louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01296282: Comparison Between Internal and External Chest Impedance Measurement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-02-15
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with heart failure with CRT pacemaker

Brief summary: To compare two methods of chest impedance: the Medtronics Optivol Measurement via CRT pacemakers for patients with heart failure and external non-invasive measurement


Eligibility criteria: Inclusion Criteria:

* CRT-implanted patients with heart failure

Exclusion Criteria:

* All others

Primary outcomes:
measure: External measurement of chest impedance can be effective in monitoring heart failure patients
timeFrame: Three years
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT01521182: Effect of the Consumption of a Fermented Dairy Drink on the Immune Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Free-living Elderly
Keywords: Probiotic - dairy product - influenza vaccination - healthy elderly
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2012-01-30
Enrollment: 550
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether the regular consumption of the active product enhances the immune function, in comparison to the control product.


Eligibility criteria: Inclusion Criteria:

* Healthy free-living both gender elderly aged from 65 to 80 years old on the day of inclusion
* Able to comply with all the trial procedures
* Having given written consent to take part in the study prior to participation.
* Body mass index (BMI): 18,5 \< BMI \< 30 kg/m².

Exclusion Criteria:

* Contra-indication to any of the products and procedures used for the study purpose
* Participation in another clinical trial
* People currently institutionalised
* Immunocompromised conditions or other conditions that may impact the immune response or the product effect
* Subjects suffering from a not stabilized chronic disease
* Subjects suffering from a sever acute or chronic disease
* Subjects suffering from a condition which is at a stage where it might prevent him/her from being able or willing to comply with the study procedures or completion
* Subject known to be deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
* Subject identified as employees of the Investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that Investigator or study centre, as well as family members (i.e., immediate, husband, wife and their children, adopted or natural) of the centre's employees or the Investigator.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wilrijk - Antwerp
country: Belgium
facility: Faculty of Medicine, Centre for the Evaluation of Vaccination, Vaccine & Infectious Disease Institute - University of Antwerp
Study officials:
References:
Clinical trial NCT05733182: Effect of Colour Temperature of Reading Lamp on Refractive Error Development
Official title: Effect of Colour Temperature of Reading Lamp on Refractive Error Development
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Refractive Errors
Keywords: Myopia
Environment
Colour temperature
Lighting
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 798
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a 12-month longitudinal randomized controlled trial aiming to evaluate the effect of colour temperature of reading lamp on refractive error development.

Detailed description: Myopia has reached epidemic in the world, especially in East Asia. The proportion of myopic population increases drastically during schoolage. Lack of light exposure has been suggested to be a risk for myopia development, in which additional reading lamp may alleviate this condition. However, the effect of colour temperature of the reading lamp is unknown on childhood refractive error development. In this study, investigators will randomly allocate school-aged children into groups, who will receive reading lamps of different colour temperatures for their daily use. The participants' refractive error and axial length will be evaluated.

Eligibility criteria: Inclusion Criteria:

* aged between 4 and 18 years

Exclusion Criteria:

* have received myopia control intervention

Primary outcomes:
measure: Cycloplegic refraction
timeFrame: up to 12 months
measure: Axial length
timeFrame: up to 12 months
Secondary outcomes:
measure: Colour vision
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Optometry Research Clinic
state: Kowloon
Study officials:
References:
Clinical trial NCT05094882: Anatomical Location and Metastasis Pattern of Intrapulmonary Lymph Nodes in NSCLC (ECTOP-1010)
Official title: Anatomical Location and Metastasis Pattern of Intrapulmonary Lymph Nodes in Non-small Cell Lung Cancer: a Multi-center, Prospective Observational Clinical Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carcinoma
Non-small Cell Lung Cancer
Keywords: Non-small Cell Lung Cancer
Intrapulmonary Lymph Nodes
Anatomical Location
Metastasis Pattern
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with stage T1 peripheral non-small cell lung cancer (NSCLC) undergoing radical lobectomy

Brief summary: This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1010. Anatomical Location and Metastasis Pattern of Intrapulmonary Lymph Nodes (Group 11-13) in Non-small Cell Lung Cancer: a Multi-center, Prospective observational Clinical Trial

Detailed description: Patients would be evaluated whether meet the criteria as clinical stage T1 non-small Cell Lung Cancer. Then, he/she would receive lobectomy. Finally, the detailed anatomical location of group 11-13 would be recorded immediately after surgery and their metastasis pattern would be explored in the follow-up period.

Eligibility criteria: Inclusion Criteria:

1. Preoperative examination showed patients with clinical T1 peripheral non-small cell lung cancer (NSCLC);
2. The lesion is located in a single lung segment or between two adjacent lung segments;
3. Perform radical lobectomy;
4. The preoperative examination did not reveal unresectable lymph nodes;
5. Have not received any other tumor-related treatments (including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) before surgery;
6. No malignant tumor history;
7. No contraindications to surgery (ECOG score 0-1 points);

Exclusion Criteria:

1. Pathology revealed patients with non-T1 stage non-small cell lung cancer (NSCLC);
2. Radical lobectomy is not performed;
3. Acception of any anti-tumor treatment before surgery (excluding Chinese medicine treatment);
4. Refused to enter the group or asked to leave the group.

Primary outcomes:
measure: metastasis rate of group 11-13 LN
timeFrame: one month after surgery
Secondary outcomes:
measure: detailed anatomical location
timeFrame: immediately after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University Affiliated Shanghai Cancer Center
name: Hong Hu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06535282: Brain Mechanism and Outcome of Surgical Intervention of Conductive Hearing Loss.
Official title: The Brain Network Mechanism and Outcome After Surgical Intervention of Conductive Hearing Loss Accompanied by Tinnitus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conductive Hearing Loss
Tinnitus
Surgery
Keywords: Conductive Hearing Loss
tinnitus
surgery
outcome
EEG
mechanism
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study explores the brain region activation and remodeling of poor connections of brain regions in the postoperative outcomes of conductive hearing loss patients with tinnitus by comparing pre - and post-operative audiological assessment, tinnitus assessment and EEG data.

Detailed description: This study explores the brain region activation and remodeling of poor connections of brain regions in the postoperative outcomes of conductive hearing loss patients with tinnitus by comparing pre - and post-operative audiological assessment, tinnitus assessment and EEG data. Including audiological assessment (pure tone audiometry, speech test), tinnitus assessment (tinnitus matching, tinnitus handicap inventory, tinnitus function index, visual analogue scale)and non-invasive brain imaging assessment (EEG, fNIRS).

Eligibility criteria: Inclusion Criteria:

* aged between 18 and 60 years;
* diagnosed with conductive hearing loss with tinnitus;
* treated with surgery;
* able to cooperate with all Chinese version evaluation;
* right-handed.

Exclusion Criteria:

* Pure tone audiometry indicates that the average pure tone hearing threshold (500Hz, 1kHz, 2kHz, 4kHz) is \> 91dB HL;
* acoustic neuroma, nasopharyngeal carcinoma;
* hearing loss caused by noise or drugs.

Primary outcomes:
measure: pure tone audiometry
timeFrame: 3-7 days before surgery, 1-12 months after surgery
measure: speech test
timeFrame: 3-7 days before surgery, 1-12 months after surgery
measure: EEG activation
timeFrame: 3-7 days before surgery, 1-12 months after surgery
measure: tinnitus handicap inventory scores
timeFrame: 3-7 days before surgery, 1-12 months after surgery
Secondary outcomes:
measure: tinnitus function index scores
timeFrame: 3-7 days before surgery, 1-12 months after surgery
measure: visual analogue scale
timeFrame: 3-7 days before surgery, 1-12 months after surgery
measure: fNIRS activation
timeFrame: 3-7 days before surgery, 1-12 months after surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT05089682: Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep
Official title: Morpheus - Manipulating and Optimizing Brain Rhythms for Enhancement of Sleep
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neurological Disease
Parkinson Disease
Epilepsy
Keywords: Deep Brain Stimulation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate whether researchers can improve sleep quality in patients with deep brain stimulators by delivering targeted stimulation patterns during specific stages of sleep.


Eligibility criteria: Inclusion Criteria:

* DBS in one of the defined nuclei of interest during the period of the study
* Be willing and able to give written and oral informed consent
* Ability to complete all required study procedures including travelling to Mayo Clinic and staying overnight
* All women of childbearing potential and women who have been amenorrheic for less than 1 year must practice effective contraception during the study. This includes a barrier method such as condom or diaphragm with spermicide; barrier intrauterine device (IUD) or abstinence.

Exclusion Criteria:

* Cognitive impairment (judged by the clinician taking consent as not having sufficient mental capacity to understand the study and its requirements). This is including anyone who, in the opinion of the clinician taking consent is unlikely to retain sufficient mental capacity for the duration of their involvement in the study.
* Patients with any other medical condition that would interfere with study conduct or make it unsafe for them to participate
* Pregnancy test positive.

Primary outcomes:
measure: Participants to Complete Study
timeFrame: Through study completion, approximately 1 year
Secondary outcomes:
measure: Total Sleep Time
timeFrame: Baseline, post-intervention (approximately 1 night)
measure: Psychomotor Vigilance Test
timeFrame: Baseline, post-intervention (approximately 1 night)
measure: Karolinska Sleepiness Scale
timeFrame: Baseline, post-intervention (approximately 1 night)
measure: Latency to Sleep Onset
timeFrame: Baseline, post-intervention (approximately 1 night)
measure: Latency to Rapid Eye Movement (REM) Sleep
timeFrame: Baseline, post-intervention (approximately 1 night)
measure: Number of Sleep Cycles
timeFrame: Baseline, post-intervention (approximately 1 night)
measure: Number of Awakenings Per Night
timeFrame: Baseline, post-intervention (approximately 1 night)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Gregory Worrell, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01918982: Circulating Endothelial Progenitor Cells and Aortic Aneurysm
Official title: Interest of Circulating Endothelial Progenitor Cells CD34+144+CD14- and CD34+VEGF-R2+CD14- in the Follow-up of Aortic Aneurysm
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: - Aortic Aneurysm
Keywords: Aortic aneurysm
circulating endothelial progenitor cells
Lead sponsor: Hopital Jean Minjoz
Sponsor class: OTHER
First posted: 2013-08-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with aortic aneurysm

Brief summary: We aimed to see if aortic aneurysms could be followed-up by circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood level.

Detailed description: Circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- have been shown to be inversely correlated to aortic aneurysm size. We aimed to see if aortic aneurysms could be followed-up by circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood level. 40 patients followed for known aortic aneurysm \>30mm and \<50mm will be followed up every 6 months during 2 years. Each 6 months they will have a consultation by their physiologist with an echo or a CT-scan. At the same time, a 10ML blood sample will be taken to assess the circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood level.

Eligibility criteria: Inclusion Criteria:

* Aortic aneurysm size \>30mm and \> 50mm

Exclusion Criteria:

* Infectious disease
* Inflammatory disease
* Liver insuffisency
* Cancer evolutive
* Pregnant women

Primary outcomes:
measure: Circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- blood concentration
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Université de Franche-comté. France
name: Sidney Chocron, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Franche-Comté. France
name: Andrea Perrotti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Franche-Comté. France
name: Simon Rinckenbach, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Franche-Comté. France
name: Siamak Davani, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parietti E, Pallandre JR, Deschaseaux F, Aupecle B, Durst C, Kantelip JP, Chocron S, Davani S. Presence of circulating endothelial progenitor cells and levels of stromal-derived factor-1alpha are associated with ascending aorta aneurysm size. Eur J Cardiothorac Surg. 2011 Jul;40(1):e6-12. doi: 10.1016/j.ejcts.2011.02.065. Epub 2011 Apr 9.
Clinical trial NCT00764582: Ocular Penetration of 1.5% Levofloxacin and 0.5% Moxifloxacin During Corneal Transplant Surgery
Official title: A Randomized, Observer-masked, Parallel-group, Multicenter Trial Evaluating the Ocular Penetration of 1.5% Levofloxacin Ophthalmic Solution and 0.5% Moxifloxacin Ophthalmic Solution in Subjects Undergoing Corneal Transplant Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Corneal Transplantation
Keywords: Corneal penetration of levofloxacin and moxifloxacin
Lead sponsor: Santen Inc.
Sponsor class: INDUSTRY
Collaborators: name: Vistakon Pharmaceuticals
First posted: 2008-10-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Compare the corneal penetration of levofloxacin 1.5% and moxifloxacin 0.5% in patients undergoing penetrating keratoplasty (PK)


Eligibility criteria: Inclusion Criteria

* Man or woman 18 years of age or older
* Scheduled for corneal transplant surgery
* Patients must be healthy enough to undergo surgery
* Women must be postmenopausal for at least 1 year or surgically sterile incapable of pregnancy
* Women must be abstinent at the discretion of the investigator
* Women practicing an effective method of birth control
* Women agree before entry to continue to use the same method of contraception throughout the study
* Women of childbearing potential must have a negative urine pregnancy test at screening

Exclusion Criteria

* Presence of an active ocular infection or positive history of ocular herpetic infection
* History of severe dry eye syndrome
* Use of contact lenses in the 2 weeks prior to the study and for the duration of the study
* Received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment
* Pregnant or breast feeding
* Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center as well as family members of the employees or the investigator

Primary outcomes:
measure: Concentration of levofloxacin and moxifloxacin in the corneal tissue
timeFrame: Time of surgery
Secondary outcomes:
measure: Adverse Events
timeFrame: 4 days
Other outcomes:
Locations:
city: Boynton Beach
country: United States
state: Florida
city: Indianapolis
country: United States
state: Indiana
city: Great Rapids
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: Springfield
country: United States
state: Missouri
city: Stony Brook
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
Study officials:
References:
Clinical trial NCT01010282: Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-11-10
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study will evaluate the safety, efficacy, and acceptability of two artificial tears compared to a currently available artificial tear in subjects with dry eye.


Eligibility criteria: Inclusion Criteria:

* Current use of an artificial tear at least twice daily, for at least three months prior to Day 1, on average
* Ability/agreement to wear habitual correction (glasses) during study period

Exclusion Criteria:

* Known allergy or sensitivity to the study product(s) or its components
* Anticipate contact lens wear during the study, or subject has worn contact lenses in the last six months
* Chronic use of systemic medications which may affect a dry eye condition
* Active ocular allergy or infection
* Use of Restasis® or other topical cyclosporine products within 3 months prior to Day 1
* Current use of any topical ophthalmic medications, have used within 2 weeks prior to Day 1, or are likely to use during study.

Primary outcomes:
measure: Change From Baseline in Subjective Evaluation of Symptom of Dryness (SESoD)Score at Day 90
timeFrame: Baseline (Day 1), Day 90
Secondary outcomes:
measure: Change From Baseline in the Ocular Surface Disease Index (OSDI) Total Score at Day 90
timeFrame: Baseline (Day 1), Day 90
measure: Change From Baseline in Tear Break-up Time (TBUT) at Day 90
timeFrame: Baseline (Day 1), Day 90
measure: Change From Baseline in Corneal Staining at Day 90
timeFrame: Baseline (Day 1), Day 90
measure: Change From Baseline in Conjunctival Staining Severity Score at Day 90
timeFrame: Baseline (Day 1), Day 90
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Simmons PA, Carlisle-Wilcox C, Chen R, Liu H, Vehige JG. Efficacy, safety, and acceptability of a lipid-based artificial tear formulation: a randomized, controlled, multicenter clinical trial. Clin Ther. 2015 Apr 1;37(4):858-68. doi: 10.1016/j.clinthera.2015.01.001. Epub 2015 Feb 4.