louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02238132: Postmarketing Surveillance Study of Atrovent® Inhalets in Chronic Obstructive Airways Disease
Official title: Postmarketing Surveillance Study (as Per §67(6)AMG[German Drug Law]) of Atrovent® Inhalets in Chronic Obstructive Airways Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-12
Enrollment: 374
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 chronic obstructive airways disease recruited at general practitioners, pneumologists, internists

Brief summary: To obtain further information on the tolerability of Atrovent® inhalets in the treatment of Chronic Obstructive Airways Disease under conditions of daily practice


Eligibility criteria: Inclusion Criteria:

* Primarily, Patients with chronic obstructive airways disease
* Only patients who had not been treated with Atrovent® in the last year were to be considered for inclusion

Exclusion Criteria:

- Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® inhalets

Primary outcomes:
measure: Investigator assessment of improvement in the clinical picture of the course on a 6-point symptoms profile
timeFrame: Up to 4 weeks after first study drug administration
Secondary outcomes:
measure: Investigator assessment of efficacy on a 4-point scale
timeFrame: Up to 4 weeks after first study drug administration
measure: Investigator assessment of tolerability on a 4-point scale
timeFrame: Up to 4 weeks after first study drug administration
measure: Number of patients with adverse drug reactions
timeFrame: Up to 4 weeks after first study drug administration
measure: Number of patients who withdrew from the study
timeFrame: Up to 4 weeks after first study drug administration
measure: Number of patients who changed the concomitant medication
timeFrame: Up to 4 weeks after first study drug administration
measure: Number of patients who continued the treatment
timeFrame: Up to 4 weeks after first study drug administration
measure: Patient assessment of efficacy on a 4-point scale
timeFrame: Up to 4 weeks after first study drug administration
measure: Patient assessment of tolerability on a 4-point scale
timeFrame: Up to 4 weeks after first study drug administration
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02254837: Zilver PTX Post-Market Study in Japan
Official title: Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease (PAD)
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2014-10-02
Enrollment: 909
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Japanese post market clinical study of the Zilver PTX device.


Eligibility criteria: Inclusion Criteria:

* Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries

Primary outcomes:
measure: Occurrence of stent fracture
timeFrame: 5 years
measure: Rate of adverse events
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Cardiothoracic Surgery, Stanford University Medical Center, Stanford, CA
name: Michael D Dake, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sugimoto M, Komori K, Yokoi H, Ohki T, Kichikawa K, Nakamura M, Nanto S, O'Leary EE, Lottes AE, Saunders AT, Dake MD. Long-Term Effectiveness of a Drug-Eluting Stent for Femoropopliteal In-Stent Restenosis: Subanalysis of the Zilver PTX Japan Post-Market Surveillance Study. J Endovasc Ther. 2021 Apr;28(2):229-235. doi: 10.1177/1526602820966708. Epub 2020 Oct 21.
citation: Dake MD, Fanelli F, Lottes AE, O'Leary EE, Reichert H, Jiang X, Fu W, Iida O, Zen K, Schermerhorn M, Zeller T, Ansel GM. Prediction Model for Freedom from TLR from a Multi-study Analysis of Long-Term Results with the Zilver PTX Drug-Eluting Peripheral Stent. Cardiovasc Intervent Radiol. 2021 Feb;44(2):196-206. doi: 10.1007/s00270-020-02648-6. Epub 2020 Oct 6.
citation: Kichikawa K, Ichihashi S, Yokoi H, Ohki T, Nakamura M, Komori K, Nanto S, O'Leary EE, Lottes AE, Snyder SA, Dake MD. Zilver PTX Post-market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 2-Year Results. Cardiovasc Intervent Radiol. 2019 Mar;42(3):358-364. doi: 10.1007/s00270-018-2110-1. Epub 2018 Nov 8.
citation: Yokoi H, Ohki T, Kichikawa K, Nakamura M, Komori K, Nanto S, O'Leary EE, Lottes AE, Snyder SA, Dake MD. Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 12-Month Results. JACC Cardiovasc Interv. 2016 Feb 8;9(3):271-277. doi: 10.1016/j.jcin.2015.09.035.
Clinical trial NCT01841437: Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry
Official title: Glaukos® iStent® Trabecular Micro-Bypass Stent System In Conjunction With Cataract Surgery Postmarket Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Open-angle Glaucoma
Keywords: Primary open-angle glaucoma (POAG)
Trabecular meshwork
iStent
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2013-04-26
Enrollment: 191
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive subjects in whom implantation of the iStent is attempted at selected clinical sites

Brief summary: The purpose of this study is to observe the safety of the Glaukos® iStent® Trabecular Micro-Bypass Stent Model GTS100 in conjunction with cataract surgery in subjects with mild to moderate open-angle glaucoma.


Eligibility criteria: Inclusion Criteria:

* Consecutive subjects in whom implantation of the iStent is attempted

Exclusion Criteria:

* Please refer to approved indications in Directions for Use

Primary outcomes:
measure: Rate of sight-threatening adverse events
timeFrame: 36 months
Secondary outcomes:
measure: Other ocular adverse events
timeFrame: 36 months
Other outcomes:
Locations:
city: Chico
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Napa
country: United States
state: California
city: Santa Maria
country: United States
state: California
city: Ventura
country: United States
state: California
city: Parker
country: United States
state: Colorado
city: Portland
country: United States
state: Maine
city: Quincy
country: United States
state: Massachusetts
city: Bloomington
country: United States
state: Minnesota
city: Westwood
country: United States
state: New Jersey
city: Durham
country: United States
state: North Carolina
city: Fayetteville
country: United States
state: North Carolina
city: Southern Pines
country: United States
state: North Carolina
city: Brecksville
country: United States
state: Ohio
city: Youngstown
country: United States
state: Ohio
city: Ladson
country: United States
state: South Carolina
city: Sioux Falls
country: United States
state: South Dakota
city: Appleton
country: United States
state: Wisconsin
Study officials:
References:
Clinical trial NCT00742937: Impact of Maternal Supplementation With Dual Megadose of Vitamin A
Official title: Impact of Supplementation With Dual Megadose of Vitamin A in the Post-partum About Vitamin A Levels in Breast Milk, Serum Levels of Vitamin A and Iron in the Binomial Mother-son and Growth and Morbidity of Children Under 6 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hypovitaminosis
Vitamin A Deficiency
Keywords: Hypovitaminosis A
Lead sponsor: Instituto Materno Infantil Prof. Fernando Figueira
Sponsor class: OTHER
First posted: 2008-08-28
Enrollment: 239
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the effect of maternal supplementation with 400,000 IU of oral retinol palmitate in the post-partum, the nutritional situation of the binomial mother-child, on growth and morbidity of children in breastfeeding in the first six months of life.

Detailed description: The effect will be assessed by the milk and blood.

Eligibility criteria: Inclusion Criteria:

* Pregnant low-risk obstetric

Exclusion Criteria:

* Premature birth
* Newborn babies with birth defects and / or other serious diseases

Primary outcomes:
measure: Seric retinol
timeFrame: six months
Secondary outcomes:
measure: Morbidity and growth of the child.
timeFrame: six months
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Instituto Materno Infantil Prof. Fernando Figueira
state: Pernambuco
Study officials:
name: Ilma Kruze, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tomiya MT, de Arruda IK, da Silva Diniz A, Santana RA, da Silveira KC, Andreto LM. The effect of vitamin A supplementation with 400 000 IU vs 200 000 IU on retinol concentrations in the breast milk: A randomized clinical trial. Clin Nutr. 2017 Feb;36(1):100-106. doi: 10.1016/j.clnu.2015.11.018. Epub 2015 Dec 17.
citation: Dos Santos CS, Kruze I, Fernandes T, Andreto LM, Figueiroa JN, Diniz Ada S. The Effect of a Maternal Double Megadose of Vitamin A Supplement on Serum Levels of Retinol in Children Aged under Six Months. J Nutr Metab. 2013;2013:876308. doi: 10.1155/2013/876308. Epub 2013 Dec 24.
citation: Fernandes TF, Figueiroa JN, Grande de Arruda IK, Diniz Ada S. Effect on infant illness of maternal supplementation with 400 000 IU vs 200 000 IU of vitamin A. Pediatrics. 2012 Apr;129(4):e960-6. doi: 10.1542/peds.2011-0119. Epub 2012 Mar 12.
Clinical trial NCT06700837: Hypoxic Burden and Sleepiness in Treated OSA Patients
Official title: Impact of Hypoxic Burden on Objective and Subjective Sleepiness in Patients Treated for Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep
OSA
Keywords: Polysomnography
Polygraphy
Hypoxic burden
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study involves consecutive adult patients referred to the Center for Sleep and Respiratory Medicine for performance of MCT from September 2017 to January 2020.

Brief summary: The Maintenance of Wakefulness Test (MWT) is widely used to objectively assess sleepiness and make safety-related decisions and Epworth Sleepiness Scale (ESS) is the most used scale used to assess subjective sleepiness in sleep medicine.

Besides Obstructive Sleep Apnea measures are rapidly evolving and conventional measures such as apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) are increasingly being supplemented by measures of hypoxia such as hypoxic burden.

Residual AHI in treated OSA have limited predictive value for objective sleepiness. Therefore it seems particularly relevant to identify other predictors of both subjective and objective sleepiness.

This study aims at studying the influence of hypoxic burden as measure of both subjective or objective sleepiness.

We hypothesize that impaired nocturnal oxygenation might influence brain functioning during wakefulness and result in sleepiness as assessed by ESS and MWT.


Eligibility criteria: Inclusion Criteria:

* OSA hospitalised to undergo both polysomnography (PSG) and the 40-min MWT in the Center for Sleep Medicine and Respiratory Disease, Lyon Academic Hospital from September 2017 to March 2020.

Exclusion Criteria:

* - age \&lt;18 years
* refusal to participate in the study
* diagnosis of central disorder of hypersomnolence
* missing data on the MWT
* Epworth Sleepiness Scale (ESS)
* apnea-hypopnea index (AHI).

Primary outcomes:
measure: Objective residual sleepiness in a treated OSAHS population as measured by the Multiple Sleep Latency Test (MSLT) in relation to hypoxic load.
timeFrame: 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de médecine du sommeil et des maladies respiratoires Hôpital de la Croix-Rousse
Study officials:
affiliation: Service de médecine du sommeil et des maladies respiratoires Hôpital de la Croix-Rousse
name: Dr Pierre TANKERE, MD, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02854137: Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes
Official title: Evaluation of the Irritation Potential of Sunscreen Products in Human Eyes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-08-03
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Evaluation of the human eye irritation potential of a test sunscreen formulation.


Eligibility criteria: Inclusion Criteria:

* Subjects must be healthy males or females between the ages of 18 to 60 years inclusive.
* Subjects do not wear contact lenses or willing to refrain from wearing them during the day of and day after the study.
* Subjects are willing to report any medications taken during the study and refrain from taking any medication during the study.
* Subjects are willing to have the test materials instilled into the eyes and follow all protocol requirements.

Exclusion Criteria:

* Subjects have ocular disease or peri-orbital dermatitis or trauma.
* Subjects have a systemic illness which contra-indicates participation.
* Subjects must not have a history of pre-existing sensitivity or other types of allergy to any eye products.
* Subjects must not have a history of allergies or sensitivities to cosmetics, toiletries, dermatological products, or any ingredients contained in the test or control products.

Primary outcomes:
measure: Macroscopic evaluations for Lacrimation (score 0-4)
timeFrame: up to 1 hour post instillation
measure: Macroscopic evaluations for Bulbar Conjuctiva Irritation (score 0-3)
timeFrame: up to 1 hour post instillation
measure: Macroscopic evaluations of Palpebral Conjunctiva Irritation (score 0-3)
timeFrame: up to 1 hour post instillation
measure: Subjective assessment of discomfort (score 0-4)
timeFrame: up to 1 hour post instillation
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
state: Florida
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03794037: Montelukast for Prevention & Treatment of OHSS
Official title: Montelukast for Prevention & Treatment of Ovarian Hyperstimulation Syndrome in Freeze-all Cycles
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: Ovarian Hyperstimulation Syndrome
Keywords: ovarian hyperstimulation syndrome
Montelukast
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: Hawaa Fertility Center
First posted: 2019-01-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: montelukast \& dydrgesteron will be given to cases with suspected or proven ovarian hyperstimulation in one group in comparison with dydrogesteron alone in the other group.

Detailed description: patients with high risk for ovarian hyperstimulation will undergo a freeze-all protocol then montelukast \& dydrgesteron will be given to cases with suspected or proven ovarian hyperstimulation in one group in comparison with dydrogesteron alone in the other group.

Eligibility criteria: Inclusion Criteria:

* PCOS high responders high numbers of ovum retrieved

Exclusion Criteria:

* hypersensitivity to any drug components phenylketonuria patients depression liver dysfunction

Primary outcomes:
measure: Number of Participants who develop ovarian hyperstimulation syndrome
timeFrame: 0-14 days
Secondary outcomes:
measure: Number of Participants treated of ovarian hyperstimulation syndrome
timeFrame: 0-14 days
Other outcomes:
Locations:
city: Banha
country: Egypt
facility: Banha University- Hawaa Fertility center
state: Qalyubiya
Study officials:
affiliation: Hawaa Fertility Center
name: ahmed sa saad, MD, ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06098937: Kalifilcon A Toric Compared to Commercially Available Lenses
Official title: Orientation Characteristics of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Commercially Available Daily Disposable Toric Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Keywords: Contact Lens
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2023-10-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Approximately thirty contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study.

Detailed description: Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If study eligibility is met, subjects will have lenses inserted in random, successive order. Subjects will be receiving each of the study lens types once, in a randomized order. The subject will wear each of the study contact lenses for approximately 10 minutes.

Eligibility criteria: Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis.
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent.

Exclusion Criteria:

1. Participating in a conflicting study in the opinion of the Investigator.
2. Considered by the Investigator to not be a suitable candidate for participation

Primary outcomes:
measure: Primary Gaze Orientation for 5 Minutes
timeFrame: 5 minutes after lens insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb, Incorporated
state: New York
Study officials:
References:
Clinical trial NCT06473337: Vitamin D Deficiency as Independent Predictor for Plaque Vulnerability
Official title: Vitamin D Deficiency as Independent Predictor for Plaque Vulnerability and All-cause Mortality in Patients With Symptomatic Carotid Artery Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Carotid Artery Diseases
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with carotid arteriosclerosis willing to perform surgery

Brief summary: Role of vitamin D in cardiovascular disease is controversial. Here the investigators aimed to investigate the association of vitamin D deficiency and carotid plaque morphology as well as outcome of participants with high-grade carotid artery stenosis undergoing carotid endarterectomy.

332 consecutive participants undergoing carotid endarterectomy for symptomatic or asymptomatic carotid artery stenosis, were prospectively included in the study, and vitamin D levels were determined prior to surgery using chemiluminescence-immunoassay.

Detailed description: Role of vitamin D in cardiovascular disease is controversial. Here the investigators aimed to investigate the association of vitamin D deficiency and carotid plaque morphology as well as outcome of participants with high-grade carotid artery stenosis undergoing carotid endarterectomy.

332 consecutive participants undergoing carotid endarterectomy for symptomatic or asymptomatic carotid artery stenosis, were prospectively included in the study, and vitamin D levels were determined prior to surgery using chemiluminescence-immunoassay.

There is insufficient data on cardiovascular outcome in participants with CAS and vitamin D deficiency. Vitamin D would be an easily modifiable factor.

Primary goal was to investigate the influence of vitamin D levels on plaque vulnerability, major adverse cardiovascular events (MACE) and all-cause mortality in patients with carotid artery disease undergoing carotid endarterectomy.

Eligibility criteria: Inclusion Criteria:

* Carotid arteriostenosis
* Patient eligible for carotid artery surgery

Exclusion Criteria:

* Oncologic disease
* Patients with hemorrhagic, lacunar or cardioembolic stroke

Primary outcomes:
measure: Vitamin D levels and its correlation with plaque vulnerability
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Vitamin D levels and its correlation with cardiac outcome
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of General Surgery, Division of Vascular Surgery
Study officials:
affiliation: Medical University of Vienna, Department of General Surgery, Division of Vascular Surgery
name: Christoph Neumayer, MD,Prof.
role: STUDY_DIRECTOR
References: