louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04878042: COVID-19 Infection Control Using H2O2 Mouth Wash and Nasal Spray
Official title: The Negativisation Rate of Positive PCR Swab Tests for the Detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) After Treatment With Hydrogen Peroxide: a Double-blind Placebo-controlled Randomised Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COVID-19
Lead sponsor: EPISTATA
Sponsor class: NETWORK
First posted: 2021-05-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hydrogen peroxide is produced physiologically by oral bacteria and plays a significant role in the balance of oral microecology since it is an important antimicrobial agent. In the epithelial cells, the enzyme superoxide dismutase catalyzes a reaction leading from hydrogen peroxide to the ion superoxide. The induced oxidative stress stimulates a local innate response via activation of the toll-like receptors and the NF-κB. Those kinds of reactions are also activated by viral infections. Virus-induced oxidative stress plays an important role in the regulation of the host immune system and the specific oxidant-sensitive pathway is one of the effective strategies against viral infections. Therefore, nose/mouth/throat washing with hydrogen peroxide may enhance those local innate responses to viral infections. The investigators hypothesised that a treatment with a mouth wash and a nasal spray containing a diluted solution of hydrogen peroxide may accelerate the negativisation rate of a positive PCR swab test for SARS-CoV-2 (COVID-19).


Eligibility criteria: Inclusion Criteria:

- recent positive SARS-CoV-2 PCER swab test

Exclusion Criteria:

- severe Covid19 disease

Primary outcomes:
measure: The negativisation rate of a positive SARS-CoV-2 (COVID-19) PCR nose swab test
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Clinica Nuova ITOR
Study officials:
affiliation: EPISTATA
name: Antonio I Lazzarino, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01040442: The Effect of Plantar Vibration Stimuli on the Balance of Older Women
Official title: The Effect of Plantar Vibration Stimuli on the Balance of Older Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deficit Elderly Women With Body Balance
Keywords: Postural Balance
Aging
Accidental Falls
Vibration
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2009-12-29
Enrollment: 30
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the present study was to identify the effect of direct vibration at a frequency of 100 Hz, applied to the plantar region, on the balance of women aged 60 years or older. The hypothesis is that the place improves body balance.


Eligibility criteria: Inclusion Criteria:

* women aged 60 or older, static balance deficit verified by the One-Leg Stance test with eyes open (OLSeo) (inability to maintain position for 30 seconds with eyes open, which is associated with the risk of falling17), independent gait without the use of walking aids.

Exclusion Criteria:

* individuals undergoing treatment to improve balance, inability to understand verbal commands, pathologies that affect balance and gait, use of medication that may affect balance, lower limb surgery in the past 12 months or participation in a physical activity program.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Wanderley FS, Alburquerque-Sendin F, Parizotto NA, Rebelatto JR. Effect of plantar vibration stimuli on the balance of older women: a randomized controlled trial. Arch Phys Med Rehabil. 2011 Feb;92(2):199-206. doi: 10.1016/j.apmr.2010.10.014.
Clinical trial NCT00747942: Support for Increased Physical Activity (Stöd Till Aktivare Motion)
Official title: Intervention Program for Physically Inactive and Overweight Immigrant Women From the Middle East and Latin America Living in Sweden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: overweight
physical inactivity
physical fitness
lifestyle change
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2008-09-08
Enrollment: 234
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to improve and analyze the level of physical activity in immigrant women from the Middle East and Latin America living in Sweden. The investigators will also investigate if glucose, insulin, and lipid metabolism; stress-related hormone production; and subclinical inflammatory activity are affected by the intervention. The follow-up period is 2 years.


Eligibility criteria: Inclusion Criteria:

* Female gender
* Age 25 through 64 years
* Physical inactivity
* BMI \> 25
* Immigrant to Sweden from either the Middle East or Latin America

Exclusion Criteria:

* Diabetes mellitus type I
* Ischemic heart disease
* Disability that interferes with the ability to participate in lifestyle-related physical activity

Primary outcomes:
measure: The relative effectiveness of two physical activity programs in affecting glucose metabolism, lipid metabolism and stress-related hormone production
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Center for Family and Community Medicine
state: Stockholm
Study officials:
affiliation: Karolinska Institutet
name: Jan Sundquist, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Sundquist J, Hagstromer M, Johansson SE, Sundquist K. Effect of a primary health-care-based controlled trial for cardiorespiratory fitness in refugee women. BMC Fam Pract. 2010 Aug 2;11:55. doi: 10.1186/1471-2296-11-55.
Clinical trial NCT04675242: Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension for the Treatment of Blepharitis
Official title: Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of NCX 4251 Ophthalmic Suspension, 0.1% QD for the Treatment of Acute Exacerbations of Blepharitis (Mississippi)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Blepharitis
Lead sponsor: Nicox Ophthalmics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-19
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, double-masked, placebo-controlled, Phase 2b trial evaluating the safety and efficacy of NCX 4251 (fluticasone propionate nanocrystal) Ophthalmic Suspension 0.1% QD for the treatment of acute exacerbations of blepharitis.


Eligibility criteria: Inclusion Criteria:

* documented history of blepharitis and meet qualifying criteria for an acute exacerbation of blepharitis in both eyes at Screening and Baseline/Day 1 Visits
* have a qualifying best-corrected visual acuity

Exclusion Criteria:

* abnormality of the eyelids or lashes (other than blepharitis), or previous eyelid surgery
* IOP \> 21 mmHg at Screening or Baseline/Day 1 Visits
* use of steroids in the past 30 days or retinoids in the past 12 months
* uncontrolled systemic disease

Primary outcomes:
measure: Percentage of Study Eyes With Complete Cure (Score 0) of Blepharitis Signs and Symptoms at Day 15
timeFrame: Day 15 Visit
Secondary outcomes:
measure: Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Symptoms
timeFrame: Day 15 Visit
measure: Mean Change From Baseline to Day 15 in Study Eye Eye Dryness Sign (Fluorescein Staining of the Inferior Cornea)
timeFrame: Day 15 Visit
measure: Treatment-emergent Adverse Events
timeFrame: 29 days
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
Study officials:
affiliation: Nicox Ophthalmics, Inc.
name: Nicox Ophthalmics
role: STUDY_DIRECTOR
References:
Clinical trial NCT01791842: TOCILIZUMAB IN FIBROUS DYSPLASIA OF BONE
Official title: TREATMENT OF FIBROUS DYSPLASIA OF BONE WITH TOCILIZUMAB AMONG PATIENTS WHO DO NOT RESPOND TO BISPHOSPHONATES. THE TOCIDYS TRIAL.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibrous Dysplasia of Bone
Keywords: fibrous dysplasia of bone
tocilizumab
McCune-Albright syndrome
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Bone pain due to fibrous dysplasia of bone is usually treated with bisphosphonates. A small proportion of patients fail to respond adequately. Mutated bone cells produce large amounts of Interleukin-6 (IL-6), with increased bone resorption as a result. Inhibition of IL-6 may be of interest to reduce bone resorption and therefore bone pain. TOCIDYS is a placebo-controlled randomized cross-over trial to test the hypothesis that tocilizumab can reduce bone resorption in those patients with fibrous dysplasia who have already received bisphosphonates.


Eligibility criteria: Inclusion Criteria:

* fibrous dysplasia of bone
* previously treated with IV bisphosphonates
* persistent bone pain and increased bone remodeling

Exclusion Criteria:

* Chronic renal failure
* serious infectious diseases
* liver enzymes abnormality
* pregnancy
* dyslipidemia

Primary outcomes:
measure: serum CTX (type 1 collagen C-terminal breakdown product)
timeFrame: 6 months
Secondary outcomes:
measure: Bone pain
timeFrame: 6 months
measure: serum ICTP (Carboxyterminal Telopeptide of Type I Collagen)
timeFrame: 6 months
measure: bone alkaline phosphatase
timeFrame: 6 months
measure: radiographs of mostly affected area
timeFrame: 12 months
Other outcomes:
measure: Biological safety
timeFrame: 12 months
Locations:
city: Bordeaux
country: France
facility: Service de Rhumatologie, Groupe Hospitalier Pellegrin
city: Lyon
country: France
facility: Service de rhumatologie, Hopital Edouard Herriot, HCL
city: Paris
country: France
facility: Service de rhumatologie, Hôpital Lariboisière
Study officials:
References:
Clinical trial NCT01997242: The Surgery After Stenting (SAS) Registry
Official title: A Multicenter Registry of Consecutive Patients Undergoing Cardiac and Noncardiac Surgery or Operative Endoscopic/Endovascular Procedures After Implantation of a Coronary Stent
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PERCUTANEOUS CORONARY INTERVENTION
STENTS
SURGERY
Keywords: CORONARY STENT
CARDIAC SURGERY
NON CARDIAC SURGEY
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
Collaborators: name: Italian Society of Invasive Cardiology
name: Associazione Nazionale Medici Cardiologi Ospedalieri
First posted: 2013-11-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with prior coronary stenting undergoing urgent or elective surgical/endoscopic procedures

Brief summary: The SAS registry will include any patient with previous coronary stenting undergoing any type of surgery or operative endoscopic/endovascular procedure at the participating Centers. The relevant clinical, procedural and outcome data (within index surgical admission and at 30 days) will be entered in a specifically designed electronic case record form (eCRF).


Eligibility criteria: Inclusion Criteria:

* Eligible will be male and female patients \> 18 years of age.
* Eligible will be patients with previous coronary stenting undergoing any kind of surgical or operative endoscopic procedure at the participating Centers, irrespective of the distance in time between stenting and surgery.
* Both candidates to elective/urgent operations and those undergoing emergency operations will be included in the SAS registry, and will be considered as two separate cohorts.

Exclusion Criteria:

- Unwillingess/inability to sign the Informed Consent Form (ICF). There are no other selection criteria.

Primary outcomes:
measure: The composite of death, myocardial infarction, probable/definite stent thrombosis according the Academic Research Consortium definition and bleeding events of Bleeding Academic Research Consortium (BARC)grade >3 during index surgical admission.
timeFrame: within the first 30 days after surgery
Secondary outcomes:
measure: The incidence of bleeding events of Bleeding Academic Research Consortium (BARC) grade >3 within 30 days of index admission/procedure
timeFrame: within the first 30 days after surgery
Other outcomes:
Locations:
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova- IRCCS
Study officials:
affiliation: Division of Cardiology, Manzoni Hospital, Lecco
name: Stefano Savonitto, MD
role: STUDY_CHAIR
affiliation: Cardiovascular Dpt, Ospedali Riuniti di Bergamo
name: Roberta Rossini, MD
role: STUDY_CHAIR
affiliation: Arcispedale Santa Maria Nuova - IRCCS, Reggio Emilia
name: Giovanni Tortorella, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04814342: Accuracy of Pulse Oximeters With Profound Hypoxia During Motion
Official title: Determination of SpO2 and PR Accuracy Specifications During Motion Accuracy of Pulse Oximeters With Profound Hypoxia Pulse Oximeter Accuracy Evaluation Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia
Lead sponsor: Nihon Kohden
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2021-03-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers. At least 5 subjects will be recruited to complete the study. Of these, 2 will be dark pigmented.

Brief summary: The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients during controlled motion.

Detailed description: This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients during controlled motion.

Eligibility criteria: Inclusion Criteria:

* Both male and female subjects who can give written informed consent
* Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile
* Meeting the demographic requirements

Exclusion Criteria:

* Age below 18 or over 50
* Pregnant women
* Significant arrhythmia
* Blood pressure above 150 systolic or 90 diastolic
* Subjects whom the investigator consider ineligible for the study

Primary outcomes:
measure: Accuracy of Sensor Oxygen Saturation by Arms Calculation
timeFrame: 30 seconds
Secondary outcomes:
measure: Accuracy of Sensor Pulse Rate by Arms Calculation
timeFrame: 30 seconds
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Hypoxia Research Laboratory
state: California
Study officials:
affiliation: UCSF Hypoxia Research Laboratory
name: Philip Bickler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06243042: Vitamin D Serum Levels in Monosymptomatic Enuretic and Non Enuretic Children
Official title: A Comparative Study of Vitamin D Serum Levels in Monosymptomatic Enuretic Children and Non-enuretic Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nocturnal Enuresis
Keywords: Nocturnal enuresis
Vitamin D
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: male and female children from 5-15 years wer selcted in two groups 60 enuretic children 60 non enuretic children as a control group

Brief summary: We are group of researchers interested in causes and management of nocturnal enuresis, we embarked on this research on 2020 and we reached promising results regarding the role of vitamin D serum level in etiology and management of monosymptomatic enuresis.

Detailed description: this research was conducted as a comparative study regarding serum vitamin D levels in monosymptomatic enuretic and non enuretic children, also we compared urine osmolality and nocturnal polyuria in both groups and we found that low vitamin D levels are correlated with low nocturnal urine osmolality and increased incidence of nocturnal polyuria

Eligibility criteria: Inclusion Criteria:

* Patients with PMNE.
* which was defined as bedwetting frequency of 3 or more nights per week for at least 2 weeks of observation.
* Didn't receive any previous treatment for enuresis.

Exclusion Criteria:

* Patients with non-monosymptomatic enuresis (associated with storage and/or voiding symptoms). -Patients with anatomical abnormalities (Meatal stenosis, Hypospadias, Epispadias, etc.).
* Patients with neurological diseases.
* Patients with Renal impairment.
* Patient with previous pelvic, urological or brain and spinal cord surgery.
* Patients with chronic constipation and irritable bowel habits.
* Patients with active urinary tract infection.
* Patients who are on vitamin D supplements.

Primary outcomes:
measure: Vitamin D level
timeFrame: through study completion, average 1 year.
Secondary outcomes:
measure: nocturnal polyuria
timeFrame: through study completion, average 1 year.
measure: low nocturnal urine osmolality
timeFrame: through study completion, average 1 year.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo
Study officials:
affiliation: Ain Shams University
name: diaa mostafa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04238442: Assessing the Accuracy of the A&D TM-2657W Oscillometric Device
Official title: Assessing the Accuracy of the A&D TM-2657W Oscillometric Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: A&D Medical
First posted: 2020-01-23
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The A\&D automatic blood pressure device is a new kiosk that can measure blood pressure in the general population.

The investigators plan to use the existing International Standards Organization validation protocol to determine whether this device measures blood pressure accurately.

Detailed description: Methods and Analysis

Study methodology will follow the ISO protocol:

* 85 adult (age 18 years or greater) subjects will be included (it is estimated that approximately 140 subjects will need to be screened as some will be ineligible). 85 is the recommended sample size for validation studies using the ISO protocol.
* Subjects will be recruited via an existing registry of over 250 individuals that have participated in past measurement studies, through advertisements, and from the University of Alberta Hypertension Clinic.
* Specific requirements for a certain percentage of subjects with specific age, sex, upper arm circumference, and baseline blood pressure levels will be observed to ensure that a representative sample is studied (according to the ISO standards).
* Subjects that are pregnant or with atrial fibrillation will be excluded. Blood pressure measurements will be taken using recommended, optimal technique.
* Nine measurements will be taken in each subject, alternating between blinded two-observer auscultation with a mercury-based sphygmomanometer (the reference standard) and the TM-2657. Careful attention will be paid to ensuring proper cuffing. The first two measurements will be discarded and the latter seven measurements (4 auscultatory and TM-2657 measurements) will be used in the analysis, which will be conducted according to ISO standards.
* Accuracy will be assessed according to Criterion 1 and 2 of the ISO standard. Bland-Altman plots will be generated. A plot of measurement error versus arm circumference will be generated as well.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* normal sinus rhythm
* have capacity to give consent
* following the International Standards Organization criteria for: gender distribution, limb size, blood pressure distribution

Exclusion Criteria:

* atrial fibrillation
* pregnancy

Primary outcomes:
measure: Accuracy per International Standards Organization Protocol
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Jennifer Ringrose, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00051142: A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)
Official title: A Safety and Efficacy Study of Travoprost 0.004% Compared to Latanoprost 0.005% in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Keywords: Glaucoma
POAG
OAG
OHT
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2003-01-07
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and IOP-lowering efficacy of Travoprost (0.004%) compared to Latanoprost (0.005%) in patients with chronic open-angle glaucoma or ocular hypertension.


Eligibility criteria: Adult patients of any race and either sex with open-angle glaucoma (with or without pigment dispersion or pseudoexfoliation component) or ocular hypertension.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Latin America
state: Texas
Study officials:
affiliation: Alcon Research
name: Alcon Investigators
role: PRINCIPAL_INVESTIGATOR
References: