louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05691296: The Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin
Official title: The Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myopia
High Myopia
Lead sponsor: Tianjin Eye Hospital
Sponsor class: OTHER
First posted: 2023-01-20
Enrollment: 4000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study aimed to collect multi-factor information on school-age children with pre-clinical myopia, and to identify the initial factors and warning signs of myopia.

Detailed description: The incidence of myopia is high in China. At present, the mechanism of myopia is unclear, and the main theories are genetic and environmental aspects. Many factors may affect the occurrence and development of myopia in students, such as ocular biological parameters, peripheral refractive state, differences in binocular vision function, eye habits, and outdoor time. In this study, the multi-factor information on pre-clinical myopia in school-age children was collected to find out the initial factors and warning signals of myopia.

Eligibility criteria: Inclusion Criteria:

* All students in grades 1 to 4
* Can cooperate with the examination of students

Exclusion Criteria:

* Obvious strabismus and amblyopia
* Eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases
* History of ocular surgery

Primary outcomes:
measure: The rate of new-onset myopia
timeFrame: Through study completion, an average of 1 year
measure: The changes of refractive error
timeFrame: Every 6 months, up to 3 years
measure: The changes of axial length
timeFrame: Every 6 months, up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tiajin Eye Hospital
state: Tianjin
Study officials:
References:
citation: Jonas JB, Ang M, Cho P, Guggenheim JA, He MG, Jong M, Logan NS, Liu M, Morgan I, Ohno-Matsui K, Parssinen O, Resnikoff S, Sankaridurg P, Saw SM, Smith EL 3rd, Tan DTH, Walline JJ, Wildsoet CF, Wu PC, Zhu X, Wolffsohn JS. IMI Prevention of Myopia and Its Progression. Invest Ophthalmol Vis Sci. 2021 Apr 28;62(5):6. doi: 10.1167/iovs.62.5.6.
Clinical trial NCT05843396: Brain Organization, Development, and Response to Intervention in Individual Neonates
Official title: Brain Organization, Development, and Response to Intervention in Individual Neonates
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Development, Infant
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Minnesota
First posted: 2023-05-06
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to learn about brain connectivity and if massaging babies shortly after birth has an impact. Half of the recruited babies will receive massage daily while the other half will not, and differences will be observed.


Eligibility criteria: Inclusion Criteria:

* English speaking
* Ability to give informed consent

Exclusion Criteria:

* Prisoners (vulnerable population)
* Pregnant women \<18 years of age
* Active psychosis, mania, suicidal ideation (safety)
* Active substance dependence
* Non-singleton pregnancy (e.g., twins)
* Gestational Age \<36 weeks (neonates)
* Neonatal encephalopathy (neonates)

Primary outcomes:
measure: Change in correlated brain activity among functional brain areas in the somatomotor cortex
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
References:
Clinical trial NCT04624386: Evaluating Oxidative Stress in Menopause
Official title: Evaluating Oxidative Stress in Postmenopausal Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause
Oxidative Stress
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 77
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women within 30-75 years of age were recruited to this study. Premenapusal healthy women who visited the clinic for routine gynecological control were included in the control group. Postmenopausal women older than 45 years of age who entered menopause as a natural process were included in the study group.

A total of 43 subjects were included in the study group and 34 subjects were included in the control group

Brief summary: Thiol disulfide levels will be determined using venous blood samples from pre- and postmenopausal women to evaluate oxidative stress in menopause. Furthermore, oxidative stress will be assessed according to age, and years since the start of menopause. Also, whether the presence of menopause related osteoporosis has any association with oxidative stress will be determined.

Detailed description: A total of 77 subjects are divided into two groups: study group (postmenopausal women) and control group premenopausal women). Biometric data such as age, bmi, obstetric anamnesis, history of komorbidities, PAP smear results are recorded. Mammography results, dexa scores of post menopausal women are also obtained. Venous blood samples from all subjects are collected. Thiol disulfide levels will be determined from serum samples. Thiol disulfide levels will first be compared between the study and the control group in order to determine the oxidative stress in menopause. In secondary evaluation years of menopause, age, and dexa scores will be included.

Eligibility criteria: Inclusion Criteria:

Women who entered menopause as a natural process Women within the age limits Still menstruating healthy women as control subjects

Exclusion Criteria:

Women who have entered menopause prematurely Women who have entered menopause following a surgery Women with medically induced menopause Women without any autoimmune or chronic inflammatory diseases Women who are taking hormone replacement therapy due to menopausal symptoms Women without any malignant diseases

Primary outcomes:
measure: Evaluating Oxidative Stress in Menopause
timeFrame: 2 months
Secondary outcomes:
measure: Evaluating Oxidative Stress According to Years of Menopause
timeFrame: 2 months
measure: Evaluating Oxidative Stress According to Menopause Related Osteoporosis
timeFrame: 2 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sisli Hamidiye Etfal Training and Research Hospital
Study officials:
affiliation: Sisli Hamidiye Etfal Training and Research Hospital
name: Nura Fitnat Topbas Selucki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00876486: Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol® in Recurrent or Metastatic Breast Cancer
Official title: A Open-label, Randomized, Parallel, Phase III Trial to Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol®(Conventional Paclitaxel With Cremorphor EL) in Subjects With Recurrent or Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2009-04-06
Enrollment: 213
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase III trial to evaluate the efficacy and safety of Genexol®-PM compared to Genexol® in subjects with recurrent or metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

Subjects should meet all of the following criteria to participate in the trial.

1. Subjects who aged 18 years or older.
2. Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial.
3. Subjects who have histologically or cytologically confirmed breast cancer with evidence of recurrence or metastasis.
4. If subjects have received Taxanes as neo-adjuvant or adjuvant therapy, the subjects should have relapsed with breast cancer after 12 months of completing neo-adjuvant or adjuvant therapy with Taxanes.
5. Subjects who have measurable disease in accordance with the RECIST criteria

Primary outcomes:
measure: Objective Response Rate
timeFrame: 6 months
Secondary outcomes:
measure: Overall Survival, Progress Free Survival, Time to Tumor Progression, Duration of Overall Response
timeFrame: Event driven
measure: Safety and toxicity
timeFrame: Throughout study
Other outcomes:
Locations:
city: Goyang-si, Gyeonggi-do
country: Korea, Republic of
facility: National Cancer Center
Study officials:
References:
Clinical trial NCT01622686: PlainLanguageRx: Improving Medication Labels to Reduce Health Disparities
Official title: PlainLanguageRx: Improving Medication Labels to Reduce Health Disparities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Medication Adherence
Keywords: Prescription Labels
Low Health Literacy
Limited English Proficiency
Spanish
Lead sponsor: PictureRx, LLC
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2012-06-19
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This randomized controlled trial seeks to test the effect of reformatted prescription drug container labels, compared to usual labels, on participants' understanding of their medications. The study will also assess the effect on self-efficacy and self-reported medication adherence. English and Spanish speaking patients are eligible, with a planned sample size of up to 500 adults.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years old,
* Fluency in English or Spanish
* Manage their own prescription medicines, and
* Have recently filled at least 1 new prescription medication (e.g, a medicine or medication dose that they have not taken before) and have their new prescription bottle information with them.

Exclusion Criteria:

* Excludes health professionals (such as a doctor, nurse or pharmacist)
* Too ill to participate in an interview
* Do not have a telephone
* Having visual acuity worse than 20/50 via Rosenbaum Visual Acuity exam (eyechart)
* Persons picking up new medicines for others
* Inability to communicate in either Spanish or English
* Overt psychiatric illnesses, overt delirium or dementia

Primary outcomes:
measure: Patient understanding of their medication regimen.
timeFrame: Approximately 7 days
Secondary outcomes:
measure: Self-efficacy
timeFrame: Approximately 7 days
measure: Self-reported adherence
timeFrame: Approximately 7 days
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: PictureRx, LLC (SAI Interactive)
state: Tennessee
Study officials:
affiliation: PictureRx, LLC
name: M Brian Riley, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03908086: Bloodstream Infections in Patients With Rheumatoid Arthritis
Official title: Incidence and Risk Factors of Staphylococcus Aureus Bacteremia in Patients With Rheumatoid Arthritis Compared With the General Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Staphylococcus Aureus Bacteremia
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: University of Aarhus
name: Statens Serum Institut
First posted: 2019-04-09
Enrollment: 6000000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All individuals alive and living in Denmark on December 31, 1996 as identified by the Civil Registration System are included. Individuals are dynamically included during the study period if they immigrate or turn 18. Individuals are followed up until first-time SAB, death, emigration or December 31, 2017, whichever comes first.

Brief summary: Study of incidence and risk factors of staphylococcus aureus bacteremia in patients with rheumatoid arthritis compared with the general population in a nationwide cohort of all adult members of the population from 1996 until 2017 using national registries


Eligibility criteria: Inclusion Criteria:

* All members of the adult Danish population

Exclusion Criteria:

* Staphylococcus aureus bacteremia prior to inclusion.
* Rheumatoid arthritis diagnosed prior to inclusion.

Primary outcomes:
measure: Incidence of staphylococcus aureus bacteremia
timeFrame: 0-21 years
measure: Incidence rate ratios
timeFrame: 0-21 years
Secondary outcomes:
measure: Risk factors of staphylococcus aureus bacteremia
timeFrame: 0-21 years
Other outcomes:
Locations:
Study officials:
References:
citation: Dieperink SS, Glintborg B, Oestergaard LB, Norgaard M, Benfield T, Mehnert F, Petersen A, Hetland ML. Risk factors for Staphylococcus aureus bacteremia in patients with rheumatoid arthritis and incidence compared with the general population: protocol for a Danish nationwide observational cohort study. BMJ Open. 2019 Sep 3;9(9):e030999. doi: 10.1136/bmjopen-2019-030999.
Clinical trial NCT03802786: Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects
Official title: An Open-label, Single-dose, Parallel-group Study to Assess the Pharmacokinetics of Imeglimin in Subjects With Moderate Hepatic Impairment Compared to Matched Healthy Control Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Keywords: pharmacokinetics
Lead sponsor: Poxel SA
Sponsor class: INDUSTRY
First posted: 2019-01-14
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, single-centre, open-label, parallel-group study in subjects with moderate hepatic impairment and subjects with normal hepatic function. Child-Pugh (CP) scoring will be used to determine hepatic impairment.


Eligibility criteria: Inclusion Criteria:

* Caucasian
* BMI :18.0 and 40.0 kg/m2 and weight ≥50 kg.
* Stable hepatic impairment or normal hepatic function for healthy volunteer
* No clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (Subjects with moderate hepatic impairment may have medical findings consistent with their hepatic dysfunction)
* Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception
* Informed consent signature

Exclusion Criteria:

* Clinically relevant abnormal findings at the screening assessment
* Severe adverse reaction to any drug or sensitivity to the trial medication or its componentsClinically significant vital signs outside the acceptable range at screening
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
* Drug or alcohol abuse
* Positive test HIV
* Smoking more than 10 cig/day
* Participation in other clinical trials of unlicensed or prescription medicines

Exclusion criteria for healthy volunteer

* Positive test for HBV, HBC
* eGFR less than 90 mL/min/1.73 m2
* liver diseases

Exclusion criteria for hepatic impaired

* eGFR less than 80 mL/min/1.73 m2
* Hepatic impairment due to non liver disease
* History of hepatocellular carcinoma or acute liver disease
* CLinically significant change in liver disease status within 6 months
* ascites
* encephalopathy grade III or IV

Primary outcomes:
measure: PK parameters of imeglimin
timeFrame: At Day 1
Secondary outcomes:
measure: PK parameters of imeglimin
timeFrame: From day 1 to day 2
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: From day 1 to day 7
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Apex
Study officials:
affiliation: Poxel SA
name: Clémence Chevalier
role: STUDY_DIRECTOR
References:
Clinical trial NCT02041286: Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System
Official title: User Performance of the Karajishi Contour Blood Glucose Monitoring System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Ascensia Diabetes Care
Sponsor class: INDUSTRY
First posted: 2014-01-22
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine if subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) without training and obtain valid glucose results.


Eligibility criteria: Inclusion Criteria:

* Males and females, 18 years of age and older
* People with type 1 or type 2 diabetes
* Able to speak, read, and understand English
* Willing to complete all study procedures

Exclusion Criteria:

* Hemophilia or any other bleeding disorder
* Pregnancy
* Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM
* Previously participated in a BG monitor study using the Karajishi BGMS (or used a Bayer Contour meter)
* Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
* Working for a competitive medical device company, or having an immediate family member who works for such a company
* A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk

Primary outcomes:
measure: Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
Secondary outcomes:
measure: Number of Venous Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
measure: Number of Blood Glucose (BG) Results From Alternative Site Testing (AST) Palm Blood Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method
timeFrame: 1 hour
measure: Number of Subject Fingerstick Blood Glucose (BG) Results Within +/- 15 mg/dL (<100 mg/dL) and Within +/- 15% (>=100 mg/dL) of Laboratory Glucose Method When Obtained and Tested by Study Staff
timeFrame: 1 hour
measure: Number of Subject Responses That Strongly Agree or Agree or Are Neutral With Questionnaire Statements
timeFrame: 1 hour
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
affiliation: Rainier Clinical Research Center
name: Leslie J Klaff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AMCR Institute
name: Timothy Bailey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03883386: Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use
Official title: Loratadine for Improvement of Bone Pain in Patients With Chronic Granulocyte-Colony Stimulating Factor (G-CSF) Use
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Bone Pain
Keywords: Granulocyte-colony stimulating factor
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 3
Sex: ALL
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: G-CSF causes a release of histamine that may be a cause of chronic bone pain. Loratadine targets histamine, and so may be effective in reducing bone pain.The researchers plan to prospectively assess the effectiveness of loratadine for chronic bone pain in patients with chronic G-CSF use.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of neutropenia
* Granulocyte-colony stimulating factor (G-CSF) use for at least 3 months at least 4 times per month
* Mean bone pain of at least a 2/10 as assessed by questions 3-6 of the Brief Pain Inventory (BPI)

Exclusion Criteria:

* Other sources of chronic pain
* Previously tried loratadine for 7 consecutive days or more for bone pain
* Allergy to loratadine
* Chronic daily usage of antihistamine without an acceptable alternative non-antihistamine medication

Primary outcomes:
measure: Change in Pain Severity Scores as Measured by the Brief Pain Inventory (BPI)
timeFrame: Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine).
Secondary outcomes:
measure: Change in Pain Interference in Patients as Measured by the Brief Pain Inventory (BPI)
timeFrame: Week 1 (baseline week), week 2 (placebo or loratadine), and week 4 (placebo or loratadine).
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Kelly Walkovich
role: PRINCIPAL_INVESTIGATOR
References: