louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01926704: MTF Image Modifications
Official title: A Pilotstudy Investigating the Impact of Image Modifications on Subjective Image Quality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Modulation Transfer Function
Visual Acuity
Contrast Sensitivity
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2013-08-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy, male and female subjects 18-35 years non-smokers

Brief summary: Human visual acuity and contrast sensitivity are highly dependent on various different parameters. Each should be optimized for perfect visual performance. However, in real life our eyes lack such parameters, which might lead to unsatisfying results even after spectacle correction or contact lenses.

A promising approach would be to design intra ocular lenses (IOL), which are implanted into the eye for example in the course of cataract extraction and are able to compensate for the human eyes' aberrations.

For example cutoff frequency, edge-sharpness or specific contrast for selected structure sizes would need to be considered. Since, an aberration free optical system is almost impossible and since the impact of each single parameter is not yet known, IOL design parameters would have to be chosen very carefully.

Furthermore, image quality of IOLs still is tested ex vivo by ray tracing for example, but this does not guarantee perfect function after implantation, as our visual system has complex image precessing units form the retina to the brain.

The present study picks one of these parameters and seeks to assess its impact on visual quality in-vivo. By subjectively grading different images with objective changes to image quality by variations of the modulation transfer function (MTF), the potential influence and thus on our subjective visual impression shall be assessed.


Eligibility criteria: Inclusion Criteria:

* Men and women aged between 18 and 35 years, nonsmokers
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, emmetropia or ≤ 1 diopter

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug (except oral contraceptives)
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day

Primary outcomes:
measure: subjective image quality
timeFrame: 1 study day
Secondary outcomes:
measure: subjective image sharpness
timeFrame: 1 study day
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
References:
Clinical trial NCT02893904: EEG Profiles During General Anesthesia : a Comparative Study Between Sevoflurane and Propofol
Official title: Electroencephalographic Profiles During General Anesthesia : a Comparative Study Between Sevoflurane and Propofol.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: Propofol
Sevoflurane
Bispectral Index
Children
Electroencephalographic signs
Lead sponsor: Hôpital Armand Trousseau
Sponsor class: OTHER
Collaborators: name: Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau
First posted: 2016-09-09
Enrollment: 73
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: A cerebral pharmacodynamic feedback may help the anesthesiologist to adjust anesthetics administration. The BIS, which provides a single number resulting from an algorithm calculated from cortical EEG parameters, may play this role.Moreover, halogenated agents and propofol may have different EEG effects, which might interfere on measured BIS values.

The aim of this prospective randomized study was to compare, in steady state conditions, the EEG profiles in children anesthetized with sevoflurane (S) or propofol (P) : for both anesthetics, the BIS-concentration relationship and raw EEG were analysed at different levels of general anesthesia.

Detailed description: Children will be prospectively included and randomly assigned in two groups : Propofol (P) Group or Sevoflurane (S) Group.

Steady state periods will be performed at a fixed randomized concentration between 2, 3, 4, 5 and 6 mcg/ml of stable Ct P concentration in the P group and between 1,2,3,4,5 % of FeS in the S group.

At the end of each steady-state period the BIS value was noted and the relationship between BIS and anesthetic concentrations will be studied using non linear regression. For all steady state periods, EEG traces will be reviewed to determine the presence of epileptiform signs (ES) and spectral EEG signal analysis with fast Fourier transformation (FFT) will be performed.

Eligibility criteria: Inclusion Criteria:

* from five to eighteen year of age, ASA 1 or 2, scheduled for middle ear surgery

Exclusion Criteria:

* obesity (body mass index \> percentile 97); history of cardiac, pulmonary, or renal disease; known neurological or neuromuscular disorders; preoperative administration of medications known to interfere with the central nervous system

Primary outcomes:
measure: Bispectral profiles
timeFrame: The average value of BIS is calculated on the last minute of each ten minutes steady state period .
Secondary outcomes:
measure: Incidence of epileptiform EEG signs
timeFrame: Last minute of each ten minutes steady state period
measure: Spectral analysis of EEG signal
timeFrame: Last minute of each ten minutes steady state period
Other outcomes:
Locations:
city: Paris
country: France
facility: Departement d'anesthesie Hopital Armand Trousseau
Study officials:
References:
Clinical trial NCT01261104: Relationship Between Hearing Thresholds, Handicap and Time for Treatment-seeking
Official title: Relationship Between Hearing Thresholds, Handicap and Time for Treatment-seeking in a Public Hearing Healthcare Service
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Impairment
Keywords: hearing loss
handicap
counseling
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-12-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hearing impaired adults and elderly attended at a public hearing healthcare service

Brief summary: Purpose: to investigate the relationship between time for treatment seeking and audiometric data and self-assessment of handicap for patients in a public hearing healthcare service. Methods: Retrospective study. Records of 152 elderly and 48 adults with hearing impairment were analyzed. The ISO audiometric thresholds average (500 to 4000Hz) and high frequencies average (2000 to 6000Hz), the speech recognition thresholds and the total, social and emotional scores from the Hearing Handicap Inventory for the Adults (HHIA) and Elderly (HHIE) were compared with the time between the onset of hearing complaints and the first treatment seeking. Results: The average time for treatment seeking was 7,6 years. No statistical difference was found between ISO and high frequency audiometric average, HHIA/E scores and time for treatment seeking between adults and the elderly. Weak but significant negative correlations were observed between the audiometric data and time for treatment seeking. There was no relationship between the time for treatment seeking and educational, socioeconomic levels and perception of handicap. Conclusions: The search for treatment seems to be multifactorial. Despite technological advances and changes in access to information and treatment time for treatment seeking was similar to that reported 30 years ago.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years old. Without experience with hearing aid use. Diagnosed with sensorineural hearing loss. Audiogram data available

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: Faculdade de Odontologia de Bauru
state: Sao Paulo
Study officials:
affiliation: Faculdade de Odontologia de Bauru
name: Deborah Ferrari, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01068704: Efficacy and Safety of BMS-690514 in Combination With Letrozole to Treat Metastatic Breast Cancer
Official title: An Open-Label Randomized, Parallel, Two-Arm Phase II Study Comparing BMS-690514 + Letrozole With Lapatinib + Letrozole in Recurrent and Metastatic Breast Cancer Patients Who Are Hormone Receptor Positive Despite HER2 Status And Who Relapsed While Receiving or After Completing Adjuvant Antiendocrine Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-02-15
Enrollment: 4
Sex: FEMALE
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 determine if BMS-690514 + letrozole will be more effective than lapatinib + letrozole in patients who have metastatic hormone receptor positive breast cancer after developing progressive disease immediately following adjuvant antiendocrine therapy


Eligibility criteria: Inclusion Criteria:

* Documented invasive breast cancer
* Greater than 10% tumor cells positive for estrogen receptor and/or progesterone receptor
* HER2+ and HER2- (Human Epidermal growth factor Receptor) disease
* Rapid disease progression despite treatment with tamoxifen, anastrozole or exemestane
* ECOG Performance status = 0 or 1

Exclusion Criteria:

* Prior hormonal therapy for metastatic disease
* Prior hormonal therapy with letrozole for adjuvant disease
* Symptomatic brain metastases
* Prior treatment with any tyrosine kinase inhibitor

