louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04502771: Therapeutic Drug Monitoring of Antifungals in Intensive Care Units
Official title: Therapeutic Drug Monitoring of Antifungals in Patients From Intensive Care Units: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Unit Patients
Keywords: Fluconazole
Voriconazole
Posaconazole
Caspofungin
Therapeutic drug monitoring
Blood concentration
Under-dosing
Over-dosing
Intensive Care Unit
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-08-06
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received antifungals during their ICU stay and had a TDM

Brief summary: Antifungals under- and over-dosing are frequently deplored in patients treated with antifungals and receiving recommended doses, mostly in critically-ill patients. This situation is well-described for antifungals from the azoles class mostly in patients with liver dysfunction or having concomitant drugs that may interact with azoles. This situation is less-described using echinocandins, although recent studies reported caspofungin underdosing for critically-ill patients. Considering that antifungals under-dosing was demonstrated to be associated with an increase in mortality, it is of utmost importance to analyse the relevance of therapeutic drug monitoring (TDM) for patients admitted in intensive care units (ICU). This will help to identify which patients are the more prone to antifungal under or over-dosing. Indeed, antifungals under-dosing may favour the development of clinical resistance to antifungals and increase mortality, whereas over-dosing may result in adverse events that may lead to treatment discontinuation.


Eligibility criteria: Inclusion Criteria:

* Adult patients who received antifungals including fluconazole, voriconazole, posaconazole, or caspofungin, during their ICU stay and had a Therapeutic Drug Monitoring (TDM)

Exclusion Criteria:

* Patients without antifungal treatment
* Patients who received an antifungal combination
* Pediatric patients
* Patients who were not admitted in ICU
* Patients who did not have a TDM

Primary outcomes:
measure: Antifungal blood concentration of patients admitted in intensive care units
timeFrame: Day 5 after antifungal initiation
Secondary outcomes:
measure: Adverse event
timeFrame: Day 30 after antifungal initiation
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon, Croix-Rousse Hospital
Study officials:
References:
Clinical trial NCT02313571: Breakthrough Pain Computer Integrated Patient Controlled Epidural Analgesia
Official title: Incidence and Characteristics of Breakthrough Pain in Parturients Using Computer Integrated Patient Controlled Epidural Analgesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Epidural Analgesia
Pain
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2014-12-10
Enrollment: 350
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who had nulliparous requested for labour epidural analgesia

Brief summary: The computer-integrated patient controlled epidural analgesia (CIPCEA) system can automatically adjust the background infusion rate during combined spinal-epidural (CSE) analgesia based on the parturient's need as labour progresses. Analysis of parturients experiencing breakthrough pain may identify associated factors that can also be related to obstetric or foetal outcomes

Detailed description: Computer integrated patient controlled epidural analgesia (CIPCEA) is a novel epidural analgesic delivery system that is currently used in daily practice in KK Women's and Children's Hospital. It has enabled us to monitor the infusion pumps through wireless connection to a central monitoring system and hence, collect pump utilisation data electronically. The CIPCEA system is programmed to analyse the LA usage across the last hour and adjust the background infusion rate according to a preset algorithm.

Breakthrough pain is defined as maternal complaint of pain or pressure that required and was successfully treated with supplemental epidural medications. we investigated the potential factors associated with breakthrough pain in patients who receive CSE epidural analgesia with CIPCEA, with the aim of elucidating the important associated factors.

Eligibility criteria: Inclusion Criteria:

* Nulliparous women,
* requested for epidural analgesia

Exclusion Criteria:

* Multiparous women,
* unable to perform combined spinal epidural technique

Primary outcomes:
measure: Breakthrough Pain (Requiring unscheduled epidural supplementation by anaesthetists)
timeFrame: 1 day
Secondary outcomes:
measure: Caesarean Section (Rate of caesarean section)
timeFrame: 1 day
measure: Instrumental Delivery (Rate of instrumental delivery)
timeFrame: 1 day
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Ban L Sng, FANZCA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03323671: Preemptive Analgesia for Primary Dysmenorrhoea
Official title: Preemptive Analgesia for Primary Dysmenorrhoea: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Primary Dysmenorrhea
Keywords: primary dysmenorrhea
preemptive analgesia
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 84
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Preemptive analgesia before the release of pain mediators

Detailed description: spasmodic dysmenorrhea is one of the most distressing symptoms in women. adolescents shows a usual absence from school . prostaglandin release is one of the most accepted theory responsible for spasmodic dysmenorrhea.

Non steroidal anti inflammatory Drugs were proved to be one of the alternative medications for spasmodic dysmenorrhea.

Getting the idea of what is called preemptive anesthesia by blocking the receptors before catching pain mediators the study participants will be divided randomly into 2 group group 1 receiving ttt 2 days before the anticipated menstruation and group 2 receiving ttt only during menstruation as analgesia

Eligibility criteria: Inclusion Criteria:

* nulliparous ladies
* with regular menstrual cycle pattern
* those experienced history of dysmenorrhea (primary or spasmodic)
* patients able to sallow tables

Exclusion Criteria:

* irregular cycles
* any associated local causes( pelvic infection, endometriosis, fibroid or others)
* patients with familial Mediterranean fever or other intermenstrual attacks of abdominal pain
* gastric or duodenal ulcers or gastritis
* other contraindications to non steroidal anti-inflammatory drugs
* patients with severe diminution of vision or color discrimination
* patients with any depressive or mood disorders
* patients receiving any hormonal treatment

Primary outcomes:
measure: change in the Degree of pain
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University
Study officials:
affiliation: Manoura University Hospital
name: Hanan Nabil, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05768971: Contrast-enhanced Ultrasound in Patients With Crohn´s Disease and Food Allergy
Official title: Conventional Ultrasound and Quantitative Dynamic Contrast-Enhanced Ultrasound (DCE-US) of the Bowel Wall in Patients With Food Allergy in Comparison to Crohn´s Disease and Healthy Controls
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Food Allergy
Lead sponsor: Friedrich-Alexander-Universität Erlangen-Nürnberg
Sponsor class: OTHER
First posted: 2023-03-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary-care university hospital, patients diagnosed and treated in the outpatient department for inflammatory and allergic bowel diseases

Brief summary: The purpose of this study is to investigate differences of the bowel wall thickness visible in conventional ultrasound and bowel perfusion using quantitative Contrast-Enhanced Ultrasound in patients with Crohn´s disease in comparison with healthy controls and patients with food allergy.

Detailed description: After being informed about the study and potential risks, all participants giving written consent will undergo conventional transabdominal ultrasound and Contrast-Enhanced Ultrasound of the bowel wall with measurement of the bowel wall thickness. In addition a continuous video sequence during Contrast-Enhanced Ultrasound is recorded and perfusion kinetics from the video clips are analyzed using a specific quantification software.

Eligibility criteria: Inclusion Criteria:

* Age over 18
* Endoscopically and histologically confirmed active Crohn´s disease or
* Previously proven food allergy (double-blind or single-blind food challenge tests with placebo controls previously before the sonographic examination, increased blood and / or intestinal Immunoglobulin E levels, elevated methylhistamine values under provocation and with reproducible reactions during food challenge procedures) or
* Healthy individuals without abdominal complaints

Exclusion Criteria:

* Age under 18
* Intolerance of the ultrasound contrast agent SonoVue
* Refusal of participation in the study
* Pregnancy or breast-feeding

Primary outcomes:
measure: Bowel wall thickness
timeFrame: T0: Baseline after mild diet. T1: After provocative diet (up to 30 days from T0)
measure: Peak Enhancement
timeFrame: T0: Baseline after mild diet. T1: After provocative diet (up to 30 days from T0)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Medicine 1, Divison of ultrasound medicine, University Hospital Erlangen
name: Dane Wildner, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03440671: The Safety and Efficacy Study of Hutox Versus Botox® in Subject With Moderate to Severe Glabellar Lines
Official title: A Multicenter, Double-Blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Compare the Efficacy and Safety Study of Hutox Versus Botox® in Subject With Moderate to Severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Glabellar Frown Lines
Lead sponsor: Huons Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-02-22
Enrollment: 260
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase Ⅲ Clinical Trial to Compare the Safety and Efficacy of Hutox versus Botox® in Subject with Moderate to Severe Glabellar Lines


Eligibility criteria: Inclusion Criteria:

* Facial Wrinkle Scale (FWS) score \> 2 when Subject knits brow extremely

Exclusion Criteria:

* Volunteer who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
* From screening, Subject who get a plastic Surgery including fascioplasty, Prosthesis implantation within 6 Weeks
* Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc
* Subject who takes a medication including anticoagulant, antithrombotic drug except low dose aspirin (below 325 mg/day)
* Any condition that, in the view of the investigator, would interfere with study participation

Primary outcomes:
measure: FWS(Facial Wrinkle Severity) Improvement at glabellar line
timeFrame: 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Huons
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT00215371: Study in Patients With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Pediatric
Formoterol Fumarate
Foradil
Lead sponsor: Dey
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 32
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control group.


Eligibility criteria: Inclusion Criteria:

* Require the regular use of an inhaled beta-2-selective adrenergic agent.
* No clinically significant abnormalities on the medical history, physical examination, and clinical laboratory tests.

Exclusion Criteria:

* Active acute or chronic disorders of the respiratory system within one month prior to screening.
* Smoking history within the past 12 months or greater than a lifetime 10 pack-year smoking history.
* Debilitating systemic and/or life-threatening diseases.

Primary outcomes:
measure: Primary: The primary efficacy outcome is measure of lung function.
Secondary outcomes:
measure: Secondary: Change in lung function will be examined as a secondary efficacy outcome, as well as vital signs, physical examination, adverse event reporting,etc.
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Research Site
state: California
city: Medford
country: United States
facility: Research Site
state: Oregon
Study officials:
References:
Clinical trial NCT00923871: Automating Breast Radiation Therapy (RT)
Official title: Automating the Breast Radiation Therapy Process to Improve Efficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: CBCT
Breast Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2009-06-18
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Breast radiation treatment is planned from a Computed Tomography (CT) scan. This study is designed to investigate a method to reduce the time between the planning of radiation treatment and its actual start by automating the intensity-modulated radiation therapy (IMRT) planning process. The investigators plan to examine data from another scan called Cone Beam Computed Tomography (CBCT). A CBCT scan provides similar information to a conventional CT scan, however the images for CBCT are acquired at the treatment unit (linear accelerator used for treatment). Using these x-ray pictures of patients, the study team consisting of a radiation oncologist, a medical physicist and a radiation therapist will create a custom treatment plan unique to each patient. By doing this, the investigators hope to reduce the amount of time spent waiting for treatment and the number of hospital visits for patients in the future.


Eligibility criteria: Inclusion Criteria:

* Patients with breast cancer who will receive standard two-field tangential whole breast radiation therapy with dose prescription of 4240 cGy in 16 fractions, 5000 cGy in 25 fractions or 4000 cGy in 16 fractions.
* Patients with any stage of breast cancer.
* Patients with prior treatment such as surgery or chemotherapy for any type of cancer.
* Able to provide a written informed consent.
* 18 years of age or older.

Exclusion Criteria:

* \< 18 years of age.
* Unable to provide informed consent.
* Males.
* Patients who received partial breast radiation and not the standard dose.
* Patients who will not receive 4240 cGy in 16 fractions, 5000 cGy in 25 fractions, or 4000 cGy in 16 fractions.

Primary outcomes:
measure: To generate on-line IMRT treatment plans using automated tools based on CBCT images acquired at the treatment unit.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Princess Margaret Hospital
name: Anne Koch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06545071: Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals With Co-Occurring Internalizing Disorders
Official title: Autonomous Digital CBT Intervention for Opioid Use Disorder in Individuals With Co-Occurring Internalizing Disorders - UG3
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Opioid Use Disorder
Anxiety
Depression
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 15
Sex: ALL
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: SUPPORTIVE_CARE

Brief summary: The primary objective of this protocol is to implement the UG3 phase (Phase 1) of a National Institute on Drug Abuse (NIDA) UG3/UH3 grant (RFA-DA-23-049). This phase is dedicated to the pilot testing of NEAT-O, a digital Cognitive Behavioral Therapy (CBT) program tailored for individuals with opioid use disorder (OUD) and concurrent anxiety or mood disorders - collectively referred to as internalizing disorders (INTDs). NEAT-O is based on an empirically supported CBT framework, specifically modified to address the complexities of comorbidity in substance use disorders (SUDs). This pilot study will evaluate the usability and acceptability of NEAT-O in 15 participants with OUD, with the goal of refining the program\&#39;s content and delivery methods. The results of the pilot study will inform a comprehensive RCT in the UH3 Phase (Phase 2) (N=300). Progression to the UH3 phase, with its funding, depends on meeting milestones in Phase 1 including demonstrating protocol adherence and the program\&#39;s acceptability and usability.


Eligibility criteria: Inclusion Criteria:

* Adults ages 18 to 65
* Current DSM-5 diagnosis of OUD (confirmed during MINI 7 interview)
* Current DSM-5 diagnosis of panic disorder with or without agoraphobia (PD/Ag) generalized anxiety disorder, social anxiety disorder, or major depression (confirmed during MINI 7 interview)
* Currently in treatment for OUD using MOUD
* Access to an internet-enabled smartphone for the duration of the study
* Currently residing in the United States
* Provision of informed consent

Exclusion Criteria:

* Current diagnosis of psychosis
* Current institutionalization (e.g., jail, hospital)
* Self-reported pregnancy
* Non-English Speakers

Primary outcomes:
measure: Acceptability
timeFrame: 45 days
measure: Usability
timeFrame: 45 days
measure: Attractiveness and Information Quality
timeFrame: 45 days
Secondary outcomes:
measure: Feasibility of EMA Collection Among Individuals with OUD
timeFrame: 45 days
measure: Recruitment and Retention Metrics
timeFrame: 45 days
measure: Preliminary Efficacy Indicators
timeFrame: 45 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04121871: Molecular Characterization of Candida Auris
Official title: Formulation Development and In-Vitro Studies of Efficacy of Botanical Extracts Against Candida Auris
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Fungal Infection
Keywords: Candida auris
Oral Fungal Infection
Candidiasis
Lead sponsor: Islamia University of Bahawalpur
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 384
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals are equally eligible to be selected in the study

Brief summary: Candida auris is emerging fungal opportunistic pathogen in developing countries. Much studies has been conducted on Candida albicans. there was a dire need to investigate this alarming threat. Our hypothesis is that by recording the patients diagnosed with oropharygneal candidiasis and collecting clinical swab samples from these patients will be fruitful if microbiological isolation, identification and molecular characterization will be done. So this is the first study on C. auris in south punjab, Pakistan. Aim of this study is to collect epidemiological data of C. auris.


Eligibility criteria: Inclusion Criteria:

* Pre-diagnosed Patients of both gender from pre-selected localities

Exclusion Criteria:

* Healthy individuals or individuals having no oral fungal infection individuals above 100 years of age

Primary outcomes:
measure: Prevalence of C. auris
timeFrame: From November 15, 2019 to February 29, 2020
measure: Seasonality of C. auris infection
timeFrame: From November 15, 2019 to February 29, 2020
measure: Drug susceptibility
timeFrame: From November 15, 2019 to February 29, 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Bahawalpur
country: Pakistan
facility: Bahawal Victoria Hospital Bahawalpur
state: Punjab
city: Bahawalpur
country: Pakistan
facility: Civil Hospital Jhangi Wala Road Bahawalpur
state: Punjab
Study officials:
affiliation: The Islamia University of Bahawalpur
name: Jafi H Shirazi, M.Phil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03447171: Prospective Evaluation of a Smartphone Application, GoCheckKids™, to Detect Amblyopia Risk Factors in Young Children
Official title: Prospective Evaluation of a Smartphone Application, GoCheckKids™, to Detect Amblyopia Risk Factors in Young Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amblyopia
Keywords: Amblyopia
Myopia
Hyperopia
Risk Factors
Amblyopia Risk Factors
Smartphone Application (App)
Photoscreening
Vision Screening
Mobile Vision Screening
Vision Screening App
Preschool children
Objective vision screening
Lead sponsor: Gobiquity Mobile Health
Sponsor class: INDUSTRY
First posted: 2018-02-27
Enrollment: 207
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be selected from eye clinics.

Brief summary: The objective is evaluation of GoCheck Kids, a smartphone application ('App'), for use as a photo screening device in a pediatric population to detect amblyopia risk factors (ARFs).

Detailed description: Detection of amblyopia risk factors using photo screening app in children of ages from 12 months to 8 years

Eligibility criteria: Inclusion Criteria:

* Age 12 months to 8 years inclusive.
* Informed consent given by parent or legal guardian.

Exclusion Criteria:

- History of ocular surgery and any condition that would preclude the ability of the investigator to obtain a reliable image and measurement

Primary outcomes:
measure: Sensitivity and specificity of amblyopia risk factors detected by Photorefraction
timeFrame: 1 day
Secondary outcomes:
measure: Number of patients with gaze error identified by photo screening
timeFrame: 1 day
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Children's Eye & Strabismus
state: Alaska
Study officials:
affiliation: Vanderbilt University
name: Sean Donahue, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: