louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01981460: PhotoDynamic Therapy for Line Infection Prevention (PLIP): Pilot Study on Healthy Volunteers.
Official title: PhotoDynamic Therapy for Line Infection Prevention (PLIP): Pilot Study on Normal Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Light; Therapy, Complications
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We are evaluating the effect of methylene blue and visible light activation on the microbiome of the skin.

Detailed description: Antiseptics are routinely utilized to prevent infections of vascular catheters. We are evaluating the addition of methylene blue and light activation on skin to determine whether this inexpensive and non-toxic treatment can decrease skin pathogens and prevent blood stream infections of long-term vascular catheters. This is a pilot study of normal volunteers to determine the effect on the microbiome of the addition of methylene blue and light activation on antiseptic-treated skin.

Eligibility criteria: Inclusion Criteria:

* Normal individuals without skin problems

Exclusion Criteria:

* Smokers
* Diabetics
* Atopic dermatitis
* G-6-PD deficiency
* Eczema
* Other skin conditions
* Allergies to methylene blue or chlorhexadine

Primary outcomes:
measure: Evaluation of the skin microbiome after methylene blue treatment
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MGH
name: Jeanine Wiener-Kronish, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01110460: Prospective Study on Asthma Control
Official title: Cross-sectional and Prospective Observational Study Aimed to Assess the Prevalence of Uncontrolled and Partially Controlled Asthmatics in Italy and the Prevalence of Uncontrolled/Partially Controlled Patients Achieved Asthma Control After 12 Months
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
Collaborators: name: Medidata Solutions
First posted: 2010-04-26
Enrollment: 2875
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Asthmatic patients

Brief summary: Accordingly, the new update of the Global Initiative for Asthma (GINA) guidelines 2006 is based on the control of the disease and attempts to quantify and graduate the level of control by using a classification of asthmatic subjects into controlled,partly controlled and uncontrolled groups.

Achieving and maintaining optimal asthma control is a major goal of asthma management. Although the results of clinical trials advocate that asthma control can be reached in most patients, there is evidence that many subjects with asthma have poorly controlled disease and that there is a significant gap between the treatment goals and the current level of asthma control achieved in the general population.

The aim of this study is to assess the prevalence of uncontrolled and partly controlled asthma in Italy using a patient-based tool such as Asthma Control Test.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained
* Male or female patients with asthma diagnosis (at least 6 months)
* ability to understand and fill in questionaires

Exclusion Criteria:

* Patients included in a clinical trial within the last 12 weeks
* Patients with serious illnesses
* Pregnant women

Primary outcomes:
measure: Asthma control test score
timeFrame: 3 months
Secondary outcomes:
measure: EuroQoL test score
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Policlinico Umberto I Roma
name: Claudio Terzano
role: STUDY_DIRECTOR
References:
citation: Terzano C, Cremonesi G, Girbino G, Ingrassia E, Marsico S, Nicolini G, Allegra L; PRISMA (PRospectIve Study on asthMA control) Study Group. 1-year prospective real life monitoring of asthma control and quality of life in Italy. Respir Res. 2012 Dec 6;13(1):112. doi: 10.1186/1465-9921-13-112.
Clinical trial NCT01058460: HPV-cytology Testing Versus Cytology Testing for the Detection of High Grade CIN
Official title: A Randomized Controlled Trial Comparing Concomitant HPV-cytology Testing With Conventional Cytology Testing for the Detection of High Grade Cervical Intraepithelial Neoplasia in Primary Cervical Cancer Screening in Hong Kong
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
Cervical Intraepithelial Neoplasia
Keywords: Cervical Intraepithelial Neoplasia, Grade III
Cervical Intraepithelial Neoplasia, Grade II
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: The Family Planning Association of Hong Kong
First posted: 2010-01-28
Enrollment: 12000
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To compare the effects of conventional cytology testing with concommitant HPV-cytology testing for the detection of high grade cervical lesions in primary cervical cancer screening in Hong Kong

Hypotheses:

1. There is a significant difference in the number of CIN2+ cases detected between the cytology testing group and the cytology-HPV co-testing group at baseline.
2. Significantly more CIN2+ cases will be detected at the second round of screening among participants with normal cytology result in the control arm than those with normal cytology and negative HPV results in the intervention arm.


Eligibility criteria: Inclusion Criteria:

* Ethnic Chinese women aged 30 to 60 years who have completed a written consent
* Women who have not attended screening for the past 3 years or more will be given priority

Exclusion Criteria:

* Currently pregnant
* Without a cervix
* Congenital abnormalities of the lower genital tract
* Previous history of invasive cervical cancer
* Who has been followed-up or treated for an abnormal cytology result in the past 12 months
* Who are unable to provide consent

Primary outcomes:
measure: Histological CIN2, CIN3 and cervical carcinoma
timeFrame: At baseline and each subsequent follow-up
Secondary outcomes:
measure: Clearance of mild cervical abnormalities among HPV negative subjects
timeFrame: At baseline and 1-year after
Other outcomes:
Locations:
city: Hong Kong SAR
country: China
facility: Department of Obstetrics & Gynaecology, The University of Hong Kong
Study officials:
affiliation: Department of Obstetrics & Gynaecology, The University of Hong Kong
name: Hextan YS Ngan, MD, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06358560: Applied Clinical Neuroscience and Its Effect on Self-reported Stress and Other Physiological Markers
Official title: Applied Clinical Neuroscience and Its Effect on Self-reported Stress and Other Physiological Markers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stress
Lead sponsor: The Brain Health Clinics
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators will recruit the first 5-15 people that present to the clinic on their own for treatment for 'stress'.

Brief summary: The purpose of this study is to see if an applied clinical neuroscience (ACN) approach to the symptom of 'stress' has a measurable effect on an individual's self-reported stress level. Physiological markers will be measured and analyzed to potentially allow for greater insight and aid in setting up any future research on this topic. This is an independent research study.


Eligibility criteria: Inclusion Criteria:

* Must be 18 years of age or older.
* Must be presenting to the clinic for treatment for 'stress'.

Exclusion Criteria:

* Under 18 years of age
* No vulnerable populations (physical or mental disability, economically or educationally disadvantaged, pregnancy, minors, persons incarcerated).
* No participants that have an additional relationship beyond the doctor/patient relationship that exists by nature of a patient committing to treatment (a family member or clinic employee would be excluded from the study).

Primary outcomes:
measure: NIH Toolbox® Item Bank v3.0 - Perceived Stress (Ages 18+) - Fixed Form
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: The Brain Health Clinics
state: Tennessee
Study officials:
References:
Clinical trial NCT04853160: Drug Use Study of Febuxostat After Recent Changes in the Prescribing Information
Official title: Drug Utilization Study to Describe the Pattern of Febuxostat Use in Relationship to Allopurinol Following Addition of the Boxed Warning and Modification of the Indication Based on the Results of the CARES Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gout
Cardiovascular Diseases
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-04-21
Enrollment: 24046
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with gout initiating febuxostat therapy on or after 01 June 2016 will be observed.

Brief summary: The prescribing information provides information on medicines. This study will check the number of patients starting febuxostat and the number of febuxostat users with cardiovascular disease after changes to the prescribing information.

Detailed description: This is a descriptive, cross-sectional, non-interventional study of participants with gout. The study will evaluate the impact of the 2019 labeling changes (boxed warning and modified indication), based upon results of the cardiovascular safety of febuxostat and allopurinol in participants with gout and cardiovascular morbidities (CARES) trial, on febuxostat utilization.

The study will evaluate data from approximately 24046 participants. The data will be collected from optum clinformatics dataMart (CDM) including the medicare advantage administrative US claims database and the IQVIA pharmetrics plus claims database.

All participants will be enrolled in a single observational cohort. This trial will be conducted in the United States. The overall duration of this study is approximately 14 months.

Eligibility criteria: Inclusion Criteria:

1. Index fill date on or after 01 June 2016.
2. Having at least one diagnosis for gout (identified with diagnosis codes, International Classification of Diseases, clinical modification, ninth revision \[ICD-9-CM\]: 274.x or International Classification of Diseases, tenth revision \[ICD-10\]: M10.x) at any time in the participant's record.
3. Continuously enrolled for at least 12 months prior to index fill date.

Primary outcomes:
measure: Number of Participants Newly Initiating Febuxostat Therapy Versus Prevalent New Users
timeFrame: Up to 14 months
measure: Number of Participants With Established Cardiovascular Disease (CVD)
timeFrame: Up to 14 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Central Contact
state: Massachusetts
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01947660: Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery
Official title: Continuous Regional Anesthesia for Septic Limb Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteo Arthritis
Cellulitis
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2013-09-20
Enrollment: 260
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: This study aims to assess the safety of using continuous regional anesthesia for post-operative analgesia during septic limb orthopedic surgery.

The study hypothesis is that continuous regional anesthesia would not induce septic complication in the operated limb and could improve post-operative recovery.


Eligibility criteria: Inclusion Criteria:

* Osteo arthritis or cellulitis requiring surgical intervention
* anatomical possibility of regional anesthesia
* age \>18 ans
* written informed consent

Exclusion Criteria:

* loco-regional anesthesia impossibility (puncture zone infection, local anesthesics allergie, amiodarone or mexilétine treatment, neurologic deficit for exemple)
* patient under tutelle or curatelle
* pregnant or beast feeding woman

Primary outcomes:
measure: Septic complication in the operated limb
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Illkirch
country: France
facility: CCOM
state: Alsace
Study officials:
References:
Clinical trial NCT03913260: A Study of Different Injectable Formulations of LY3375880 in Healthy Participants
Official title: A Safety, Tolerability, and Pharmacokinetic Study of Different Solution Formulations of LY3375880 Using Investigational Injection Devices in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2019-04-12
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Part A is a crossover design. Part B is a parallel design.
Primary purpose: BASIC_SCIENCE

Brief summary: The main purposes of this study are: 1. To learn more about the safety and side effects of different formulations of LY3375880 and 2. To measure how much LY3375880 gets into the blood stream and how long it takes to get out of the body. The study will last about 85 days. Screening may occur up to 28 days prior to enrollment.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy males or females, as determined by medical history and physical examination
* Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive
* Females who are not of child-bearing potential
* Males who agree to use a reliable method of birth control during the study and for 120 days following the final administration of LY3375880
* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

* Have known allergies to LY3375880, related compounds or any components of the formulation, or history of significant atopy
* Have participated or are currently enrolled in clinical trials with LY3375880
* Have infections or evidence of infections
* Are pregnant, lactating or breast feeding

Primary outcomes:
measure: Visual Analog Scale (VAS) Pain Score
timeFrame: Part A: Within 1-minute post injection
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3375880
timeFrame: Part B: Predose through Day 85
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3375880
timeFrame: Part B: Predose through Day 85
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Clinical Research Inc
state: Florida
city: Dallas
country: United States
facility: Covance
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00898560: Effect of Repeat Administration of Eslicarbazepine Acetate on the Pharmacokinetics of a Combined Oral Contraceptive
Official title: Effect of Repeated Administration of Eslicarbazepine Acetate (BIA 2-093) 800mg Once-daily on the Pharmacokinetics of a Combined Oral Contraceptive in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Partial Epilepsy
Keywords: Partial
Epilepsy
Eslicarbazepine acetate
Combined oral contraceptive
Pharmacokinetics
Tolerability
Lead sponsor: Bial - Portela C S.A.
Sponsor class: INDUSTRY
First posted: 2009-05-12
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) 800 mg once-daily (QD) affects the pharmacokinetics and tolerability of the components of a combined oral contraceptive (ethinyloestradiol and levonorgestrel).


Eligibility criteria: Inclusion Criteria:

* Pre-menopausal female subjects
* Age 18-40 years, inclusive
* Body mass index (BMI) 19-30 kg/m2, inclusive
* Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG
* Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening
* Negative urine pregnancy test at screening and admission to each treatment period.
* Using one of the following methods of contraception: double barrier or intrauterine device

Exclusion Criteria:

* Subjects who have any contra-indication to the use of oral contraceptives
* History or presence of clinically relevant diseases, disorders or surgical history
* History of alcoholism or drug abuse
* Have used medicines within two weeks of admission to first period that may affect the safety or other study assessments, in the investigator's opinion

Primary outcomes:
measure: Cmax - Maximum Observed Plasma Concentration
timeFrame: 15-day
Secondary outcomes:
measure: AUC0-t - Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Sampling Time at Which Concentrations Were at or Above the Limit of Quantification
timeFrame: 15-day
measure: AUC0-∞ - Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity
timeFrame: 15-day
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Human Pharmacology Unit (UFH), Section of Clinical Research (SIC), Department of Research & Development (DID), BIAL - Portela & Cª, SA, S. Mamede do Coronado
Study officials:
affiliation: Bial Portela
name: Manuel Vaz-da-Silva
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02410460: Anesthetics in Rhytidoplasty - A Comparison Study
Official title: The Use of Propofol/Ketamine Anesthesia With Bispectral Monitoring (PKA-BIS) Versus Inhalational Anesthetics in Rhytidoplasty - A Prospective, Double-blinded, Randomized Comparison Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rhytidoplasty
Lead sponsor: Mercy Facial Plastic Surgery Center
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is a prospective, double-blind, randomized comparison study of different anesthesia methods in rhytidoplasty surgery. The study is designed to determine whether post-operative side-effect profiles in patients undergoing elective cosmetic facelift surgery can be decreased through the use of propofol/ketamine anesthesia with bispectral monitoring (PKA-BIS) rather than general anesthesia, without increasing intra-operative time, side-effect profiles, or patient recall. Approximately 30 subjects undergoing facelift surgery performed by the principal investigator will participate.

Detailed description: PKA-BIS arm receives the following medications:

clonidine 0.1-0.2mg glycopyrrolate 0.2mg propofol infusion titrated to BIS of 60-75 ketamine 50mg + additional ketamine not to exceed 200mg aggregate dosage throughout the case local anesthetic (lidocaine/marcaine mix)

General Anesthesia arm receives the following medications:

Pre-operatively:

Pepcid 20mg Scopolamine 1.5mg transdermal patch Versed 2mg Zofran 8mg Reglan 10mg Glycopyrrolate - dose determined by anesthesiologist

During the case, medication choices and dosing were dependent on the anesthesiologist - all general anesthesia cases received inhalational anesthetic (type of anesthetic also varied based on anesthesiologist's choice)

Eligibility criteria: Inclusion criteria:

* Female
* 18 years of age or older
* Undergoing elective rhytidoplasty

Exclusion criteria:

* Male
* Under 18 years old
* Pregnant or breastfeeding
* Medically unfit to undergo surgery
* Undergoing brow-lift in conjunction with rhytidoplasty (due to the inability to properly secure the BIS monitor as it would lie within the surgical field)

Primary outcomes:
measure: Pain (QOR-40/VAS)
timeFrame: 1 week
measure: Nausea/vomiting (QOR-40)
timeFrame: 24 hours
measure: Time to awakening
timeFrame: 4 hours
measure: Time to discharge
timeFrame: 4 hours
measure: Overall feeling of well-being (QOR-40/VAS)
timeFrame: 1 week
Secondary outcomes:
measure: Cost (reported as a mean)
timeFrame: 1 day
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Mercy Facial Plastic Surgery Center
state: Missouri
Study officials:
References:
citation: Jones KA, LaFerriere KA. Intravenous Anesthesia With Bispectral Index Monitoring vs Inhalational Anesthesia for Rhytidoplasty: A Randomized Clinical Trial. JAMA Facial Plast Surg. 2015 Jul-Aug;17(4):239-44. doi: 10.1001/jamafacial.2015.0222.