Primary outcomes:
measure: Clinical Benefit Rate defined as percentage of subjects with a complete response, partial response, or stable disease for at least 6 months
timeFrame: Every 8 weeks according to CT scan
Secondary outcomes:
measure: Progression Free Survival: defined as time to disease progression
timeFrame: Every 8 weeks
measure: Objective Response Rate: defined as percentage of subjects with 'complete response' or 'partial response'
timeFrame: Every 8 weeks
measure: Frequency and severity of adverse events in all subjects
timeFrame: Every 4 weeks
Other outcomes:
Locations:
city: Abilene
country: United States
facility: Texas Oncology-Abilene
state: Texas
city: Beaumont
country: United States
facility: Texas Oncology-Beaumont
state: Texas
city: Fort Worth
country: United States
facility: Us Oncology Central Pharmacy
state: Texas
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital/North Star Lodge
state: Washington
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: La Rioja
country: Argentina
facility: Local Institution
city: Colima
country: Mexico
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05794204: RMP-A03 Ocular Suspension in Patients With Pterygium
Official title: A Phase 2a Study Evaluating the Safety and Efficacy of RMP-A03 Ocular Suspension in Patients With Pterygium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pterygium
Lead sponsor: Suzhou Raymon Pharmaceuticals Company, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: WuXi Clinical
First posted: 2023-04-03
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized in a 1:1:1 fashion
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to test the safety and efficacy of an ocular medication on the treatment of pterygium.

Detailed description: Following informed consent, patients with pterygium who meet all eligibility criteria will be randomized to an 84-day double-blinded study to measure the safety and efficacy of the study drug as compared to placebo.

Eligibility criteria: Inclusion Criteria:

* Must be at least 18 years old
* Diagnosis of pterygium with specified characteristics
* BCVA of 20/200 or better
* Willingness to attend all study visits and comply with the study procedures

Exclusion Criteria:

* Presence of ocular disease
* Double pterygium
* History of ocular surgery
* Presence of ocular trauma
* Use of any ocular medication
* Use of contact lens
* Allergy to any of the components of study drug
* Cannot properly administer study drug
* Clinically significant systemic disease that may place the subject at risk or confound study results
* Participation in an investigational study within 30 days prior to screening
* Female participants who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control (WOCBP).

Primary outcomes:
measure: Change from baseline in pterygium hyperemia grading at Day 28
timeFrame: 28 days
Secondary outcomes:
measure: Change from baseline in pterygium characteristics at Day 28
timeFrame: 28 days
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Global Research Management
state: California
city: Inglewood
country: United States
facility: United Medical Research Institute
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation Inc
state: California
city: Miami
country: United States
facility: Oceane7 Medical & Research Center Inc.
state: Florida
city: Nashville
country: United States
facility: Toyos Clinic
state: Tennessee
city: Austin
country: United States
facility: Keystone Research
state: Texas
Study officials:
References:
Clinical trial NCT04451304: Autonomic Reflexes During Intra-arterial Chemotherapy for Retinoblastoma
Official title: Cardiorespiratory Autonomic Reflexes During Superselective Ophthalmic Artery Chemotherapy for Retinoblastoma in Children: a Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Retinoblastoma
Retinoblastoma Bilateral
Chemotherapy Effect
Keywords: Retinoblastoma
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 200
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing cancer treatment for unilateral or bilateral retinoblastoma at the Instituto de Oncologia Pediátrica da Universidade Federal de São Paulo - GRAACC, São Paulo - Brasil.

Brief summary: Prospective observational study in patients undergoing intra-arterial ophthalmic artery chemotherapy for the treatment of retinoblastoma. The main objective of the study is to evaluate the incidence of cardiorespiratory autonomic reflexes in these patients and to investigate the association between autonomic reflexes and perioperative clinical characteristics.


Eligibility criteria: Inclusion Criteria:

* All patients diagnosed with retinoblastoma and submitted to intra-arterial chemotherapy during the study period
* Informed consent form signed and dated by legal guardian and investigator
* Informed assent form signed by the patient if appropriate

Exclusion Criteria:

* Refusal of the patient or guardian to participate in the research project

Primary outcomes:
measure: Cardiorespiratory autonomic reflexes incidence
timeFrame: from the admission of the patient in the operating room until the end of the procedure (intra-arterial chemotherapy)
Secondary outcomes:
measure: Clinical background and autonomic reflexes occurence
timeFrame: from the admission of the patient in the operating room until the end of the procedure.
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Mariana F Lima, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04823104: Optimizing Access to Care During Pregnancy in Rural Areas in a Perinatal Health Network
Official title: Optimizing Access to Care During Pregnancy in Rural Areas in a Perinatal Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Living in an Isolated Area
Keywords: Pregnancy
Home visitation
Isolated geographic area
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 330
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Pregnant women who live in rural area have fewer prenatal consultations. It has been demonstrated that maternal and neonatal morbidity and mortality increase if time travel to a maternity ward is longer than 30 min.

Home visitation in isolated area may improve prenatal follow-up as it gives full access to women to health care professionals as well as biological and ultrasound exams without travelling.

Our aim is to assess the impact of home visitation on prenatal follow-up as compared to prenatal follow-up in maternity ward and in primary care.

Isolated areas will be randomized, for women living in areas included in the intervention group, home visitations will be planned for prenatal follow-up. Ultrasound screening as well as blood exams will be performed during home visitations. For women living in control areas, they will be free to choose prenatal follow-up modalities.


Eligibility criteria: Inclusion Criteria:

* At the first antenatal consultation, confirming the pregnancy.
* Pregnant women who live in an area of geographic vulnerability covered by a perinatal network
* The women must be informed about the study, understand, read, and speak French, and must be able to consent to participate in medical research

Exclusion Criteria:

* Pregnant women who live outside an area of geographic vulnerability covered by a perinatal network
* Women who give birth in a maternity ward outside Auvergne
* Women from another region giving birth in a maternity ward in Auvergne

Primary outcomes:
measure: adequate pregnancy follow-up according to the French recommendations
timeFrame: 9 months
measure: adequate pregnancy follow-up according to the French recommendations
timeFrame: 9 months
measure: adequate pregnancy follow-up according to the French recommendations
timeFrame: 9 months
Secondary outcomes:
measure: Adherence to antenatal care consultations of women
timeFrame: 9 months
measure: Adherence to antenatal care complementary exams of women by the mobile antenatal care clinic
timeFrame: 9 months
measure: adverse neonatal outcome
timeFrame: 9 months
measure: adverse maternal outcome
timeFrame: 10 months
measure: economic analyse of the intervention
timeFrame: 24 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
state: Aura
Study officials:
References:
Clinical trial NCT02436304: Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2
Official title: Safety and Efficacy of EXE844 Otic Suspension in the Treatment of Otitis Media at Time of Tympanostomy Tube Insertion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Otitis Media With Effusion in Children
Otitis Media Recurrent
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2015-05-06
Enrollment: 404
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).


Eligibility criteria: Inclusion Criteria:

* Recurrent acute otitis media (RAOM) or chronic otitis media with effusion (COME) and eligible for bilateral myringotomy and tympanostomy tube insertion.
* Suspected bacterial infection at time of surgery in at least 1 ear.
* Willing to refrain from water immersion of the ears following surgery without the use of adequate ear protection during swimming, bathing, showering and other water-related activities.
* Legally Authorized Representative (LAR) must read and sign the informed consent.
* Parent or caregiver must agree to comply with the requirements of the study and administer study medication as directed, complete required study visits, and comply with the protocol.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Previous otologic or otologic-related surgery within the past 30 days or ongoing complications.
* Middle ear pathology in either ear other than otitis media.
* Current acute otitis externa (AOE), malignant otitis externa (MOE) or other conditions which could interfere with evaluation of the study drug.
* Any systemic disease or disorder, complicating factor or structural abnormality that would negatively affect the conduct or outcome of the study based upon assessment by the Investigator.
* Known or suspected allergy or hypersensitivity to quinolones or other active or inactive ingredients present in the medications to be used in the study.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Subjects With Sustained Clinical Cure at Day 8
timeFrame: Day 8
Secondary outcomes:
measure: Percentage of Subjects With Microbiological Success at Day 14
timeFrame: Day 14
measure: Time to Cessation of Otorrhea
timeFrame: Up to Day 14
Other outcomes:
Locations:
Study officials:
affiliation: Alcon, A Novartis Division
name: Clinical Manager, Ophtha-GCRA
role: STUDY_DIRECTOR
References: