluation stage.
3. Environmental factors which may affect the subject's response

Primary outcomes:
measure: Pain intensity
timeFrame: up to 2 months
Secondary outcomes:
measure: function
timeFrame: up to 2 months
measure: muscle amplitude in the form of normalized root mean square (RMS)
timeFrame: up to 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00779246: Cost-Effectiveness Study Comparing Chlorhexidine Bathing With Active Surveillance Cultures to Prevent Methicillin-resistant Staphylococcus Aureus & Other Hospital Infections
Official title: Cost-Effectiveness of Chlorhexidine Bathing vs. Active Surveillance Cultures to Prevent Acquisition of Methicillin-resistant Staphylococcus Aureus and Other Hospital-Acquired Infections: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Staphylococcal Infections
Keywords: Methicillin resistance
Infection control
Staphylococcus aureus
Cross infection
Epidemiology
Chlorhexidine
Lead sponsor: Christiana Care Health Services
Sponsor class: OTHER
Collaborators: name: Sage Products, Inc.
First posted: 2008-10-24
Enrollment: 1518
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This pilot study in our medical intensive care unit will evaluate the clinical and cost-effectiveness of an active surveillance program for methicillin-resistant Staphylococcus aureus (MRSA), compared to routine daily bathing with chlorhexidine gluconate (CHG)-impregnated cloths. Outcomes include rate of MRSA acquisition, and of other hospital-acquired infections (e.g., catheter-associated bloodstream infections).


Eligibility criteria: Inclusion Criteria:

* All patients admitted to the medical intensive care unit (ICU) are eligible for inclusion

Exclusion Criteria:

* Patient refusal
* Contraindication to nasal swabbing (arm 1)
* Allergy/sensitivity to chlorhexidine gluconate (CHG) (arm 2)

Primary outcomes:
measure: Acquisition of Methicillin-resistant Staph Aureus (MRSA) Colonization or Infection
timeFrame: During ICU stay
Secondary outcomes:
measure: Number of Participants With Central Line Associated Bloodstream Infection
timeFrame: During ICU stay up to six months
measure: Vancomycin Resistant Enterococcal Infection or Colonization
timeFrame: During ICU stay
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Hospital
state: Delaware
Study officials:
affiliation: Christiana Care Health Services
name: Marci Drees, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01872546: Skin Transcriptional Profiles In Psoriatic Patients Under Adalimumab Biotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Plaque Psoriasis
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT

Brief summary: The expertise in the characterization of transcriptomics profile in lesional psoriatic skin and on the availability of innovative therapy for these patients.The investigators propose to follow the modification of the skin transcriptomics profile in psoriatic patients during successful Adalimumab biotherapy. Skin transcriptomics profiles of normal skin, psoriatic non lesional skin, and psoriatic lesional skin before and after biotherapy will be compared. The investigators will focus on the modification of the cytokine "signature" in these skin lesions and of some markers of keratinocyte inflammation. The modification of the transcriptomics profile induced by the biotherapy will be correlated to the clinical response Psoriasis Area and Severity Index.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic plaque psoriasis involving at least 10% of body surface area with no previous biotherapy.
* Adalimumab prescribed in usual practice

Exclusion Criteria:

* Patients presenting a contraindication to the use of Adalimumab:

hypersensibility in Adalimumab or in one of the excipients.

* Patients presenting an evolutionary tuberculosis or the other severe infections such as sepsis and opportunist infections
* presenting patients one cardiac insufficiencies moderated in severe
* Patients under anakinra or abatacept
* current participation in another study of clinical research

Primary outcomes:
measure: Analyze modifications of the skin inflammatory
timeFrame: 1 month
Secondary outcomes:
measure: skin transcriptomic profile
timeFrame: 1 month
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Chu Poitiers
Study officials:
References:
Clinical trial NCT01638455: Pulse CO-Oximetry Noninvasive Monitoring and Laboratory Measurements of Subject Blood Samples
Official title: Noninvasive Parameter Testing With Pulse CO-Oximetry and Measurement of Blood Constituents With In-Vitro Analyzers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Various Comorbidities
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2012-07-11
Enrollment: 2776
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Characterize Masimo noninvasive technology in spot check reading on subjects and make comparison to invasive blood sampling tested on reference analyzers.

Detailed description: Noninvasive readings from subjects done according to manufacturer's directions of use compared to simultaneously derived blood samples measured on in vitro analyzers

Eligibility criteria: Inclusion Criteria:

* Male or female of any age ≥ 3 kg.
* Subjects may include healthy volunteers, outpatient or inpatient populations

Exclusion Criteria:

* Subjects with skin abnormalities at the planned application sites that may interfere with sensor application or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, etc.
* Subjects deemed not suitable for study at the discretion of the investigator

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo
state: California
Study officials:
References:
Clinical trial NCT05664555: Dose Optimization for Safe and Efficient Fluorescein Angiography (DOSE Study)
Official title: Low Dose Fluorescein Angiography Comparing 1mL and 3mL of 10% Fluorescein: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Retinal Disease
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 144
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to compare the efficacy and safety of fluorescein angiography using 1mL versus 3mL of 10% fluorescein dye.

Detailed description: The investigators will recruit patients who need fluorescein angiography for their retinal diseases.

The investigators will collect data on image quality and complications.

Eligibility criteria: Inclusion Criteria:

* Patients who required an fluorescein angiography for their retinal diseases (eg. diabetic retinopathy, retinal vein occlusion, etc.)

Exclusion Criteria:

* media opacity (corneal opacity, vitreous hemorrhage grade 2 or more, cataract LOCS III grade 3 or more)
* known history of adverse reactions to fluorescein
* dilated pupil diameter less than 5 mm

Primary outcomes:
measure: Subjective image quality from 3 experts
timeFrame: One month
Secondary outcomes:
measure: Objective vessel intensity
timeFrame: One month
measure: Complication
timeFrame: immediately after the test
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
citation: Moosbrugger KA, Sheidow TG. Evaluation of the side effects and image quality during fluorescein angiography comparing 2 mL and 5 mL sodium fluorescein. Can J Ophthalmol. 2008 Oct;43(5):571-5. doi: 10.3129/i08-122.
citation: Friberg TR, Gupta A, Yu J, Huang L, Suner I, Puliafito CA, Schwartz SD. Ultrawide angle fluorescein angiographic imaging: a comparison to conventional digital acquisition systems. Ophthalmic Surg Lasers Imaging. 2008 Jul-Aug;39(4):304-11. doi: 10.3928/15428877-20080701-06.
citation: Nasrallah FP, Jalkh AE, Trempe CL, McMeel JW. Low-dose fluorescein angiography. Am J Ophthalmol. 1988 Jun 15;105(6):690. doi: 10.1016/0002-9394(88)90071-2. No abstract available.
Clinical trial NCT01581255: The Effect of High Frequency Oscillation on Biological Markers of Lung Injury
Official title: The Effect of High Frequency Oscillation on Biological Markers of Lung Injury
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Respiratory Distress Syndrome
Keywords: acute respiratory distress syndrome
high frequency oscillation ventilation
ventilator-induced lung injury
biomarkers
Lead sponsor: Canadian Critical Care Trials Group
Sponsor class: OTHER
Collaborators: name: Canadian Intensive Care Foundation
First posted: 2012-04-20
Enrollment: 2
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically-ill patients with the acute respiratory distress syndrome enrolled in the OSCILLATE trial (NCT01506401).

Brief summary: Mechanical ventilation, although life-saving, damages the lungs through what is known as ventilator-induced lung injury. High frequency oscillation ventilation has been proposed as a ventilation method that may be less injurious to the lungs than conventional mechanical ventilation and may lead to better patient outcomes. To evaluate this hypothesis, the OSCILLATE trial is comparing outcomes in patients with the acute respiratory distress syndrome randomized to high frequency oscillation ventilation vs conventional lung protective ventilation. The present study is a substudy of the OSCILLATE trial looking at biomarkers of ventilator-induced lung injury in blood samples drawn from patients enrolled in OSCILLATE. The objective is to look for biochemical evidence of decreased ventilator-induced lung injury in patients treated with high frequency oscillation ventilation relative to conventional ventilation.


Eligibility criteria: Inclusion Criteria:

* enrollment in OSCILLATE (NCT01506401)

Exclusion Criteria:

* inability to provide blood samples

Primary outcomes:
measure: Change from baseline in biomarkers of ventilator-induced lung injury
timeFrame: 24 hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University of Toronto
name: Alexandra Binnie, MD, DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Claudia dos Santos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Niall Ferguson, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02310555: Surgical Techniques in Diabetes Mellitus-II and Obesity. Metabolic Surgery Study (MSS)
Official title: Prospective Randomised Study Comparing Surgical Techniques in Patients With Diabetes Mellitus-II And Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Obesity
Keywords: Metabolic surgery
Lead sponsor: Hospital Universitario Virgen de la Arrixaca
Sponsor class: OTHER
First posted: 2014-12-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare clinical and laboratory findings of three surgical techniques in metabolic surgery in patients with type II diabetes mellitus and obesity (BMI\> 30).


Eligibility criteria: Inclusion Criteria:

* BMI 30-40
* Diabetes Mellitus type II less than 10 years of evolution.
* Anti-GAD, anti-pancreatic islets negative antibodies.
* C peptide normally between 0.9 and 4.
* Glycosylated hemoglobin greater than 6.5%.
* Less than 5 years of use insulin.

Exclusion Criteria:

* Cirrosis hepática.
* coagulopathies.
* Type 1 diabetes.
* HIV positive.
* Stomach or small intestine previous surgeries .
* Diseases of the exocrine pancreas: pancreatitis, pancreatectomy, neoplasia, cystic fibrosis, hemochromatosis.
* Endocrinopathies: acromegaly, glucagonoma, Cushing's syndrome, pheochromocytoma, hyperthyroidism, somatostatinoma, aldosteronoma.
* Genetic syndromes with diabetes.

Primary outcomes:
measure: Remission diabetes mellitus type II
timeFrame: Durign two years
Secondary outcomes:
measure: Weight loss
timeFrame: During two years
measure: Adverse effects in the short term
timeFrame: During three months since surgery
measure: Adverse effects in the long term
timeFrame: Since third month after surgery untiil two years
Other outcomes:
Locations:
city: El Palmar.
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca
state: Murcia
Study officials:
affiliation: Hospital Clínico Universitario Virgen Arrixaca
name: Juan A. Luján Mompean, Ph D; Section chief
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02786355: Oxygenation Via Frova Bougie and Ambu Bag
Official title: Comparison of Volumes of Air Delivered Through a Frova Intubation Bougie by a Maximal Bimanual Compression Versus a Normal Bimanual Compression of an Adult Ambu® Bag
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Failed or Difficult Intubation
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: We will conduct this study to show that it is possible to deliver air through a Frova bougie and an Ambu® bag.

Detailed description: Participants will be invited to squeeze an Ambu® bag connected to a Frova bougie, and we will measure the volume of air delivered and peak pressure generated.

Eligibility criteria: Inclusion Criteria:

* staff, fellows and resident anesthesiologists

Exclusion Criteria:

* injury to hand

Primary outcomes:
measure: Tidal Volume (ml)
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: BC Women's Hospital,UBC
name: Simon Massey, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dewan P, Taylor J, Gunka V, Albert A, Massey S. Manual volume delivery via Frova Intubating Introducer: a bench research study. Can J Anaesth. 2019 May;66(5):527-531. doi: 10.1007/s12630-019-01308-9. Epub 2019 Feb 12.