louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04225091: Efficacy Evaluation of Triple up® Collagen Drink on Skin Condition
Official title: Efficacy Evaluation of Triple up® Collagen Drink on Skin Condition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Condition
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-13
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess Triple up® Collagen Drink on skin condition improvement


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged above 20 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history).
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.
* Vegetarian
* Subjects who have large spots (area \>3 square centimeter) or abnormal acne.

Primary outcomes:
measure: The change of skin moisture
timeFrame: Change from Baseline skin moisture at 4 weeks
measure: The change of skin elasticity
timeFrame: Change from Baseline skin elasticity at 4 weeks
measure: The change of skin wrinkles
timeFrame: Change from Baseline skin wrinkles at 4 weeks
measure: The change of skin collagen density
timeFrame: Change from Baseline skin collagen density at 4 weeks
Secondary outcomes:
measure: The change of skin texture
timeFrame: Change from Baseline skin texture at 4 weeks
measure: The change of skin pores
timeFrame: Change from Baseline skin pores at 4 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Chia Nan University of Pharmacy ＆ Science
Study officials:
affiliation: Chia Nan University of Pharmacy ＆ Science
name: Chia-Hua Liang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03381391: Adapting a Secondary Prevention Program for Nonstudent Emerging Adult Drinkers
Official title: Adapting a Secondary Prevention Program for Nonstudent Emerging Adult Drinkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Lead sponsor: Old Dominion University
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Emerging adulthood is a period of heightened vulnerability for problematic alcohol use. Considerable research has been devoted to reducing alcohol risks in college student populations, though far less effort has focused on their noncollege-attending peers. Research targeting nonstudent emerging adults is critical as this group is at risk for experiencing alcohol-related harms. Consequently, the main objective of the present study was to examine the preliminary efficacy of a brief personalized feedback intervention (PFI) tailored for nonstudent at-risk drinkers.


Eligibility criteria: Inclusion Criteria:

* Study eligibility included being 18 to 25 years old, having no prior or current college attendance (e.g., technical/vocational programs, associate's degree programs, or four year college programs), and not being currently enrolled in high school. High school completion was not a required eligibility criteria. They also had to report engaging in a minimum of two heavy drinking episodes (i.e., 4/5+ standard drinks for women/men on one occasion) in the past month

Exclusion Criteria:

* Exclusion criteria included consumption above 40 drinks weekly and/or a history of substance use treatment

Primary outcomes:
measure: Alcohol use quantity
timeFrame: 9 months
measure: Alcohol-related harms
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01479491: Study on the Incidence of Intussusception (IS) in Children Aged < 12 Months in Japan
Official title: Observational Database Study on the Incidence of Intussusception in Children Aged < 12 Months in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intussusception
Keywords: Japan
Retrospective
Observational
Epidemiological study
Children aged < 12 months
Intussusception
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-11-24
Enrollment: 54
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged \<12 months presenting with IS and covered by the JMDC-MDB database from January 2005 to April 2011.

Brief summary: This study aims to analyse baseline data on IS in order to monitor the possibility of increased risk of IS in children aged \<12 months after introduction of the Rotarix vaccination in Japan.


Eligibility criteria: Inclusion Criteria:

* A male or female infant aged \< 12 months at the time of IS diagnosis and affiliated to the JMDC-MDB database.
* An IS case should be identified as per the ICD-10 diagnostic code-K56.1 (any-field listed), examination codes, and procedural codes.

Exclusion Criteria:

Not applicable

Primary outcomes:
measure: Occurrence of IS in subjects aged < 12 months
timeFrame: Between January 2005 and April 2011 (6 years)
measure: Occurrence of age-specific and gender-specific incidence of IS among subjects aged < 12 months in Japan
timeFrame: Between January 2005 and April 2011 (6 years)
Secondary outcomes:
measure: Number of IS cases hospitalized more than once among subjects aged < 12 months.
timeFrame: Between January 2005 and April 2011 (6 years)
measure: Occurrence of IS cases by calendar months and year among subjects aged < 12 months
timeFrame: Between January 2005 and April 2011 (6 years)
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04971291: An Evaluation of AXS-05 for the Treatment of TRD in Treatment-Adherent Patients
Official title: A Randomized, Active-Controlled, Evaluation of AXS-05 for the Treatment of Treatment Resistant Depression in Treatment-Adherent Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Major Depressive Disorder
Treatment Resistant Depression
Keywords: AXS-05
Axsome
NMDA receptor
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-21
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The TARGET study is an active-controlled evaluation of AXS-05 compared to bupropion in patients with treatment-resistant major depressive disorder (MDD) who are adherent to study drug. Subjects are considered to have treatment-resistant MDD if they have had a historical inadequate response to 1 or 2 prior antidepressant treatments (ADTs) and a prospective inadequate response to treatment with bupropion SR, during the current major depressive episode.

The TARGET study will first determine treatment adherence based on analysis of drug concentrations of dextromethorphan (in the AXS-05 group) and bupropion (in the bupropion group), and then evaluate the efficacy of AXS-05 in patients determined to be treatment-adherent. Efficacy data for evaluation of treatment effect will be obtained from assessments made during study AXS-05-301.


Eligibility criteria: Key Inclusion Criteria:

* Provided written informed consent to participate in Study AXS-05-301
* Has treatment-resistant depression, defined as an inadequate response to 2 or 3 prior ADTs
* Body mass index (BMI) between 18 and 40 kg/m2, inclusive

Key Exclusion Criteria:

* Suicide risk
* Treatment with any investigational drug within 6 months
* History of electroconvulsive therapy (ECT), vagus nerve stimulation, transcranial magnetic stimulation, or any experimental central nervous system treatment during the current episode or in the past 6 months
* Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS) total score
timeFrame: Change from Baseline to Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Axsome Research Site
state: New York
Study officials:
References:
Clinical trial NCT03720691: rTMS Treatment in Vascular Parkinsonism
Official title: Effect of Repetitive Transcranial Magnetic Stimulation in Vascular Parkinsonism
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vascular Parkinsonism
Keywords: parkinsonism
vascular parkinsonism
repetitive transcranial magnetic stimulation
brain stimulation
Lead sponsor: Inje University
Sponsor class: OTHER
Collaborators: name: Dongtan Sacred Heart Hospital
First posted: 2018-10-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vascular parkinsonism (VP), parkinsonism resulting from ischemic cerebrovascular disease, was suggested in 1929. The main features are wide-based gait, postural instability, and falls, which make patients with VP frustrated. Currently, the treatment is challenging.

Transcranial magnetic stiumation is a noninvasive procedure using electromagnetic induction to stimulate brain, and repetitive transcranial magnetic stiumation (rTMS) can selectively change brain activity to enhance desired effects. The aim of this study is to explore the therapeutic effect of rTMS for the VP.


Eligibility criteria: Inclusion Criteria:

* Vascular parkinsonism
* age 18 and older

Exclusion Criteria:

* pregnant or any, other medical, surgical, neurological or psychiatric conditions
* other restrictions which prevent you from undergoing TMS recording, such as; surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), and/ or heart/cardiac lines
* any past or current history of seizure disorder or epilepsy
* unable to give informed consent

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale (UPDRS) part III-motor part (Number 18 ~31 of UPDRS)
timeFrame: 2 days
Secondary outcomes:
measure: Finger tapping test with right hand
timeFrame: 2 days
measure: The total number of steps during the stand-walk-sit (SWS) test
timeFrame: 2 days
measure: The completion time during the SWS test
timeFrame: 2 days
measure: Freezing episodes of gait trajectory
timeFrame: 2 days
measure: Patient and Clinical Global Impression Scale
timeFrame: 2 days
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje university, Busan Paik Hospital
Study officials:
affiliation: Inje Unversity, Busan Paik Hospital
name: Sang Jin Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02121691: Faith-Based Initiative to Promote Health in Appalachia
Official title: Appalachia Community Cancer Network II Centers for Reducing Cancer Disparities: Faith-Based Initiative to Promote Health in Appalachia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Obesity
Keywords: Cancer
Obesity
Body Mass Index
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2014-04-23
Enrollment: 669
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The project will target two behavioral causes of obesity: a sedentary lifestyle and an unhealthy diet. The goal is to test a faith-based intervention among men and women who are members of participating Appalachian churches.

The primary hypothesis being tested in this project is: The change in body mass index from baseline to one year follow-up in intervention churches will be greater than among comparison churches, such that the differential change will be negative on average.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Member of the participating church who has attended services at least 4 times in the past 2 months
* resident of an Appalachia county
* Able bodied (no contraindications to physical activity and no dietary restrictions that are part of a medically prescribed diet for weight loss or formal weight loss program)
* Able to read and write in English
* Have a BMI indicating that they are overweight (BMI \> or = 25.0, assessed during biometric measurement)
* Under 400 pounds (per self-report and confirmed during biometric measurement)
* Not planning to move out of the area within the next year
* Does not reside in nursing facility or residential home
* If female, is not pregnant, breastfeeding or less than 9 months post-partum and does not intend to become pregnant during the study
* Able to provide informed consent.

Exclusion Criteria:

* Does not meet Inclusion criteria

Primary outcomes:
measure: Change in body mass index from baseline to one year follow-up
timeFrame: Baseline, month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Markey Cancer Center
state: Kentucky
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
city: Blacksburg
country: United States
facility: Virginia Tech
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Lucille P. Markey Cancer Center at University of Kentucky
name: Mark Dignan, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04520191: Home-based Kidney Care in Native Americans of New Mexico (HBKC) - Enhancement: COVID-19 Study
Official title: Home-based Kidney Care in Native Americans of New Mexico (HBKC) - COVID-19 Related Disruption in Health and Health Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CKD
Keywords: CKD, Diabetes, Ameircan Indians, COVID-19,
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 309
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Native Americans (n=529) who participated in the screening for diabetes and kidney disease as part of original HBKC study will be approached for this survey based study.

Brief summary: Novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) OR COVID-19 related Addition: The aim of this addition activity is to track the impact of the COVID-19 epidemic on participants with diabetes and chronic kidney disease (CKD). Investigators have modified the original HBKC Study protocol to expand data currently collected from study participants to include data in the following domains linked to the COVID-19 epidemic:

symptoms of COVID-19 disease, access to healthcare, and impact on health related behaviors (such as medication adherence, physical activity, dietary behaviors, smoking, and alcohol use).

Detailed description: Investigators will administer a survey by phone or mail to all participants screened for diabetes and chronic kidney disease in the original HBKC study protocol. The survey will address to the following aims:

Aim 1. Develop a phone-based and or mail based survey to understand the impact of COVID19 on patient-reported outcomes for adults with diabetes and CKD.

Aim 2. Test the feasibility and acceptability of this phone-based and or mail based survey in the HBKC cohort.

Eligibility criteria: Inclusion Criteria:

* Willingness to participate in the phone-based and or mail based survey.

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Participants With Problems in Their Health Care Due to COVID-19 Related Isolation
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
References:
Clinical trial NCT05453591: Investigation of Urinary Biomarkers for the Detection of Breast Cancer
Official title: Investigation of Urinary Biomarkers for the Detection of Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Urine
Liquid Biopsy
Keywords: First-void urine
Liquid biopsy
Oncology
Colli-Pee
Biomarker
Lead sponsor: Novosanis NV
Sponsor class: INDUSTRY
Collaborators: name: Universiteit Antwerpen
First posted: 2022-07-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to investigate and possibly validate urinary biomarkers for breast cancer. During this study the focus will be on aberrations of selected genes as prognostic or predictive value has been shown for these genes in tissue, CTC or blood derived cfDNA. Proteins will be explored in urine as well.

This is a prospective study in which urine samples will be collected from healthy volunteers and urine samples and a blood sample from cancer patients with breast cancer. The participants will be asked to provide a urine sample collected with the ColliPee® device and fill out an online questionnaire to collect usability data. Thereafter, the urine sample will be aliquoted to be used in the study to investigate the different urinary analytes.


Eligibility criteria: Inclusion Criteria:

* Being at least 18 years old
* Being able to understand and read Dutch
* For cancer patients: diagnosed with breast cancer

Exclusion Criteria:

* For cancer patients: suffering from a blood cancer
* For healthy volunteers: diagnosed with cancer

Primary outcomes:
measure: Detection (presence/absence) of specific urinary biomarker targets (HER2, PIK3CA) for breast cancer patients measured using ddPCR.
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Detection (presence/absence) of specific biomarker targets (HER2, PIK3CA) for breast cancer patients measured using ddPCR.
timeFrame: Through study completion, an average of 1 year
measure: Usability characteristics of the Colli-Pee UAS devices.
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Universitair ziekenhuis Antwerpen
state: Antwerpen
Study officials:
References:
Clinical trial NCT06227091: The Effect od Beetroot Juice on Forearm Muscle Strength and Muscle EMG Activity After BloodFlow Restriction
Official title: Analysis of Electromyography Activation Trunk Muscles and the Effect of Beetroot Juice Intake on the Results in Strength Exercises: Lateral Medicine Ball Throw and Sled Pushing
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Muscle Strength
Lead sponsor: Poznan University of Physical Education
Sponsor class: OTHER
First posted: 2024-01-26
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The primary aim of the current study is determine the effect of beetroot juice consumption on maximal grip strength and EMG muscle activity

Detailed description: In random order subjects will consume high nitrate beetroot juice or low level of nitrate beetroot juice. Grip strength and EMG will be measured at the beginning and repeated after 2h.

Using blood pressure cuff, occlusion will be induced to restrict blood flow in the brachial artery. Following the deflation of the cuff, assessments will be conducted for grip strength and electromyography (EMG) activation of the forearm muscles. These measurements will be taken both initially and after a 2-hour interval.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

-

Primary outcomes:
measure: The effect of Beetroot Juice consumption on Grip Strength
timeFrame: 2 hours
Secondary outcomes:
measure: The effect of Beetroot Juice consumption on EMG muscle activity
timeFrame: 2 hours
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Akademia Wychowania Fizycznego
city: Poznań
country: Poland
facility: Akademia Wychowania Fizycznego
Study officials:
affiliation: Poznan University of Physical Education
name: Robert Olek, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02891291: Optical Tomographic Scanner for Skin Lesions
Official title: Optical Tomographic Scanner for Skin Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Skin Cancer, Benign Skin Tumor, Inflammatory Skin Disease
Keywords: optical coherence tomography
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2016-09-07
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient's age are between 20 to 100 years old. Patients who receive skin biopsy or surgery at Department of Dermatology, National Taiwan University Hospital, Taiwan.

Brief summary: Optical coherence tomography is technology widely used in medicine. In this study, the investigators will use an optical tomographic scanner to scan skin tissue image.

Detailed description: The investigators will use optical tomographic scanner to scan skin specimen and obtain tissue images. Part of skin specimen obtained from skin biopsy or surgery will be scanned.

Eligibility criteria: Patient who receive skin biopsy or surgery due to skin cancers, benign skin diseases, or inflammatory skin diseases.

Primary outcomes:
measure: Skin tissue image obtained.
timeFrame: 1 week
Secondary outcomes:
measure: Skin histopathology
timeFrame: 2 week
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: NTUH
name: JENGWEI TJIU, MDPHD
role: PRINCIPAL_INVESTIGATOR
References: