louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05963503: Relationship Between Health Literacy and Physical Activity in Adult Patients With Cystic Fibrosis
Official title: Investigation of Relationship Between Health Literacy and Physical Activity, Anxiety and Depression, Adherence to Airway Clearance Techniques in Adult Patients With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cystic Fibrosis
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cystic fibrosis and healthy participants between 18-65 years old.

Brief summary: The purpose of this study investigation of relationship between health literacy and physical activity, anxiety and depression, adherence to airway clearance techniques in adult patients with cystic fibrosis.

Detailed description: The assessment will begin with demographic information then health literacy, depression and anxiety and physical activity level will evaluation with related questionnaires.

Eligibility criteria: Inclusion Criteria:

be between the ages of 18-65 volunteering to participate

Exclusion Criteria:

having any cardiopulmonary disease having cognitive problems being illiterate

Primary outcomes:
measure: Health Literacy
timeFrame: 5 minutes
Secondary outcomes:
measure: Anxiety and Depression
timeFrame: 5 minutes
measure: Physical Activity
timeFrame: 3 minutes
measure: Adherence to Airway Clearance Tecniques
timeFrame: 1 minute
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Naciye Vardar Yağlı
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Ebru Damadoğlu
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Oğuz Karcıoğlu
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Aydan Aslı Aksel Uylar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01613703: ONO-2952 Single-dose PET Study in Healthy Adult Subjects
Official title: Open-Label, Single-Center, Single Dose Positron Emission Topography (PET) Using [11C]PBR28 to Evaluate Brain Translocator Protein 18KDa (TSPO) Occupancy of ONO-2952 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Subjects
Keywords: ONO-2952
Healthy adult subjects
single doe
PET study
Safety
Tolerability
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2012-06-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the brain TSPO occupancy of ONO-2952 in healthy adult subjects after a single dose using \[11C\]PBR28 as a specific PET ligand for TSPO. The secondary objective is to evaluate the relationship between TSPO occupancy and the plasma concentration of ONO-2952 and to investigate the safety and tolerability of ONO-2952 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy non-smoking male or female subjects (18-55 inclusive)
* Body mass index (BMI) of 19-35 kg/m2 (inclusive)
* For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception

Exclusion Criteria:

* History or presence of clinically significant disease

Primary outcomes:
measure: To evaluate the brain TSPO occupancy of ONO-2952 in healthy adult subjects after a single dose using [11C]PBR28 as a specific PET ligand for TSPO
timeFrame: 2 days
Secondary outcomes:
measure: To evaluate the relationship between TSPO occupancy and the plasma concentration of ONO-2952
timeFrame: 2 days
measure: To investigate the safety and tolerability of ONO-2952 in healthy adult subjects
timeFrame: 14 days
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Pittsburgh Clinical Site
state: Pennsylvania
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Ono Pharma USA, Inc.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06428903: Comparative Bioavailability Study of Tablet and Granule Formulations of ADC189 and the Study of Ultra-high Dose
Official title: A Comparison Study of ADC189 Bioavailability Between Tablet and Granule in Healthy Chinese Adult Male Subjects, and the Safety and Pharmacokinetics of Ultra-high Dose ADC189
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Jiaxing AnDiCon Biotech Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-05-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Part 1 of this study will compare the pharmacokinetic performance of tablet and granule formulations of ADC189 under fasted conditions in healthy volunteers. A randomized, two-period, two-treatment crossover design is used. In each period, each volunteer will receive a single oral dose of the tablet or granule formulation without food.

The purpose of Part 2 study is to determine the safety and pharmacokinetics of ultra high dose of ADC189 in healthy subjects.

Detailed description: In Part 1 study, a total of 32 subjects were randomly divided into two groups, A and B, with 16 subjects in each group. After a 28-day screening period, on the first day of Period 1 (D1), subjects in group A took ADC189 granules (a single oral dose, 45mg), and subjects in group B took ADC189 tablets (a single oral dose, 45mg), all subjects were under fasted conditon. In Period 2, two groups will change to the fomulation which is different in Period 1 respectively, and all the steps will keep the same as Period 1. Each period lasts for 15 days, and have a 7-day interval between 2 periods. Blood samples will be taken, pharmacokinetic and saftey profiles will be observed.

In Part 2 study, the ultra high dose of ADC189 (a single oral dose, 180mg) will applied in 8 healty adult male subjects. The pharmacokinetic and saftey profiles will be observed during the following 15 days, and blood sample will be taken.

Eligibility criteria: Inclusion Criteria:

* 1. Healthy male subjects aged 18-45 years old
* 2. Male subjects weight over 50 kg

Exclusion Criteria:

* 1. Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
* 2. Have a history of drug abuse in the past five years or use drugs in the three months prior to screening
* 3. Blood donation or blood loss \> 400 mL in 3 months before screening

Primary outcomes:
measure: ADC189 Granules
timeFrame: 15 days
measure: ADC189 Tablet
timeFrame: 15 days
measure: ADC189 Ultra high dose
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Zhao Wei
state: Shang Dong
Study officials:
References:
Clinical trial NCT05434403: Transauricular Vagus Nerve Stimulation in the Treatment of Chemotherapy-induced Peripheral Neuropathy
Official title: Transauricular Vagus Nerve Stimulation in the Treatment of Chemotherapy-induced Peripheral Neuropathy: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CIPN
Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2022-06-28
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chemotherapy induced peripheral neuropathy is common in tumor patients receiving chemotherapy. Nowaday, CIPN is mainly treated with drugs, but the therapeutic effect is not satisfactory. Previous studies have found that inflammatory immune mechanism plays an important role in neuropathic pain. Vagus nerve stimulation can not only relieve pain by regulating the autonomic nervous system, but also participate in the immune response. Investigators hope that the treatment by vagus nerve electrical stimulation through ear skin can improve the pain and neurotoxicity scores of CIPN patient.If it is proved that vagus nerve stimulation can effectively treat CIPN, it will become a simple and safe non-drug treatment which has good application prospects.


Eligibility criteria: Inclusion Criteria:

1. Patient is currently receiving chemotherapy drugs with neurotoxicity
2. New or worsening numbness and / or pain in the hands and / or feet, and no other cause explains the above symptoms

Exclusion Criteria:

1. Patients with sinus bradycardia, long QT syndrome, sick sinus syndrome or other arrhythmias, mental diseases, cardiac pacemakers or other electrical stimulation devices after implantation.
2. Patients taking analgesics due to pain in other parts of the body.

Primary outcomes:
measure: NRS(numerical rating scale)
timeFrame: Day0
measure: NRS(numerical rating scale)
timeFrame: Day3
measure: NRS(numerical rating scale)
timeFrame: Day5
measure: NRS(numerical rating scale)
timeFrame: Day8
measure: NRS(numerical rating scale)
timeFrame: Day14
measure: NRS(numerical rating scale)
timeFrame: Day30
measure: NRS(numerical rating scale)
timeFrame: Day60
measure: NRS(numerical rating scale)
timeFrame: Day90
Secondary outcomes:
measure: NCI-CTC v4.0 neurotoxicity classification
timeFrame: Day1,Day3,Day5,Day8,Day14,Day30,Day60,Day90
measure: QST( Quantitative Sensory Testing)
timeFrame: Day1,Day14
measure: IL-2，IL-4，IL-6，IL-10，IFN-γ，TNF-α
timeFrame: Day1,Day14
measure: Athens insomnia scale
timeFrame: Day1,Day8,Day14,Day30,Day60,Day90
measure: SF-12，Short From health survey -12
timeFrame: Day1,Day8,Day14,Day30,Day60,Day90
Other outcomes:
Locations:
city: Beijing
country: China
facility: People's Hospital of Peking University
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Yi Feng, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05503303: T1D, Metabolic Syndrome and Insulin Resistance
Official title: Clinical Characteristics in Adults With Type 1 Diabetes, Metabolic Syndrome and Insulin Resistance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Metabolic Syndrome
Insulin Resistance
Lead sponsor: Universidad Juárez Autónoma de Tabasco
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who attend Diabetes Clinic of the Regional Hospital of High Specialty "Dr. Gustavo A. Rovirosa Pérez", previously diagnosed with type 1 diabetes

Brief summary: Patients with type 1 diabetes (T1D) and metabolic syndrome (MS) require high doses of insulin to achieve a glycemic control, due to insulin resistance (IR). The investigators identified the presence of metabolic syndrome and insulin resistance in patients with T1D in a population of southeast Mexico.

The sampled population was recruited from the Diabetes Clinic of the Regional Hospital of High Specialty "Dr. Gustavo A. Rovirosa Pérez"; from August 2021 to February 2022, graduated physicians interviewed patients previously diagnosed with T1D. This study included patients older than 18 years and at least six months after being diagnosed with T1D. The interviewers excluded patients who did not attend regular consultations and those who did not agree to participate or to give a blood sample. A diabetologist evaluated and diagnosed all patients based on the World Health Organization (WHO) criteria.

Fasting glucose, total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols were determined in blood serum using a Clinical Chemistry System from Random Access Diagnostics. The reasearch team determined glycated hemoglobin concentrations by an enzymatic immunoassay method.


Eligibility criteria: Inclusion Criteria:

* At least six months after being diagnosed with T1D

Exclusion Criteria:

* Did not attend regular consultations
* Did not agree to participate or to give a blood sample

Primary outcomes:
measure: Glycated hemoglobin
timeFrame: March 2022
measure: Total cholesterol, HDL cholesterol, LDL cholesterol, and triacylglycerols
timeFrame: March 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Villahermosa
country: Mexico
facility: Isela Esther Juarez Rojop
state: Tabasco
Study officials:
References:
Clinical trial NCT03494803: Detection of Prostate Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC
Official title: Clinical Trials on Detection of Prostate Cancer With Non-invasive Method Based on DNA Methylation of Circulated Tumor DNA, PBMC and T Cells
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Prostate Cancer Metastatic
Lead sponsor: HKGepitherapeutics
Sponsor class: INDUSTRY
Collaborators: name: Kazakh Research Institute of Oncology & Radiology
First posted: 2018-04-11
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be assigned an ID that will be kept confidential according to hospital regulations. IDs will be randomized so that identity will not be revealed except to the approved hospital personnel. Methylation data will be returned to the hospital for follow up of progression of disease and for assessing early prediction of progression of Prostate cancer and will be entered into the data base. Other clinical follow up data will be entered into the electronic data base. All data will be captured in case report form

Brief summary: Prostate cancer is a leading cause of mortality and morbidity.

The purpose of this study is to develop and test non-invasive biomarkers based on methylation changes in PBMC, T-cells and circulated tumor DNA in prostate cancer patients.


Eligibility criteria: Inclusion Criteria:

* Informed consent: The patient must sign the appropriate approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

* Pregnant women
* Minors (subjects less than 18 years of age)
* Prisoners
* Patients having other than one cancer
* Subjects unable to consent for themselves
* Symptomatic of acute prostatitis

Primary outcomes:
measure: DNA methylation of circulated tumor and PBMC DNA and its Correlation to Development and prediction of prostate cancer
timeFrame: 6 months to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Kazakh Institute of Oncology and Radiology
Study officials:
References:
Clinical trial NCT02562703: tVNS for Depression
Official title: Transcutaneous Vagus Nerve Stimulation for Treating Major Depressive Disorder: a Phase II, Randomized, Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Depressive Disorder
Lead sponsor: Santa Casa Medical School
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase II, randomized, sham controlled, clinical trial. This clinical trial has as primary objective to evaluate changes in depressive symptoms of a transcutaneous Vagus Nerve Stimulation (tVNS) treatment protocol for patients with moderate / severe depressive episode.


Eligibility criteria: Inclusion Criteria:

1. patients between 18 and 69 years
2. patients with a diagnosis of depression according to the SCID
3. score greater than or equal to 18 on the Hamilton Rating Scale 17-item version (equivalent to moderate or severe depressive episode)
4. agreement to participate in the study as recommended in the IC.

Exclusion Criteria:

1. patients with psychiatric indication for hospitalization
2. patients with psychiatric comorbidity
3. patients with a diagnosis of personality disorder
4. presence of severe neurological or medical diseases such as neoplasms in activity, neurodegenerative diseases and chronic diseases uncompensated.

Primary outcomes:
measure: • Hamilton Depressive Rating Scale version 17 items (HDRS-17)
timeFrame: Change from baseline in depressive symptoms at 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Trevizol AP, Sato IA, Bonadia B, Liquidato BM, Barros MD, Cordeiro Q, Shiozawa P. Trigeminal Nerve Stimulation (TNS) for Major Depressive Disorder in Pregnancy: A Case Study. Brain Stimul. 2015 Sep-Oct;8(5):988-9. doi: 10.1016/j.brs.2015.07.034. Epub 2015 Jul 23. No abstract available.
citation: Shiozawa P, Duailibi MS, da Silva ME, Cordeiro Q. Trigeminal nerve stimulation (TNS) protocol for treating major depression: an open-label proof-of-concept trial. Epilepsy Behav. 2014 Oct;39:6-9. doi: 10.1016/j.yebeh.2014.07.021. Epub 2014 Aug 23.
citation: Cook IA, Schrader LM, Degiorgio CM, Miller PR, Maremont ER, Leuchter AF. Trigeminal nerve stimulation in major depressive disorder: acute outcomes in an open pilot study. Epilepsy Behav. 2013 Aug;28(2):221-6. doi: 10.1016/j.yebeh.2013.05.008. Epub 2013 Jun 14.
Clinical trial NCT05395403: Use of Automated Office Blood Pressure Monitoring
Official title: Use of Automated Office Blood Pressure Monitoring in Older Working-age Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Uncontrolled Hypertension
Hypertension, White Coat
Hypertension, Resistant to Conventional Therapy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Troy University
First posted: 2022-05-27
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Blood pressure measurements by three methods Office Blood Pressure Measurement (OBPM), Automated Office Blood Pressure Measurement (AOBPM), and Home Blood Pressure Measurement (HBPM) were collected retrospectively across three visits for patients (N=28) referred to a specialty hypertension (HTN) clinic. Demographic data were analyzed using summary statistics. The differences between AOBPM, HBPM, and OBPM were examined using mixed models repeated measures analysis for time and method for each visit.


Eligibility criteria: Inclusion Criteria:

* 19 years and older
* Uncontrolled BP
* Prescribed three or more antihypertensive medications at the time of referral
* Higher risk for poor CV outcomes than patients with essential HTN
* OBPM systolic BP of greater than 140 mmHg and diastolic BP of greater than or equal to 90 mm Hg upon initial clinic assessment.

Exclusion Criteria:

* Less than 19 years old
* Had a systolic BP of less than 140 mm Hg and diastolic BP of less than 90 mmHg upon initial clinic assessment.
* Also, patients on less than three antihypertensive medications, with less than three visits, and who have controlled OBPM were excluded.

Primary outcomes:
measure: Number of participants using Traditional office blood pressure measurement (OBPM)
timeFrame: Baseline
measure: Number of participants using Traditional office blood pressure measurement (OBPM)
timeFrame: Up to 8 weeks
measure: Number of participants using Traditional office blood pressure measurement (OBPM)
timeFrame: Up to 16 weeks
measure: Number of participants using Automated office blood pressure measurement (AOBPM)
timeFrame: Baseline
measure: Number of participants using Automated office blood pressure measurement (AOBPM)
timeFrame: Up to 8 weeks
measure: Number of participants using Automated office blood pressure measurement (AOBPM)
timeFrame: Up to 16 weeks
measure: Number of participants using Home blood pressure measurement (HBPM)
timeFrame: Baseline
measure: Number of participants using Home blood pressure measurement (HBPM)
timeFrame: Up to 8 weeks
measure: Number of participants using Home blood pressure measurement (HBPM)
timeFrame: Up to 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
Clinical trial NCT00218803: Teaching Children With Asthma and Who Live in a Rural Setting How to Self-Manage Their Asthma
Official title: A+ Asthma Rural Partnership
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: National Institute of Nursing Research (NINR)
Sponsor class: NIH
First posted: 2005-09-22
Enrollment: 220
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To determine if teaching rural children with asthma and their parents about appropriate medication use, asthma triggers unique to a rural setting and increasing access to medical care will result in a decrease in emergency department visits.

Detailed description: Many self-management asthma interventions have demonstrated increase in asthma knowledge, reduced emergency department visits, increased self-efficacy and quality of life. The type of self-management interventions, specifically individualized and interactive educational interventions, have been suggested to have the strongest effect on asthma morbidity. Few studies have tested asthma self-management educational interventions in increasing knowledge, self-efficacy and quality of life in rural pediatric populations. The goal of this study was to test the effectiveness of an asthma educational intervention in improving asthma knowledge in rural children and their parent/caregivers. We hypothesized that an interactive asthma educational intervention would increase parent/caregiver and child asthma knowledge resulting in decreased emergency room visits in rural families of children with asthma.

Eligibility criteria: Inclusion Criteria:

* Physician diagnosed asthma, attend elementary school in rural county agreeing to participate

Exclusion Criteria: Participation in another asthma study or having other respiratory illness such as cystic fibrosis, BPD

-

Primary outcomes:
measure: Decrease in emergency department visits
timeFrame: 10 months or 1 school year
Secondary outcomes:
measure: Asthma Education
timeFrame: 10 months or 1 school year
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Arlene M Butz, SCD,MSN,BSN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Naumann PL, Huss K, Calabrese B, Smith T, Quartey R, Van de Castle B, Lewis C, Hill K, Walker J, Winkelstein M. A+ Asthma Rural Partnership coloring for health: an innovative rural asthma teaching strategy. Pediatr Nurs. 2004 Nov-Dec;30(6):490-4.