louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03487588: An A Study Assessing Subject Satisfaction With A-101 Topical Solution for Seborrheic Keratoses
Official title: An Open-Label Study Assessing Subject Satisfaction With A-101 Hydrogen Peroxide Topical Solution, 40% (w/w) Treatment for Seborrheic Keratoses of the Face, Neck, and Decolletage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seborrheic Keratosis
Lead sponsor: Aclaris Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-04
Enrollment: 41
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an open-label study designed to evaluate subject's satisfaction after treatment of seborrheic keratoses with A-101 40%.


Eligibility criteria: Inclusion Criteria:

1. Subject can comprehend and is willing to sign an informed consent for participation in this study.
2. Male or female between the ages of 30 and 75 years old.
3. Subject has 3 eligible Seborrheic Keratoses; 2 target SKs must be on the face, and the additional 1 target SK must be on the neck or decolletage.
4. Subjects must have had cryosurgery for SK removal within the last 6 months and prior to first treatment with A-101 Topical Solution.
5. Target and non-target SKs must not have been previously treated.
6. Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair the evaluation of any target or non-target SK or which exposes the subject to an unacceptable risk by study participation

Exclusion Criteria:

1. Subject has clinically atypical and /or rapidly growing Seborrheic Keratoses.
2. Subject has current systemic malignancy.
3. Subject would require the use of any topical treatment (e.g., moisturizers, sunscreens) to any of the target or non-target SKs 12 hours prior to any study visit.
4. Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage), or condition (e.g., sunburn, excessive hair, open wounds) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations

Primary outcomes:
measure: Subject Satisfaction
timeFrame: Day 113
Secondary outcomes:
measure: Effectiveness of Treatment
timeFrame: Day 113
measure: Comparison of Physician Lesion Assessment Score (PLA) to Subject Satisfaction
timeFrame: Day 113
Other outcomes:
Locations:
city: Fort Washington
country: United States
facility: Aclaris Investigational Site
state: Pennsylvania
city: Knoxville
country: United States
facility: Aclaris Investigational Site
state: Tennessee
city: Austin
country: United States
facility: Aclaris Investigational Site
state: Texas
Study officials:
affiliation: Aclaris Therapeutics
name: David Gordon, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02862288: Preliminary Study of Microwave Tumoral Ablation Performances for the Treatment of Pulmonary, Renal and Bone Neoplasia.
Official title: Preliminary Study of Microwave Tumoral Ablation Performances for the Treatment of Pulmonary, Renal and Bone Neoplasia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Lung Tumor
Bone Tumor
Renal Tumor
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of this work were to assess the feasibility, efficacy, short-term outcome and safety of microwave ablation in the treatment of malignant bone, lung and renal tumors.


Eligibility criteria: Inclusion Criteria:

* Men and women \> 18 years old
* Thermoablation indication of renal neoplasia, bone or lung decided during a multidisciplinary consultation meeting - Generally speaking, the indications are: (i) inoperable primary malignant tumor or secondary malignant tumor, (ii) resectable primary malignant renal and lung tumor with medical contraindication to surgery or general anesthesia
* Signature of informed consent for participation
* Affiliation to a social security scheme or French beneficiary of such a regime.

Exclusion Criteria:

* Contraindication to percutaneous thermoablation
* Renal or lung tumor up to 4 cm
* Women of childbearing age, premenopausal, non-sterilized surgically, and unwilling to use effective contraception
* Legal incapacity or legal capacity limited
* Person unlikely to cooperate in the study and / or low degree of cooperation expected by the investigator
* Person without health insurance
* Pregnant women

Primary outcomes:
measure: Tumor necrosis rate in post-intervention over one month monitoring period.
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
Study officials:
affiliation: Centre hospitalier régional universitaire de Besançon
name: Sébastien Aubry, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02756988: 18615 - Sun Protection Factor Assay
Official title: Sun Protection Factor (SPF) Assay UVA Protection Factor Assay (UVAPF) Minimal Persistent Pigment - Darkening Dose (MPPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-04-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form)
* Signed and dated Informed Consent Form
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01434888: Pharmacokinetics, Safety and Tolerability of the Preservative-free Fixed Dose Combination of Tafluprost 0.0015% and Timolol 0.5% Eye Drops
Official title: A Phase I, Randomized, Double-masked, 3-period Cross-over Clinical Study to Compare the Pharmacokinetics, Safety and Tolerability of the Preservative-free Fixed Dose Combination of Tafluprost 0.0015% and Timolol 0.5% Eye Drops to Those of Preservative-free Tafluprost 0.0015% and Timolol 0.5% Eye Drops in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: pharmacokinetics
Lead sponsor: Santen Oy
Sponsor class: INDUSTRY
First posted: 2011-09-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this study is to investigate the pharmacokinetics, safety and tolerability of the preservative-free fixed-dose combination of tafluprost 0.0015% and timolol 0.5% (FDC) to those of preservative-free tafluprost 0.0015% and timolol 0.5% eye drops in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Aged 18 to 45 years
* Good general health
* Meet best corrected ETDRS visual acuity

Exclusion Criteria:

* Significant systemic or ocular disease
* History of eye surgery, including refractive surgery
* Allergy or hypersensitivity to study drug
* Low heart rate (\<50 bpm)
* Clinically relevant low blood pressure
* Asthma
* Bradycardia
* Use of contact lenses within one week prior to screening or during the study
* Clinically significant obesity (body mass index \> 30 kg/m2)
* Blood donation within 2 months prior to screening
* Females who are pregnant or lactating and females not using adequate contraceptives

Primary outcomes:
measure: Pharmacokinetics after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops.
timeFrame: There are 3 cross-over treatment periods, plasma concentrations will be measured on Day 1 and Day 7
Secondary outcomes:
measure: Safety and tolerability after single and repeated administration of preservative-free FDC, tafluprost and timolol eye drops.
timeFrame: Day 1 and Day 7 of treatment periods I, II and III.
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital Eye Clinic
Study officials:
References:
Clinical trial NCT02656888: Efficacy and Safety of Irlanda-1-Association on the Treatment of Common Cold in Children
Official title: Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial to Evaluate the Efficacy and Safety of Irlanda-1-Association on the Treatment of Common Cold in Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Common Cold
Lead sponsor: EMS
Sponsor class: INDUSTRY
First posted: 2016-01-15
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
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 the clinical efficacy of the drug associations in the treatment of common cold symptoms.

Detailed description: Double-blind,randomized, multicenter; Maximal experiment duration: 7 days; 03 visits; Safety and efficacy evaluation.

Eligibility criteria: Inclusion Criteria:

* Participant within 48 hours of the onset of common cold symptoms: headache, sneezing, sore throat, nasal obstruction, cough, coryza and body pain;
* Signed Consent of the patient;
* Participant whose tutors have the capacity to understand and consent to the child's participation in the clinical study, manifested by signing TCLE

Exclusion Criteria:

* Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study;
* Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial;
* Patients with history of hypersensitivity to any of the formula compounds;
* Participation in clinical trial in the year prior to this study;
* Patients with vaccine reaction;
* Patients who have uncontrolled asthma however, participants in use of pulmonary corticosteroids (alone or in combination with other products) will be allowed if they are in stable dose and diagnosed with controlled asthma;
* Patients with gastroesophageal reflux, gastric or duodenal ulcer or other serious disease of the gastrointestinal tract;
* Patients with diabetes mellitus type I and II;
* Pregnancy or risk of pregnancy and lactating patients;
* Patients who were in use of drugs that can interfere with flu symptoms evaluation.

Primary outcomes:
measure: Determine the efficacy of Irlanda_1 association in the treatment of common cold symptoms.
timeFrame: 7 days
Secondary outcomes:
measure: Safety will be evaluated by the adverse events occurrences
timeFrame: 7 days
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Allergisa
state: São Paulo
Study officials:
References:
Clinical trial NCT02699788: Emergency Department MCG for Suspected Acute Coronary Syndrome
Official title: Emergency Department MCG for Suspected Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Coronary Syndrome
Lead sponsor: Tampa General Hospital
Sponsor class: OTHER
First posted: 2016-03-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to assess a new non-invasive computerized, multiphase, resting electrocardiogram analysis device in early identification of patients at risk for acute coronary syndrome. The overall objective is to assess the association between the results from a resting MCG and 30-day cardiovascular outcome in patients presenting to the emergency department with suspected coronary disease.


Eligibility criteria: Inclusion Criteria:

* Age 18 and over.
* Symptoms consistent with a possible acute coronary syndrome per the treating emergency physician.
* Has an electrocardiogram performed while in the ED.

Exclusion Criteria:

* Acute ST-segment elevation MI.
* Patient unable or unwilling to complete follow-up.

Primary outcomes:
measure: Accuracy of MCG as assessed by the development of major adverse cardiac events (MACE).
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
Study officials:
affiliation: Tampa General Hospital
name: Jason Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04740788: Study on Visual Performance of a Monofocal Intraocular Lens
Official title: Multicentric Retrospective/Prospective Study on Visual Performance of a Monofocal Intraocular Lens (IOL)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract Senile
Lead sponsor: Carl Zeiss Meditec AG
Sponsor class: INDUSTRY
First posted: 2021-02-05
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cataract patients already implanted with a monofocal IOL

Brief summary: Retrospective/Prospective Study on Visual Performance of a Monofocal Intraocular Lens (IOL). The objective is to compare best corrected distance visual acuity (CDVA) between 1-3-month and 12- month follow-up.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older;
* Patients with monolateral or bilateral (only one eye will be the study eye) monofocal IOL implantation after uncomplicated surgery in the period between May 2019 and November 2019, if the follow-up visit can be performed 10-18 months after surgery;
* No visual acuity limiting pathologies;
* Availability of 1-3-month postoperative data
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures in case of a prospective 12-month visit;
* Written informed consent for participation in the study and data protection.

Exclusion Criteria:

* Difficulty for cooperation (distance from their home, general health conditions)
* Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that would confound visual acuity measurements;
* Subjects with surgical complications or secondary interventions (except for Nd:YAG capsulotomy) related to the cataract surgery of the monofocal IOL eye(s) or any other interventions in the post-operative eye including but not limited to glaucoma surgery, retinal surgery;
* Visual field loss which has impact on visual acuity;
* Use of systemic or ocular medication that might affect vision;
* Patients with amblyopia, strabismus, forme fruste keratoconus or keratoconus;
* Capsular or zonular abnormalities that have affected postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome);
* Concurrent participation in another device investigation.

Primary outcomes:
measure: Best corrected distance visual acuity (CDVA)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Borkenstein & Borkenstein
Study officials:
References:
Clinical trial NCT04989088: Neurofeedback Training for Dyslexia
Official title: Neurofeedback Training to Restore Hemispheric Imbalance in Dyslexia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dyslexia
Reading Problem
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
Collaborators: name: University of Milan
First posted: 2021-08-04
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims at testing a Neurofeedback (NF) training specifically designed for inducing a functional hemispheric imbalance of the tempo-parietal regions in individuals with dyslexia. A randomized clinical trial aimed at comparing two experimental conditions is described: a) Left theta/beta NF training in combination with right beta/theta NF training and b) sham NF training.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of dyslexia or reading performance 2 SD below the norm
* Average intelligence

Exclusion Criteria:

* Psychiatric conditions
* Comorbidity with neurodevelopmental disorders
* Neurological disorders
* Epilepsy
* Enrollment in linguistic or literature university courses

Primary outcomes:
measure: EEG recording - ProComp5 Infiniti System
timeFrame: 1 hour
measure: Phonological task (Spironelli & Angrilli, 2006) accuracy
timeFrame: 1 hour
measure: Phonological task (Spironelli & Angrilli, 2006) speed
timeFrame: 1 hour
measure: Semantic task (Spironelli & Angrilli, 2006) speed
timeFrame: 1 hour
measure: Semantic task (Spironelli & Angrilli, 2006) accuracy
timeFrame: 1 hour
measure: Text reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
timeFrame: 1 hour
measure: Text reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
timeFrame: 1 hour
measure: Word reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
timeFrame: 1 hour
measure: Word reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
timeFrame: 1 hour
measure: Psuedo-word reading speed - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
timeFrame: 1 hour
measure: Psuedo-word reading accuracy - LSC-SUA Battery (Cornoldi, Montesano & Valenti, 2020)
timeFrame: 1 hour
Secondary outcomes:
measure: Rapid automatized naming speed (RAN, De Luca, Di Filippo, Judica, Spinelli & Zoccolotti, 2005)
timeFrame: 1 hour
measure: Rapid automatized naming accuracy (RAN, De Luca, Di Filippo, Judica, Spinelli & Zoccolotti, 2005)
timeFrame: 1 hour
measure: Digit Span (Wechsler Adult Intelligence Scale - Fourth Edition, WAIS-IV)
timeFrame: 1 hour
Other outcomes:
Locations:
Study officials:
References:
citation: Cancer A, Vanutelli ME, Lucchiari C, Antonietti A. Using Neurofeedback to Restore Inter-Hemispheric Imbalance: A Study Protocol for Adults With Dyslexia. Front Psychol. 2021 Nov 5;12:768061. doi: 10.3389/fpsyg.2021.768061. eCollection 2021.
Clinical trial NCT01299688: HER2 Circulating Tumor Cells in Gastric Cancer
Official title: HER2 Circulating Tumor Cells in Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-02-18
Enrollment: 135
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: metastatic gastric cancer

Brief summary: The investigators propose to survey the frequency of HER2 (+) CTC in order to lay groundwork for future clinical trials incorporating Her-2 targeted agents in gastric cancer.

Detailed description: We propose to survey the frequency of HER2 (+) CTC in order to lay groundwork for future clinical trials incorporating Her-2 targeted agents in gastric cancer. Blood samples will be collected from metastatic gastric cancer patients.

Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years ② Patients with localized, histologically confirmed gastric cancer ③ Informed consent form

Exclusion Criteria:

* No informed consent form

Primary outcomes:
measure: To survey the frequency of HER2(+) CTC in gastric cancer
timeFrame: 24month
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Won Ki Kang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03132688: A Study on Safety and Efficacy of Propofol in Small Children Under 2 Years of Age
Official title: A Retrospective Study on Safety and Efficacy of Propofol in Small Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Rate Low
Anesthesia; Functional
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 100
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children who underwent surgery From September 2013 to December 2016 , and received intravenous propofol for general anesthesia will be enrolled.

Brief summary: This retrospective study the safety and efficacy of intravenous propofol used in children under 2 years of age during general anesthesia for surgery.

Detailed description: EMR review of intravenous propofol used in target controlled infusion method in children under 2 years old.

Eligibility criteria: Inclusion Criteria:

* Children under 2 years of age
* Children who received intravenous propofol for maintenance of anesthesia

Exclusion Criteria:

* Children who underwent general anesthesia with inhalational anesthetics

Primary outcomes:
measure: Safety: blood pressure
timeFrame: Intraoperative 1 day
measure: Safety: blood pressure
timeFrame: Intraoperative 7th days
Secondary outcomes:
measure: Bispectral index
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUH
state: Jongro Gu
Study officials:
affiliation: Seoul National University Hospital
name: Hee-Soo Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References: