louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05403528: Technology/Digital Media Use and Children's Word Learning Development
Official title: Technological Timescales: Identifying the Impact of Digital Media on the Mechanisms of Word Learning
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-06-03
Enrollment: 0
Sex: ALL
Minimum age (years): 17
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of for conditions.
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this work is to address increasing concerns about young children's digital media exposure and language outcomes by testing how the times course of word learning unfolds in digital environments and the cascading impact of digital media on vocabulary outcomes. The findings will have important implications for understanding when and where optimal word learning from media can occur.

Detailed description: The goal of the current proposal is to identify how digital media alters the mechanisms of word learning and subsequently impacts the lexical foundation on which a child's vocabulary is built. Specifically, the proposal aims to identify the impact of digital media on 1) the processes underlying real-time word learning, and 2) the processes of language generalization and vocabulary growth. Specific Aim 1 will use a novel word learning task to test children's ability to map and retain new words within and between digital media (2D images on a tablet) and real world objects (3D objects). Specific Aim 2 will probe children's novel label generalization abilities within and between 2D and 3D modalities using a novel noun generalization task. Further, individual differences in a child's prior technology experience will be measured and used to predict overall vocabulary as well as performance within and between each task.

Eligibility criteria: Inclusion Criteria:

* between 17-30 months old

Exclusion Criteria:

* diagnosed developmental delay or disorder
* exposure to more than 25% of another language

Primary outcomes:
measure: Accuracy on selecting the target item on referent selection
timeFrame: 1 minute
measure: Accuracy on selecting the target item on retention
timeFrame: 5 minutes
measure: Accuracy on selecting the target item on novel noun generalization task
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Stillwater
country: United States
facility: Oklahoma State University
state: Oklahoma
Study officials:
References:
Clinical trial NCT01253928: Pioglitazone, Body Composition,Insulin Sensitivity and Protein Metabolism in ESRD
Official title: Effects of Pioglitazone on Body Composition,Insulin Sensitivity and Protein Metabolism in ESRD Non Diabetic Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: ESRD
Keywords: body composition
insulin sensitivity
protein metabolism
pioglitazone
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2010-12-06
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Non diabetic patients on renal replacement therapy are prone to changes in body composition with an increase in visceral fat and muscle wasting all favoured by the insulin resistant state. Malnutrition is associated with a worst prognosis in these patients. Glitazones are the most powerful insulin sensitisers available in clinical practice which also have anti-inflammatory properties. Their use has been associated with significant and favourable changes in body fat distribution in type 2 diabetic subjects. Experimental studies suggest that glitazones may attenuate muscle wasting in renal failure.

The goal of this study was to examine in non diabetic ESRD patients the effects of pioglitazone on inulin sensitivity and protein metabolism as determined by the hyperinsulinemic euglycemic clamp and on changes in body composition as determined by anthropometric measurements, dual energy X-ray absorptiometry (DEXA) and CT-scan determined changes in abdominal visceral and sub-cutaneous fat.


Eligibility criteria: Inclusion Criteria:

Non diabetic individuals with ESRD, on hemodialysis or peritoneal dialysis for at least 3 months. Consent form signed -

Exclusion Criteria:

No infectious complication 3 months prior to entry in the study.

-

Primary outcomes:
measure: Body composition
timeFrame: at the end of each treatment phase (which lasts 4 months)
measure: Insulin sensitivity
timeFrame: at the end of each treatment phase (which lasts 4 months)
measure: Protein metabolism
timeFrame: at the end of each treatment phase (which lasts 4 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Nephrology Service Department of Medicine CHUV
state: Vaud
Study officials:
affiliation: CHUV Lausanne
name: Anne Zanchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zanchi A, Tappy L, Le KA, Bortolotti M, Theumann N, Halabi G, Gauthier T, Mathieu C, Tremblay S, Bertrand PC, Burnier M, Teta D. Pioglitazone improves fat distribution, the adipokine profile and hepatic insulin sensitivity in non-diabetic end-stage renal disease subjects on maintenance dialysis: a randomized cross-over pilot study. PLoS One. 2014 Oct 16;9(10):e109134. doi: 10.1371/journal.pone.0109134. eCollection 2014.
Clinical trial NCT01932528: An Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate in Males
Official title: A Phase 1, Open-label, Non-randomised, Single-dose Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate (LX1606) in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Carcinoid Syndrome
Keywords: Absorption
Metabolism
Excretion
Lead sponsor: Lexicon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-08-30
Enrollment: 8
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and its primary metabolite LX1033.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects aged 30 to 65 years of age.
* Male subjects and their partners must agree to use an adequate method of contraception
* Historically able to produce a minimum of 1 bowel movement every day on most days

Exclusion Criteria:

* Female subjects
* Use of any medication or supplement within 5 days prior to Dosing
* Radiation exposure exceeding 5 millisieverts (mSv) in the last 12 months or 10 mSv in the last 5 years
* Current smokers or the use of cigarettes within 90 days prior to Screening
* History or renal disease or abnormal kidney function
* History of hepatic disease
* Acute diarrhea or constipation within 7 days of dosing
* Positive urine glucose at Screening

Primary outcomes:
measure: Maximum plasma concentration of LX1606 and LX1033
timeFrame: 7 days
Secondary outcomes:
measure: Time to maximum plasma concentration of and LX1033
timeFrame: 7 days
measure: Determination of total radioactivity in blood and plasma
timeFrame: 7 days
measure: Mass balance recovery of total radioactivity in urine and feces
timeFrame: 7 days
measure: Metabolite profiling and identification in plasma
timeFrame: 7 days
measure: Metabolic profiling and identification in urine
timeFrame: 7 days
measure: Metabolic profiling and identification in feces
timeFrame: 7 days
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Lexicon Investigational Site
Study officials:
affiliation: Lexicon Pharmaceuticals, Inc.
name: Doug Fleming, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06663228: Rapid Histologic Assessment for Stereotactic Breast Biopsy: Enhancing Early Detection With Miniature Mass Spectrometry and AI
Official title: Rapid Histologic Assessment for Stereotactic Breast Biopsy: Enhancing Early Detection With Miniature Mass Spectrometry and AI
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: breast cancer
breast biopsy
miniature mass spectrometry
artificial intelligence
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females with abnormal mammography findings, that were categoried as ACR BI-RADS 4 or 5, come for vacuum-assisted stereotactic breast biopsy.

Brief summary: Breast cancer is the leading cancer among Taiwanese women, and it is the second leading cause of cancer-related deaths in women. The five-year survival rate for early-stage breast cancer (Stage 0 to II) is over 90%, significantly better than the survival rates for Stage III and Stage IV breast cancer, which are approximately 70% and 25%, respectively. As a result, breast cancer screening and early diagnosis have always been of great importance. Breast cancer screening relies on imaging examinations, and the diagnosis depends on imaging-guided tissue confirmation.

However, when a patient undergoes stereotactic breast biopsy due to suspicious lesions found in mammography, they typically have to wait about a week to receive the pathology results to determine whether the lesion is benign or malignant. For the patient, this waiting period can be agonizing, and for clinicians, earlier knowledge of pathology results would facilitate prompt staging evaluation and treatment planning for cancer.

The investigators use a special technique-paper spray ionization miniature mass spectrometry (PSI-MMS). According to preliminary research, with the assistance of AI, the miniature mass spectrometer can detect the benign or malignant nature of breast tissue within minutes and with decent accuracy. The investigators hope to continue research to further improve accuracy to meet clinical needs and aspire to have the opportunity to apply the miniature mass spectrometer to rapidly differentiate the molecular subtypes of breast cancer.


Eligibility criteria: Inclusion Criteria:

* Those who come for receiving vacuum-assisted stereotactic breast biopsy

Exclusion Criteria:

* Those who cannot or are unwilling to sign the informed consent.

Primary outcomes:
measure: breast cancer
timeFrame: July 2024 to July 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Jo-Yu Chen
Study officials:
References:
Clinical trial NCT01507961: Comparison of Soft and Hard Tissue Thickness in the Anterior Regions of the Upper and Lower Jaws Taken From CBCT Versus Clinical Measurements
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Soft and Hard Tissue Biotype
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-01-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 subjects who have done a CT

Brief summary: Hypothesis: there is a positive correlation between tissue thickness measured from CBCT and clinical measurements.


Eligibility criteria: Inclusion Criteria:

* 100 subject who have done a CT

Exclusion Criteria:

* periodontal surgery in anterior regions, medications which effect the gingiva

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT07025161: Brief Mindfulness Intervention for Patients at a Free Acute Care Clinic
Official title: Brief Behavioral Intervention for Pain (Shepherd's Hope)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded mindfulness intervention for 100 English-speaking patients and 100 Spanish-speaking patients at a free acute care clinic will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.


Eligibility criteria: Inclusion Criteria:

* Age ≥18
* Seeking treatment at the Shepherd's Hope Downtown Clinic

Exclusion Criteria:

* Cognitive impairment preventing completion of study procedures.
* Other unstable illness judged by medical staff to interfere with study involvement.

Primary outcomes:
measure: Change in Pain Unpleasantness Numeric Rating Scale
timeFrame: Immediately before to after 4-minute audio recording
Secondary outcomes:
measure: Change in Pain Intensity Numeric Rating Scale
timeFrame: Immediately before to after 4-minute audio recording
measure: Change in Anxiety Numeric Rating Scale
timeFrame: Immediately before to after 4-minute audio recording
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Shepherd's Hope Downtown Clinic
state: Florida
Study officials:
References:
Clinical trial NCT04018911: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_20
Official title: Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2019-07-15
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will be treated with each sound changing principle (Noise Reduction principle (NR)) in a randomized order.
Primary purpose: TREATMENT

Brief summary: A methodical evaluation of novel sound changing principles in CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. These sound changing principles are enabled by respective hearing instrument technologies and hearing instrument algorithms. The aim of the study is to investigate and asses strength and weaknesses of these novel sound changing principles in terms of hearing performance to determine their application in hearing instruments (Phase of development). Both, objective laboratory measurements as well as subjective evaluations in real life environment will be carried out. This will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at Sonova AG Headquarter based in Stäfa


Eligibility criteria: Inclusion Criteria:

* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire conscientiously
* Informed Consent as documented by signature

Exclusion Criteria:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product

  * Limited mobility and not in the position to attend weekly appointments
  * Limited ability to describe listening impressions/experiences and the use of the hearing aid
  * Inability to produce a reliable hearing test result
  * Massively limited dexterity
  * Known psychological problems
  * Known central hearing disorders
  * colour blinded

Primary outcomes:
measure: sound quality ratings
timeFrame: 4 weeks
Secondary outcomes:
measure: Oldenburg sentence test & reaction time task
timeFrame: 3 weeks
measure: Oldenburg Sentence test (Olsa)
timeFrame: 4 weeks
measure: Adaptive Categorial Listening Effort Scaling (ACALES)
timeFrame: 3 weeks
measure: qualitative interview form
timeFrame: 3 weeks
Other outcomes:
measure: Non-verbal Trail Making Test A & B
timeFrame: 1 week
measure: color-word-interference test by J.R.Stroop
timeFrame: 1 week
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
Study officials:
affiliation: Sonova AG
name: Juliane Raether
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06006611: Risk Factors for Severe Disease in Hospitalized Patients With COVID-19 and the Effect of Azvudine Treatment: a Retrospective Cohort Study
Official title: Risk Factors for Severe Disease in Hospitalized Patients With COVID-19 and the Effect
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19
Keywords: COVID-19
Azvudine
severity
Lead sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 4201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The COVID-19 positive patients

Brief summary: The purpose of this study is to explore the factors that can affect the development of severe cases in hospitalized patients with COVID-19, including basic diseases, laboratory parameters, and clinical manifestations; In addition,to explore whether Azvudine can reduce the mortality of hospitalized patients with COVID-19.

Detailed description: 4201 COVID-19 patients discharged from our hospital were enrolled. Binary logistic regression analysis and ROC curve were used to investigate the role of comorbidities, laboratory parameters and clinical manifestation on progression of COVID-19 patients. We used propensity-score models conditional on baseline characteristics and Univariate Cox regression model to examine whether Azvudine can reduce the mortality of COVID-19 patients.

Eligibility criteria: Inclusion Criteria:

The COVID-19 positive patients

Exclusion Criteria:

1. patients treated with both azvudine and monotamivir;
2. patients receiving other antiviral drugs such as nematavir/ritonavir;
3. age \&lt; 18 years old

Primary outcomes:
measure: All-cause mortality of COVID-19 patients
timeFrame: Time from onset to death
Secondary outcomes:
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT03106311: The Use of Quantitative Pregnancy Test in Amniotic Fluid as a Diagnostic Tool for Rupture of Fetal Membranes
Official title: Use of Beta Subunit of Human Chorionic Gonadotropin Assay as a Diagnostic Tool for Premature Rupture of Membranes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Rupture of Membrane
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 100
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Two groups will be recruited. The first group are pregnant ladies that have unequivocal rupture of fetal membranes that is diagnosed by seeing the amniotic fluid leakage in the vagina. The second group are normal pregnant ladies without rupture of membranes. both groups will be tested by taking vaginal washing fluid. Quantitative and qualitative pregnancy tests will be measured in this fluid.

Detailed description: Beta subunit of human chorionic gonadotropin assay will be measured in the vaginal washing in two groups. The first group are pregnant women in the second or third trimester. These women have definite rupture of membranes diagnosed by visual leaking of the amniotic fluid from the cervix during speculum examination. The second group are pregnant women with intact membranes. Assessment of both the qualitative and quantitative beta subunit of human chorionic gonadotropin will be done

Eligibility criteria: Inclusion Criteria:

* Pregnant women between 14 and 40 weeks gestation with history of gush of vaginal fluid
* Pregnant women between without history of gush of vaginal fluid

Exclusion Criteria:

* Presence of vaginal bleeding
* Presence of any obstetric emergency as cord prolapse

Primary outcomes:
measure: Concentration of beta subunit of human chorionic gonadotropin
timeFrame: This outcome will be measured within 20 minutes of collection of vaginal washing fluid. The collection of vaginal washing fluid will be done by an investigator upon admission to the department of Obstetrics
Secondary outcomes:
measure: Presence or absence of positive qualitative pregnancy test
timeFrame: Qualitative pregnancy test will be done in the vaginal washing fluid by an investigator within 20 minutes from admission to the Obstetrics department.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital
state: Greater Cairo
Study officials:
affiliation: Cairo University
name: Eman Omran, M.D.
role: PRINCIPAL_INVESTIGATOR
References: