louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00348335: Efficacy of Topical Cyclosporin for Ocular Rosacea
Official title: Efficacy of Topical Cyclosporin 0.05% for the Treatment of Ocular Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rosacea
Lead sponsor: Ophthalmic Consultants of Long Island
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2006-07-04
Enrollment: 35
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 purpose of this study is to determine whether Restasis (topical cyclosporin) is effective in the treatment of ocular rosacea

Detailed description: The study is designed to compare the efficacy of topical cyclosporin (Restasis) with that of Refresh Endura for the treatment of the signs and symptoms of ocular rosacea in patients presently controlled on topical corticosteroids

Eligibility criteria: Inclusion Criteria:

* Patient at least 18 years old, but younger than 65
* Diagnosis of acne rosacea
* Active ocular rosacea based on lid findings of meibomian gland dysfunction with lid telangiectasia and hyperemia of at least 2+
* Schirmers test of greater than 5mm in at least 1 eye
* If patient currently using lid hygiene must maintain regimen during study
* Stop oral antibiotics at least 4 weeks prior

Exclusion Criteria:

* Use of topical cyclosporin within last 90 days
* Visual acuity of 20/100 or better in both eyes
* Pregnant or lactating females
* Active ocular infection
* Scarring of central cornea
* Eyelid defects,abnormal lid positioning or lagophthalmos
* Flax seed or Fish oil supplements within last 30 days

Primary outcomes:
measure: hyperemia
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: StonyBrook
country: United States
facility: 2500 Rte 347 Bldg 24
state: New York
Study officials:
affiliation: Ophthalmic Consultants of Long Island
name: John R Wittpenn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05202535: Effect of Aerobic Exercise Training in Obese Adults
Official title: Effect of Aerobic Exercise Training on Arterial Stiffness and Hemodynamics in Obese Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Aerobic exercise, arterial stiffness, hemodynamics, obesity
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effect of aerobic exercise training on arterial stiffness and hemodynamics in obese adults. Proper evidence on the effect of aerobic exercise training on both arterial stiffness and hemodynamics are sparsely present in obese adults whereas separate studies were done in mainly hypertensive and cardiovascular disease populations.

Detailed description: Obese adults always have been trying to improve their quality of life by managing the complications associated with obesity like arterial stiffness and disturbed hemodynamics.

Eligibility criteria: Inclusion Criteria:

* Body mass index ≥28 kg/m²
* Able to do exercise

Exclusion Criteria:

* Involved in structured physical activity in last 6 months
* History of chronic systemic disease (cardiovascular, pulmonary, and metabolic disease)
* Continuous medication use.
* MSK or Neurological problems
* Pregnant females

Primary outcomes:
measure: Arterial Stiffness
timeFrame: 6 weeks
measure: Hemodynamics
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Polyclinic Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Mehwish Waseem, MSPT(CPPT)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hvidt KN. Blood pressure and arterial stiffness in obese children and adolescents. Dan Med J. 2015 Mar;62(3):B5043.
citation: Cote AT, Phillips AA, Harris KC, Sandor GG, Panagiotopoulos C, Devlin AM. Obesity and arterial stiffness in children: systematic review and meta-analysis. Arterioscler Thromb Vasc Biol. 2015 Apr;35(4):1038-44. doi: 10.1161/ATVBAHA.114.305062. Epub 2015 Jan 29.
Clinical trial NCT05873335: In Vivo Pulse Oximeter Validation Study
Official title: In Vivo Testing for SpO2 Accuracy on Healthy Adults Under Laboratory Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Lead sponsor: Gabi SmartCare
Sponsor class: INDUSTRY
First posted: 2023-05-24
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this clinical trial is to compare values of SpO2 provided by the DUT and the SaO2 used as a reference in healthy adults. The main question it aims to answer is: what is the accuracy of the subject device compared to the 510(k)-cleared reference device

A radial arterial cannula was placed in the wrist of each subject for arterial blood sampling and a subject device was placed on each arm of the patients. Then, hypoxia was induced to different stable levels of oxyhemoglobin saturation between 70-100% by having subjects breathe mixtures of nitrogen, air, and carbon dioxide controlled by the study physician. Values of SpO2 and SaO2 were then compared to provide a root mean square error and conclude on the subject device accuracy.


Eligibility criteria: Inclusion Criteria:

* Healthy adult
* Normal hemoglobin levels (Hemoglobin \> 10 g/dL)

Exclusion Criteria:

* Systemic illness
* Obesity

Primary outcomes:
measure: Measure of Accuracy (ARMS [%])
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Hypoxia Research Laboratory
state: California
Study officials:
affiliation: University of California, San Francisco
name: Philip E Bickler, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00625235: A High Protein Diet and Weight Maintenance
Official title: The Use of a High Protein Diet in Achieving Long-Term Weight Loss and Improved Cardiovascular Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Weight loss
Weight maintenance
VLED
Lead sponsor: University of Melbourne
Sponsor class: OTHER
Collaborators: name: Meat and Livestock Australia
First posted: 2008-02-28
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An investigation into long term weight maintenance using a high protein or high carbohydrate diet, after a large and rapid weight loss.


Eligibility criteria: Inclusion Criteria:

* healthy men and women with a BMI \>27kg/m2 with co-morbities or BMI \>30kg/m2

Exclusion Criteria:

* people with Type II diabetes or other endocrine disorders, women who were pregnant or breastfeeding or planning to become pregnant

Primary outcomes:
measure: Body weight
timeFrame: 12 months
Secondary outcomes:
measure: Cardiovascular risk factors
timeFrame: 12 months
Other outcomes:
Locations:
city: Heidelberg
country: Australia
facility: Department of Medicine, Heidelberg Repatriation Hospital
state: Victoria
Study officials:
References:
Clinical trial NCT05738135: Aminophylline on Recovery in Functional Endoscopic Sinus Surgery Under Dexmedetomidine Hypotensive Anesthesia
Official title: Effect of Intravenous Aminophylline on Hemodynamics and Recovery of Patients Undergoing Functional Endoscopic Sinus Surgery Under Dexmedetomidine Hypotensive Anesthesia: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aminophylline
Dexmedetomidine
Functional Endoscopic Sinus Surgery
Keywords: Aminophylline
Dexmedetomidine
Hemodynamics
Recovery
Functional Endoscopic Sinus Surgery
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to evaluate the effect of intravenous aminophylline on hemodynamics and recovery of patients receiving dexmedetomidine infusion during functional endoscopic sinus surgery.

Detailed description: Aminophylline is a nonselective adenosine receptor antagonist used for the treatment of asthma and chronic obstructive pulmonary disease. It has been used to antagonize the effects of anaesthetic and analgesic agents

Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 to 50 years, have American society of anesthesiology (ASA) physical status I - II and scheduled for elective FESS under general anesthesia and receiving dexmedetomidine infusion for controlled hypotension during surgery.

Exclusion Criteria:

1. Patients with central nervous system diseases, cardiovascular diseases, hypertension, arrhythmias, cerebrovascular diseases, convulsions, renal impairment or hepatic dysfunction.
2. Pregnancy or lactation.
3. Patients with a history of allergy to aminophylline.
4. Patients with recurrent sinus surgery, hypertension.

Primary outcomes:
measure: Time to extubation
timeFrame: Two hours after discontinuation of anesthetics
Secondary outcomes:
measure: Intraoperative heart rate
timeFrame: Intraoperative period
measure: Intraoperative mean arterial blood pressure
timeFrame: Intraoperative period
measure: Postoperative sedation score
timeFrame: 60 minutes after tracheal extubation
measure: Time to discharge from post anesthesia care unit
timeFrame: Two hours after tracheal extubation.
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University Hospitals
state: ElGharbiaa
Study officials:
References:
Clinical trial NCT01078935: The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation
Official title: The Effect of Probiotics on Bowel Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Crohn's Disease
Ulcerative Colitis
Keywords: Crohn's disease activity index
CDAI
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Israel
First posted: 2010-03-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Fifty patients will get probiotics (109 bacteria \[L. acidophilus, B. bifidum, S. thermophilus, L. rhamnosus, L. casei\] in 2 capsules) and half will get placebo (2 capsules that look the same like the probiotic capsules and will contain microcrystalline cellulose, artificial brown color, magnesium strearate, and silica dioxide). The patients and the staff will be blinded to the identity of the study medications.

Each patient and volunteer will get the study medication for 6 weeks and will be evaluated twice - before enrollment and after 6 weeks of treatment. Routine clinical management will continue - with regular treatment as needed.

Each individual will be studied for changes in biochemical inflammatory and immunological markers and changes in flow medicated diameter that will be measured by the brachial artery method (that is evaluating endothelial function). Every patient will be evaluated for his/her ability to produce endothelial progenitor stem cells (EPCs).


Eligibility criteria: Inclusion Criteria:

* patients with ulcerative colitis and crohns' disease

Exclusion Criteria:.

* notable caveats are that arteries smaller than 2.5 mm

Primary outcomes:
measure: Truelove and Witts Classification of Ulcerative Colitis
timeFrame: 2 years
measure: Crohn's disease activity index (CDAI)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00929435: Incidence of Methicillin Resistant Staphylococcus Aureus (MRSA) Carriage Rates in Resident Physicians
Official title: The Incidence of Methicillin Resistant Staphylococcus Aureus (MRSA) Nasal Carriage Among Resident Physicians
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: MRSA Colonization
Keywords: MRSA
Contact isolation
Incidence
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2009-06-29
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All newly recruited residents will be eligible for enrollment.

Brief summary: One hundred new residents will be recruited prior to the start of residency and followed prospectively for a year. Monthly nasal swabs will be performed to identify colonization with methicillin resistant staphylococcus aureus (MRSA).The proportion of study subjects colonized with MRSA at the end of 1 year will be calculated.

Detailed description: This is a prospective observational study looking at the incidence of MRSA colonization. New residents will be monitored every month with nasal swabs.We would like to elucidate factors responsible for MRSA colonization in healthcare workers.We would like to see if health care workers who are colonized spontaneously cleared MRSA and if there was any factors involved.

Nasal swabs will be plated on the spot by trained individuals and the plates then incubated for 48 hours. Plates will be read by microbiologist after incubation.

Eligibility criteria: Inclusion Criteria:

* Study subjects will be newly appointed residents at the OU medical center

Exclusion Criteria:

* Previous MRSA infection
* Current use of mupirocin

Primary outcomes:
measure: To detect an increase in MRSA nasal carriage rate among newly appointed residents after 1 year of regular patient contact.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Oklahoma University health science center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Gary T Kinasewitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01787435: Acid-suppressing Drugs Pregnancy Asthma Offspring Study
Official title: A Cohort Study on the Association Between Acid-suppressing Drugs in Pregnancy and Asthma in the Offspring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma in Offspring
Keywords: Asthma,
acid-suppressing drugs,
pregnancy,
epidemiology
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-02-08
Enrollment: 10116
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women aged 18-45 years and with at least one pregnancy between 1 January 1995 and 31 December 2010 who have been enrolled with their PCP (Primary Care Physician) for at least 1 year and have had a health contact in the year prior to the last menstrual period (LMP) of the respective pregnancy. The final study population will include pregnancies that can be unequivocally linked with live birth(s) and only the first pregnancy ascertained during the study period for each woman will be retained

Brief summary: The purpose of this study is

1. To estimate the association between prenatal exposure to proton pump inhibitors (PPIs) and the risk of asthma during childhood.
2. To estimate the association between prenatal exposure to H2-receptor antagonists (H2RAs) and the risk of asthma during childhood.

Detailed description: A cohort study on the association between acid-suppressing drugs in pregnancy and asthma in the offspring

Eligibility criteria: Inclusion Criteria:

- Females aged 18-45 years with at least one pregnancy between 1 January 1995 - 31 December 2010 (see study population description)

Exclusion Criteria:

- Males, females below age 18 and 45 years and above (see study population description)

Primary outcomes:
measure: Relative risk of first asthma diagnosis associated with prenatal exposure to proton pump inhibitors
timeFrame: From 1 January 2005 till 31 December 2010, an expected average of 5 years.
measure: Relative risk of first asthma diagnosis associated with prenatal exposure to histamine-2 receptor antagonists
timeFrame: From 1 January 2005 till 31 December 2010, an expected average of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Research Site
Study officials:
affiliation: CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )
name: Luis A Garcia Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04282135: Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling
Official title: Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Lead sponsor: Klinikum Bayreuth GmbH
Sponsor class: INDUSTRY
First posted: 2020-02-24
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: general population

Brief summary: Multicapillary Ion mobility spectrometry of nasal air aspirates shall be investigated as screening tool for the detection of Influenza and SARS-CoV-2- infection.

Detailed description: Bacterial infections can be distinguished by analysis of the volatile organic compounds found in breath.

In patients with suspected Influenza infection, nasal air samples will be taken and analyzed by Multicapillary Ion mobility spectrometry (MCC IMS). Routinely all patients undergo polymerase chain reaction (PCR) analysis of nasopharyngeal swabs for Influenza.

MCC IMS spectra will be compared between infected and non infected patients by cluster analysis and discrimination analysis.

If the number of infected patients exceeds 50 an additional validation cohort will be investigated sequentially otherwise validation will be performed during the Influenza epidemic 2021.

Due to decreasing numbers of Influenza-A- Infections study was opened to also include patients with suspected SARS-CoV-2 infections.

Eligibility criteria: Inclusion Criteria:

* suspected Influenza infection

Exclusion Criteria:

* later than 48h after admission and detection of Influenza infection
* later than 32 days after admission and detection of SARS-CoV-2- infection
* no written consent

Primary outcomes:
measure: Cluster Analysis of MCC IMS spectra.
timeFrame: immediatly after sampling
Secondary outcomes:
Other outcomes:
Locations:
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth
Study officials:
affiliation: Klinikum Bayreuth, Dpt. Pulmonology
name: Claus Steppert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steppert C, Steppert I, Sterlacci W, Bollinger T. Rapid detection of SARS-CoV-2 infection by multicapillary column coupled ion mobility spectrometry (MCC-IMS) of breath. A proof of concept study. J Breath Res. 2021 Mar 18;15(2). doi: 10.1088/1752-7163/abe5ca.
citation: Steppert C, Steppert I, Bollinger T, Sterlacci W. Rapid non-invasive detection of Influenza-A-infection by multicapillary column coupled ion mobility spectrometry. J Breath Res. 2020 Oct 22;15(1):011001. doi: 10.1088/1752-7163/abb762.
Clinical trial NCT00688935: Young Blind Child Melatonin Treatment Study
Official title: Identification of Free-Running Rhythms in Blind Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Blindness
Keywords: melatonin
circadian rhythms
sleep
sleep disorders
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2008-06-03
Enrollment: 9
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary goal of this study is to identify the presence of desynchronized circadian rhythms in 25 children by measuring melatonin secretion in serial blood or saliva samples, and to rule out any primary sleep disorders.

Detailed description: Subjects will complete 25-hours of hourly salivary, plasma sampling biweekly. Melatonin will be measured in urine, for children under the age of 3. Sleep and behavioral questionnaires will be completed by parents and/or teachers. This study involves an optional, 1-year melatonin treatment sub-study, in which the children will take 0.1 - 3mg daily. A second optional sub-study involves a study of the child's sleep through polysomnography, in order to identify possible sleep disorders.

Eligibility criteria: Inclusion Criteria:

* Age 1-20 years
* Blindness for the past year (verified by an ophthalmologic exam), but otherwise in general good health.

Exclusion Criteria:

* Abnormal heart, lung, kidney, liver disease or a primary sleep disorder,
* Significant clinical abnormalities (other than blindness),
* Use of medications with known effects on melatonin metabolism (e.g. beta-adrenergic blocking drugs or tricyclic antidepressants).

Primary outcomes:
measure: Circadian Phase Marker, as Measured by the Melatonin Levels in Salivary, Plasma and/or Urine Serial Sampling.
timeFrame: every 2-4 weeks throughout the entire study
Secondary outcomes:
measure: Polysomnography (Sleep Assessment)
timeFrame: 1 12-hour assessment any time during the study
Other outcomes:
Locations:
city: Portland
country: United States
facility: Sleep and Mood Disorders Lab, Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Alfred J Lewy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palm L, Blennow G, Wetterberg L. Long-term melatonin treatment in blind children and young adults with circadian sleep-wake disturbances. Dev Med Child Neurol. 1997 May;39(5):319-25. doi: 10.1111/j.1469-8749.1997.tb07438.x.
citation: Sack RL, Lewy AJ, Blood ML, Keith LD, Nakagawa H. Circadian rhythm abnormalities in totally blind people: incidence and clinical significance. J Clin Endocrinol Metab. 1992 Jul;75(1):127-34. doi: 10.1210/jcem.75.1.1619000.
citation: Tzischinsky O, Skene D, Epstein R, Lavie P. Circadian rhythms in 6-sulphatoxymelatonin and nocturnal sleep in blind children. Chronobiol Int. 1991;8(3):168-75. doi: 10.3109/07420529109063923.