louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00784641: A Product Performance Evaluation of a Novel Contact Lens for Daily Disposable Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2008-11-04
Enrollment: 567
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Evaluation of the clinical performance of a novel Bausch \& Lomb daily disposable contact lens when compared to the currently marketed Bausch \& Lomb SofLens® daily disposable contact lenses and the currently marketed Johnson and Johnson 1-Day Acuvue Moist contact lenses when worn by adapted soft contact lens wearers on a daily disposable basis.


Eligibility criteria: Inclusion Criteria:

* Subjects with VA correctable to 0.3 logMAR (driving vision) or better in each eye.
* Subjects must have clear central corneas and be free of any anterior segment disorders.
* Subjects must be myopic and require lens correction in both eyes.

Exclusion Criteria:

* Subjects with any systemic disease affecting ocular health.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects wearing monovision, multifocal or toric contact lenses.
* Subjects with grade 2 or greater slit lamp findings.

Primary outcomes:
measure: Percentage of Participants With Favorable Responses for the Initial Lens Performance Survey
timeFrame: At dispensing
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Dr. James Ferrari
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Bev Barna
role: STUDY_DIRECTOR
References:
Clinical trial NCT00866541: Flow Proportional Pressure Support in Volunteers
Official title: Flow Proportional Pressure Support as a New Mode of Spontaneous Breathing Assist - Evaluation of Objective and Subjective Measured Data in Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: resistance
flow proportional pressure support
pressure support ventilation
volunteers
assistant breathing
breathing comfort and objective breathing data
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2009-03-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Flow proportional pressure support (FPPS) is a new mode of spontaneous breathing assistance. In patients with increased respiratory resistance the role of FPPS in comparison with the pressure support assist breathing mode is still unclear. In this study the investigators evaluate objective and subjective measured data in healthy volunteers with artificial increased resistance and FPPS breathing assistance.


Eligibility criteria: Inclusion Criteria:

* age over 18 years
* ASA I and II

Exclusion Criteria:

* refusal of written informed consent
* chronic respiratory or cardiac diseases

Primary outcomes:
measure: pressure support
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University Medical Center Freiburg
Study officials:
affiliation: University Medical Center Freiburg
name: Daniel Steinmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mols G, Vetter T, Haberthur C, Geiger K, Guttmann J. Breathing pattern and perception at different levels of volume assist and pressure support in volunteers. Crit Care Med. 2001 May;29(5):982-8. doi: 10.1097/00003246-200105000-00018.
citation: Mols G, von Ungern-Sternberg B, Rohr E, Haberthur C, Geiger K, Guttmann J. Respiratory comfort and breathing pattern during volume proportional assist ventilation and pressure support ventilation: a study on volunteers with artificially reduced compliance. Crit Care Med. 2000 Jun;28(6):1940-6. doi: 10.1097/00003246-200006000-00042.
citation: Mols G, Rohr E, Benzing A, Haberthur C, Geiger K, Guttmann J. Breathing pattern associated with respiratory comfort during automatic tube compensation and pressure support ventilation in normal subjects. Acta Anaesthesiol Scand. 2000 Mar;44(3):223-30. doi: 10.1034/j.1399-6576.2000.440302.x.
citation: Guttmann J, Bernhard H, Mols G, Benzing A, Hofmann P, Haberthur C, Zappe D, Fabry B, Geiger K. Respiratory comfort of automatic tube compensation and inspiratory pressure support in conscious humans. Intensive Care Med. 1997 Nov;23(11):1119-24. doi: 10.1007/s001340050467.
Clinical trial NCT02115841: Effect of Transcutaneous Nerve Stimulation on Primary Motor Cortex to Modulate Cortical Excitability and Hemodynamic Response During Implicit Motor Learning: A TMS and NIRS Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transcutaneous Nerve Stimulation
Keywords: Transcutaneous Nerve Stimulation
serial reaction time task
functional near infrared spectroscopy
transcranial magnetic stimulation
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2014-04-16
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Noninvasive brain stimulation was recently gradually be emphasized. The electrical current applied on scalp can effective modulate cortical excitability. Forms of Stimulation included transcranial direct current stimulation(tDCS) and transcranial alternating stimulation(tACS). tDCS had been proved the effect of cortical excitability modulation. The polarization effect of direct current stimulation can modulation specific brain area and enhance motor performance. tACS was still controversial about the effect on cortical excitability. Previous study show that the frequency dependent excitatory or inhibitory effect on cortex. The possible mechanism was to affect brain oscillation status by provided different frequency of stimulation. Transcutaneous nerve stimulation (TENS) was common used on management of chronic pain. Peripheral nerve stimulation can enhance pain or sensory evoked potential was noted. Effect of low frequency TENS on central nervous is unknown.


Eligibility criteria: Inclusion Criteria:

* Health Adult

Primary outcomes:
measure: Motor evoked potential
timeFrame: Baseline,0 minute,30 minutes,60 minutes.
measure: Intracortical inhibition & Intracortical facilitation
timeFrame: Baseline,0 minute,30 minutes,60 minutes.
measure: Blood oxygen dependent level
timeFrame: Baseline,in experiment,0 minute,30 minutes,60 minutes.
measure: Implicit sequential motor task performance
timeFrame: Baseline,in experiment,0 minute,30 minutes,60 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
References:
Clinical trial NCT06201741: A Study to Evaluate the Human Biodistribution and Dosimetry of the Radionuclide Labeled ZT-111 in Patients With Metastatic Prostate Cancer
Official title: A Study to Evaluate the Human Biodistribution and Dosimetry of the Radionuclide Labeled ZT-111 in Patients With Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Specific Membrane Antigen Positive Metastatic Prostate Cancer
Keywords: PSMA positive metastatic prostate cancer
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is to evaluate the safety, biodistribution, radiation dosimetry and tumor uptake of the \[131I\]/\[18F\]/\[68Ga\]ZT-111 in patients with PSMA positive metastatic prostate cancer.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 65 years old.
2. Histologically or cytologically confirmed prostate adenocarcinoma with documented history of ≥1 metastatic lesions indicated by imaging.
3. Informed consent must be obtained in writing from the subject, their legally authorized representative, or caregiver.
4. Willing and able to comply with all aspects of this study.

Exclusion Criteria:

1. Severe hepatic or renal impairment.
2. History of major surgery within the last month.
3. Participation in another concurrent clinical trial.

Primary outcomes:
measure: Dosimetry
timeFrame: About 24hours from time of injection
Secondary outcomes:
measure: Incidence and severity of adverse events
timeFrame: From administration of [131I]/[18F]/[68Ga]ZT-111 until 1 week after injection
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
Study officials:
References:
Clinical trial NCT05267041: Joint Thoracic Oncology Research Unit of LYon: Lung CancerS DatabaSE (ULYSSE)
Official title: Prospective Longitudinal Cohort Associated to Blood Collection, Pathological Samples Collection, and Radiological and Pathological Imaging Collection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Data collection
lung cancer
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One questionnaire between diagnostic annoucement and first line treatement One 6 months later One before second line treatment One 6 months later after second line treatment Optionnal Veinous Blood Sample (28 mL) between the diagnostic annoucement and the first line of treatment
Primary purpose: OTHER

Brief summary: Prospective longitudinal cohort associated to blood collection, pathological samples collection, and radiological and pathological imaging collection.


Eligibility criteria: Inclusion Criteria:

* Patient treated for a thoracic cancer in the Lyon University Hospital: non-small cell lung cancer, small cell lung cancer, mesothelioma...
* Diagnosis can be done:

  * By cytology or pathologic assessment
  * Or by multidisciplinary team meeting decision:

    * Irradiation without morpho-metabolic sampling
    * Treatment without sampling based on non-invasive molecular data

Exclusion Criteria:

- Refusal to participate

For optional blood sampling :

* \< 30 kg for blood collection
* No blood sampling schedule for care

Primary outcomes:
measure: Number of participants registered in the lung cancer database
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
References:
Clinical trial NCT00473941: Life After Cancer: Behavioral Treatment Study to Improve Quality of Life
Official title: Expressive Writing and Adjustment to Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colorectal cancer
colon cancer
rectal cancer
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2007-05-16
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the study is to find new ways to improve the quality of life of people who have been treated for colon or rectal cancer.

Detailed description: Individuals who take part in the study can expect:

Two Interviews:

* To be interviewed by our research staff over the phone. The interviews will include questions about your current quality of life and health.

Brief Writing in a Journal:

* To write for 15 minutes twice a week for two weeks about aspects of your life.

Eligibility criteria: Inclusion Criteria:

* Treated for stage I, II or III colon or rectal cancer in the past 5 years
* Completed surgical treatment
* Must be able to read and write in English

Exclusion Criteria:

* History of other cancers, with the exception of non-melanoma skin cancer

Primary outcomes:
measure: Depressive symptoms
timeFrame: 2-Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Stephen Lepore, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Graduate College, City University of New York
name: Tracey A Revenson, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00168441: A Study Evaluating Botulinum Toxin Type A in Subjects With Postherpetic Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postherpetic Neuralgia
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 117
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: 4-month study including a 30-day baseline phase


Eligibility criteria: Inclusion Criteria:

* Postherpetic neuralgia for more than 3 months after the healing of a herpes zoster skin rash.

Exclusion Criteria:

* Previous use of botulinum toxin of any serotype or immunization to any botulinum toxin serotype.

Primary outcomes:
measure: Pain score
Secondary outcomes:
measure: Various Quality of Life questionnaires
measure: Reduction in area of pain/allodynia
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02401841: Resolution of Neuro-muscular Block in Great Obese Patients: Neostigmine vs Sugammadex
Official title: Resolution of Neuro-muscular Block in Great Obese Patients: Neostigmine vs Sugammadex
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Resolution of Neuromuscular Blockade
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Great obese patients undergoing videolaparoscopic surgery

Brief summary: It is a observational prospective study. The aim of this study is to compare neostigmine vs sugammadex in the resolution of neuro-muscular blockade in great obese patients.


Eligibility criteria: Inclusion Criteria:

* Great obese
* Videolaparoscopic surgery

Exclusion Criteria:

* Age under 18
* No acceptation of informed consent
* New York Heart Association \> 2

Primary outcomes:
measure: Differences in neuro-muscular block resolution time between two groups
timeFrame: up to 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCC Ca' Granda - Ospedale Maggiore Policlinico
Study officials:
References:
Clinical trial NCT00150241: A Seven-Week Dose-Ranging Study of CP-526,555 Compared With Placebo and Zyban for Smoking Cessation
Official title: A Seven-Week Double-Blind, Placebo-Controlled, Randomized, Multicenter Study Evaluating the Safety and Efficacy of Three Doses of CP-526,555 ( 0.3 mg QD, 1 mg QD, and 1 mg BID ) in Comparison With Zyban in Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 625
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to measure the safety and efficacy of three doses of varenicline for smoking cessation.


Eligibility criteria: Inclusion Criteria:

* Subjects must have smoked on average of at least ten cigarettes per day during the past year
* Subjects must have no period of abstinence greater than three months in the past year

Exclusion Criteria:

* Subjects with any history of cardiovascular disease
* Myocardial infarction
* Significant arrhythmias
* Poorly controlled hypertension

Primary outcomes:
measure: The primary efficacy outcome is smoking abstinence for any continuous 4-week period (4-week CQR) during the study treatment phase.
Secondary outcomes:
measure: Fixed window 4-week CQR, Weeks 3-6, 4-7
measure: Continuous abstinence from Target Quit Date to Weeks 12, 24, and 52
measure: 7-day Point Prevalence of abstinence Week 52
measure: Number of cigarettes smoked per day
measure: Minnesota Nicotine Withdrawal Scale
measure: Smoking Effects Inventory
measure: Brief Questionnaire of Smoking Urge
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: Farmington
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Morgantown
country: United States
facility: Pfizer Investigational Site
state: West Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05075941: Evaluation of Vaccination Coverage and Determinants of Success of the COVID-19 Vaccination Program Among Populations in Very Precarious Situations
Official title: PREVAC: Evaluation of Vaccination Coverage and Determinants of Success of the COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: vaccination coverage
migrants
homeless
travelling community
Lead sponsor: Epicentre
Sponsor class: OTHER
Collaborators: name: Institut de Recherche en Santé Publique, France
name: Medecins Sans Frontieres, Netherlands
name: Médecins du Monde
name: CROIX ROUGE FRANCAISE
name: OBSERVATOIRE DU SAMU SOCIAL
name: INTERLOGEMENT 93
name: Agence Regionale de Sante d'Ile de France
First posted: 2021-10-13
Enrollment: 3811
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: migrants, homeless and travelling community

Brief summary: The main objective of the study is to assess the level of vaccination coverage (VC) against COVID-19 among migrants, homeless and travelling community, according to their living conditions and housing.

The secondary objectives are :

* to compare the estimated level of vaccination coverage in the different sites and strata (emergency shelters/hotels, camps, workers' hostels, on the street) with the estimated level in the general population of the same territory obtained from the French Health Insurance data (SIVAC).
* identify the obstacles and leverage of vaccination (i.e. mobile team) according to living conditions and habitat (socio-demographic factors, personal health history, vaccine adherence, local health policies, etc.).


Eligibility criteria: Inclusion Criteria:

* Adult (18 years and older)
* People considered as homeless (homeless, living in a camp or squat) or
* Living in adapted housing (migrant workers' hostel) or
* Housed in residences of the National System or
* Housed in a social residence such as a 115 hotel or a social housing centre
* Freely and voluntarily consenting to participate

Exclusion Criteria:

* Refusal to participate in the study (non-consent).
* Language barrier with no in-person or telephone translation available.
* Impossibility to give free and informed consent (comprehension barrier, cognitive and/or psychiatric and/or addictive disorders, external pressure from family and friends, persons under guardianship, etc.).

Primary outcomes:
measure: Vaccination coverage among COVID-19
timeFrame: one month
measure: Identify the most appropriate conditions for the use of vaccination against COVID-19
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Marseille
city: Paris
country: France
facility: Paris
Study officials:
affiliation: Epicentre
name: Elisabeth POULET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03280641: D-dimer In Patients With atRial Fibrillation rEceiving antiCoagulation Therapy
Official title: The Role of D-dimer in Patients With Atrial Fibrillation Receiving Anticoagulation Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Strokes Thrombotic
Lead sponsor: Wuhan Asia Heart Hospital
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 1194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Non-valvular atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy.

Brief summary: This is a sigle-center, prospective study to evaluate the role of D-Dimer testing in patients with atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy.

Detailed description: Patients with atrial fibrillation receiving Dabigatran or warfarin anticoagulation therapy was screened and signed to two group: Dabigatran group and Warfarin group. D-dimer test was analyzed before and 3 months after anticoagulation starting specificly. Patients were followed-up for at least 12 months,and clinical outcomes, including thrombotic events major bleeding events and all-cause deaths were recorded during follow-up period.

Eligibility criteria: Inclusion Criteria:

* Non-valvular atrial fibrillation
* Receiving oral anticoagulation therapy and have good compliance

Exclusion Criteria:

* Life expectancy less than 1 year
* Thrombosis or major bleeding history within 3 months
* Refusal to Participate

Primary outcomes:
measure: Cardiovascular events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: WAHH
state: Hubei
Study officials:
affiliation: Wuhan Asia Heart Hospital
name: Litao ZHANG, MD
role: PRINCIPAL_INVESTIGATOR
References: