louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03316612: The Effect of Vaccinium Myrtillus L. Extract Intake on Human Metabolism
Official title: The Effect of Vaccinium Myrtillus L. Extract Intake on Human Metabolism: A Randomized Double-Blind Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Advanced Glycation End Products, Metabolites, Gut Microbiota
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Advanced glycation end-products (AGEs) has been linked to ageing, and many metabolic diseases. The findings of previous experiments suggested that the extracts from polyphenol-rich bilberry might inhibit the formation of AGEs. This is a randomized double-blind trial, aims to study the effect of Vaccinium Myrtillus L. natural extracts on AGEs and human metabolism. Firstly, we will investigate the efficacy of Bilberry extracts on lowering the levels of advanced glycation end-products (AGEs). Secondly, we will conduct 16S rRNA sequencing and ultra-high performance liquid chromatography-tandem mass spectrometric (UPLC-MS/MS) detection to explore the role of bilberry extracts on gut microbiota as well as metabolites.


Eligibility criteria: Inclusion Criteria:

* Aged between 18-35 years of age
* Able to give informed connect

Exclusion Criteria:

* Pregnancy
* Known cardiovascular disease (stroke, ischemic heart disease and so on), diabetes, hypertension and any other chronic disease.
* Known gastrointestinal disease, such as Irritable Bowel Syndrome(IBS), functional bowel disease and so on.
* Evidence of drug or alcohol abuse

Primary outcomes:
measure: Changes in plasma AGEs levels
timeFrame: At 0 week (baseline), 4th week, 10th week.
measure: Changes in urinary AGEs levels
timeFrame: At 0 week (baseline), 4th week, 10th week.
measure: Changes in plasma sRAGE levels
timeFrame: At 0 week (baseline), 4th week, 10th week.
measure: Changes in transcription levels of RAGE and AGER1
timeFrame: At 0 week (baseline), 4th week, 10th week.
measure: Changes in gut microbiota
timeFrame: At 0 week (baseline), 10th week.
measure: Changes in plasma metabolites
timeFrame: At 0 week (baseline), 4th week, 10th week.
Secondary outcomes:
measure: Changes in skin AGEs levels
timeFrame: At 0 week (baseline), 4th week, 10th week.
measure: Changes in body weight
timeFrame: At 0 week (baseline), 4th week, 10th week.
measure: Change in body composition (body fat mass and lean mass)
timeFrame: At 0 week (baseline), 4th week, 10th week.
measure: Changes in blood lipids profile
timeFrame: At 0 week (baseline), 4th week, 10th week.
measure: Changes in pro-inflammatory markers
timeFrame: At 0 week (baseline), 4th week, 10th week.
measure: Changes in fecal short chain fatty acids (SCFA)
timeFrame: At 0 week (baseline), 10th week.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT04325412: Cardiac complicAtions in Patients With SARS Corona vIrus 2 (COVID-19) regisTrY
Official title: Cardiac complicAtions in Patients With SARS Corona vIrus 2 regisTrY
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19; Cardiovascular Diseases
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients were admitted at one of the participating centres with highly suspected/confirmed infection with SARS-CoV-2.

Brief summary: CAPACITY (www.capacity-covid.eu) is a registry of patients with COVID-19 across Europe and has been established to answer questions on the role of cardiovascular disease in this pandemic. It is an extension of the Case Record Form (CRF) that was released by the ISARIC (International Severe Acute Respiratory and Emerging Infection Consortium) and WHO (World Health Organisation) in response to the emerging outbreak of COVID-19.

Detailed description: The aim of CAPACITY is to collect data regarding the cardiovascular history, diagnostic information and occurrence of cardiovascular complications in COVID-19 patients. By collecting this information in a standardized manner, CAPACITY can aid in providing more insight in (1) the incidence of cardiovascular complications in patients with COVID-19, and (2) the vulnerability and clinical course of COVID-19 in patients with an underlying cardiovascular disease.

The CAPACITY extension to the ISARIC-WHO CRF consists of additional data collection instruments for:

* cardiac history and cardiovascular risk factors
* prior use of cardiac medication or NSAIDs
* electrocardiography (ECG)
* echocardiography
* cardiac MRI
* invasive cardiac procedures
* cardiac complications
* cardiac biomarkers
* cardiac outcome during admission

Eligibility criteria: Inclusion Criteria:

* Highly suspected/confirmed infection with SARS-CoV-2

Exclusion Criteria:

- Patients that opt-out

Primary outcomes:
measure: The incidence of cardiovascular complications in patients with COVID-19
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
References:
citation: Henkens MTHM, Raafs AG, Verdonschot JAJ, Linschoten M, van Smeden M, Wang P, van der Hooft BHM, Tieleman R, Janssen MLF, Ter Bekke RMA, Hazebroek MR, van der Horst ICC, Asselbergs FW, Magdelijns FJH, Heymans SRB; CAPACITY-COVID collaborative consortium. Age is the main determinant of COVID-19 related in-hospital mortality with minimal impact of pre-existing comorbidities, a retrospective cohort study. BMC Geriatr. 2022 Mar 5;22(1):184. doi: 10.1186/s12877-021-02673-1.
Clinical trial NCT01794312: Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer
Official title: Efficacy and Safety Assessment of T4020 Versus Vehicule in Patients With Chronic Neurotrophic Keratitis or Corneal Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Keratitis
Corneal Ulcer
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2013-02-18
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of T4020 versus vehicle.


Eligibility criteria: Inclusion Criteria:

* Adult patients diagnosed with one chronic keratitis/corneal ulcer
* Patients who signed and dated informed consent

Exclusion Criteria:

* Patient under 18 years
* Patient with a perforated corneal ulcer OR any risk of immediate perforation of corneal ulcer.

Primary outcomes:
measure: Number of Participants With a Reduction in Neurotrophic the Keratitis/Ulcer Area on Day28
timeFrame: Day 28
Secondary outcomes:
measure: Number of Participants With at Least One Treatment-emergent Adverse Event
timeFrame: From the first visit to the final visit performed by the patient + 1 month later, assessed up to 71 days
measure: Best Corrected Visual Acuity
timeFrame: Baseline and Day 28
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Clinical Development Director
Study officials:
References:
Clinical trial NCT04221412: Pre-Approval Access to JNJ-53718678 for the Treatment of Respiratory Syncytial Virus (RSV) Infection in (a) Immunocompromised Adult and Pediatric Participants
Official title: JNJ-53718678 RSV Pre-Approval Access_Single Patient Access (SPR) for Patients Diagnosed With RSV
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Respiratory Syncytial Virus
Lead sponsor: Janssen Sciences Ireland UC
Sponsor class: INDUSTRY
First posted: 2020-01-09
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this pre-approval access program is to provide treatment to immunocompromised participants with serious/life-threatening diseases or conditions (Respiratory Syncytial Virus \[RSV\] infection) and to collect the safety data to understand the safety profile of JNJ-53718678.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT02011412: Intermountain Risk Score and Trauma
Official title: The Intermountain Risk Score's Association With Mortality Prediction in Trauma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Injury
Keywords: Trauma
Scoring Systems
Intermountain Risk Score
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2013-12-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who suffer from a traumatic injury and present to the Emergency Department as a Trauma Activation

Brief summary: The investigators hypothesize that a risk score composed of age, sex, and the components of commonly ordered laboratory panels will be predictive of mortality in trauma patients, and will help improve clinicians' ability to make more accurate mortality predictions at the time of admission.


Eligibility criteria: Inclusion Criteria:

* Patient presents to Intermountain Medical Center as a Level I or Level II trauma activation.
* Age ≥18

Exclusion Criteria:

* Patients who are not admitted to the hospital

  1. Patients who expire in the Emergency Department
  2. Patients who are discharged to home from the Emergency Department
* Patients who do not have a complete blood count and basic metabolic profile drawn in the Emergency Department as part of routine clinical care.
* Patients who enter the hospital as "trauma consults." These patients have traumatic injuries, and are often admitted to the trauma service, but the severity of their trauma is not thought to warrant trauma team activation.

Primary outcomes:
measure: all cause mortality
timeFrame: 30 days
measure: all cause mortality
timeFrame: 1 year
Secondary outcomes:
measure: experienced clinicians mortality prediction
timeFrame: 30 days
measure: Experienced Clinicians' mortality prediction
timeFrame: 1 year
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
References:
Clinical trial NCT01078012: Short Intervention for Medication Overuse Headache (MOH) - Pilot
Official title: Pilot Study of Short Intervention for Medication Overuse Headache in General Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Overuse Headache
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Department of General Practice and Community Medicine, Oslo
name: Head and Neck Research Group, Lørenskog
First posted: 2010-03-02
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is together with the BIMOH (NCT01314768) RCT study to evaluate whether training of GPs in the detection and treatment of medication overuse headache leads to improved care for these patients as compared to "business as usual".

Detailed description: The present pilot study focuses on testing the logistics and the methodology of short intervention on a pilot group of GPs and their patients.

Due to low recruitment and the pilot study focus on logistics and methodology, the study was changed to not include a control (business as usual) arm. The outcomes were evaluated as "before - after" data and qualitative comments on acceptability and utility of the method. Primary outcomes were changed to be the acceptability and utility (previously listed as secondary outcomes) while secondary outcomes were headache days and medication days (previously listed as primary).

Eligibility criteria: Inclusion Criteria:

* Diagnosed with medication overuse headache

Exclusion Criteria:

* Other complicating pain condition

Primary outcomes:
measure: Qualitative comments of participants on acceptability and utility
timeFrame: 2 months
Secondary outcomes:
measure: Qualitative comments of participants on acceptability and utility.
timeFrame: 2 months
measure: Number of medication days per month
timeFrame: 2 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Department of General Practice and Community Medicine
Study officials:
References:
citation: Kristoffersen ES, Straand J, Russell MB, Lundqvist C. Feasibility of a brief intervention for medication-overuse headache in primary care--a pilot study. BMC Res Notes. 2014 Mar 20;7:165. doi: 10.1186/1756-0500-7-165.
Clinical trial NCT00910312: ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial
Official title: Evaluation of Safety and Feasibility of the ICE-SENSE™, a Cryotherapy Device for Office-based Ultrasound-guided Treatment of Breast Fibroadenoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibroadenoma
Lead sponsor: IceCure Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2009-05-29
Enrollment: 54
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: The purpose of this study is to determine whether the Ice-Sense, a novel cryotherapy system (a system that freezes tissues), is safe and effective in the treatment of benign breast tumors such as fibroadenoma.


Eligibility criteria: Inclusion Criteria:

* Patient is above 18 years old.
* Patient has breast fibroadenoma, proven by biopsy (Core Biopsy).
* Patient's fibroadenoma can be visualized with ultrasound.
* Patient's fibroadenoma size is between 0.5cm and 3cm at its largest dimension.
* Patient is able to visit the clinic as needed during the 12-month follow-up period following the cryoablation procedure.
* The patient has been informed of the study and agrees to its provisions, and has signed an IRB/EC approved written informed consent, including data privacy authorization.

Exclusion Criteria:

* Patients with history of breast cancer.
* Women with known pregnancy.
* Patients with superficial fibroadenoma very close to the skin.
* Patient has undergone major surgery within the previous 12 weeks.
* Patients with any terminal illness, or with a life expectancy \<2 year.
* Patients carrying contagious diseases such as Tuberculosis Hepatitis or AIDS.
* Patient participating in other trials using drugs or devices.

Primary outcomes:
measure: engulfment of the tumor by the ice-ball as seen under ultrasound imaging
timeFrame: during the procedure
Secondary outcomes:
measure: any device related adverse events or complications that may occur
timeFrame: one year
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Oncogynecological Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague
city: Heidelberg
country: Germany
facility: Department of Obstetrics and Gynecology, University Hospital of Heidelberg
city: Tübingen
country: Germany
facility: Department of Obstetrics and Gynecology, University Hospital of Tuebingen
city: Haifa
country: Israel
facility: Assuta medical centers
Study officials:
name: Rafi Klein, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05868512: Effectiveness of DN Versus TU Along With Routine PT in Patients With for Chronic Neck Pain RCT
Official title: Effectiveness of Dry Needling Versus Therapeutic Ultrasound Along With Routine Physical Therapy in Patients With for Chronic Neck Pain; a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determine the effectiveness of dry needling and therapeutic ultrasound for the treatment of chronic neck pain


Eligibility criteria: Inclusion Criteria:

* The inclusion criteria will be office workers having pain sensation at neck for at least 4 months
* pain for 3-7 on NRS and with the limited or painful ROM.
* Age of the participants will be 20-35 years.
* Only those individuals will be included who are working in the field for more than 8 months and work for 6-8 hours per day.

Exclusion Criteria:

* The exclusion criteria were any other neurological conditions of cervical vertebra, cervical radiculopathy, any vascular disease, tumors or any other local infection

Primary outcomes:
measure: Range of Motion Scale
timeFrame: 3 Months
measure: Visual Analog Scale for pain the lower score is better
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Households
state: Punjab
Study officials:
References:
Clinical trial NCT02970812: Effects of Electrical Muscle Stimulation on Waist Circumference in Adults
Official title: Effects of Electrical Muscle Stimulation on Waist Circumference in Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Obesity
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized, placebo-controlled, double-blind, controlled study was designed to investigate the efficacy of electrical muscle simulation (EMS) for treatment of waist circumference (WC) reduction in abdominal obese adults.

60 patients with abdominal obese, man with WC \> 90 cm and woman with WC \> 80 cm, received EMS as experimental group (EG) or transcutaneous electrical nerve stimulation (TENS) as control group (CG) 5 times a week for 12 weeks.

Detailed description: Background: This randomized, placebo-controlled, double-blind, controlled study was designed to investigate the efficacy of electrical muscle simulation (EMS) for treatment of waist circumference (WC) reduction in abdominal obese adults.

Methods: 60 patients with abdominal obese, man with WC \> 90 cm and woman with WC \> 80 cm, received EMS as experimental group (EG) or transcutaneous electrical nerve stimulation (TENS) as control group (CG) 5 times a week for 12 weeks.

Eligibility criteria: Inclusion Criteria:

* Subject has abdominal obese seventy subjects between the age 18 and 65 years
* Abdominal obesity was defined as having a waist circumference (WC) \>90 cm for men or WC \>80 cm for women was defined based on the Asia-Pacific criteria of the International Diabetes Federation.

Exclusion Criteria:

* pregnant or breastfeeding, had taken any treatment for weight loss or any medication known to affect weight
* had a weight loss of 3% or more in the preceding 3 months, had undergone any major surgery during the 1 year prior to study commencement
* had any inserted metallic materials including a pacemaker.
* aspartate aminotransferase or alanine aminotransferase of 100 mg/dL or more
* serum creatinine of 1.5 mg/dL or more
* a history of coronary arterial disease or cerebrovascular disease, impairment of a major organ system, cancer, severe lung diseases, severe cerebral trauma, uncontrolled hypertension and psychiatric diseases including eating disorder, etc.

Primary outcomes:
measure: Waist Circumference
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
state: Gyeungsangnam-do
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01867112: Physical Activity for Improving Quality of Life and Reducing Frailty in Advanced Age
Official title: Physical Activity for Improving Quality of Life and Reducing Frailty in Advanced Age: Individually Tailored Program vs the General Guidelines Recommended by Offical Health Organizations.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aging
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-06-03
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Individuals of advanced age undergo both physical and cognitive deterioration. The aim of this study is to explore the connection between level of physical activity and health parameters, quality of life, and frailty.


Eligibility criteria: Inclusion Criteria:

* Age above 65
* Able to undergo graded stress exam

Exclusion Criteria:

* All others

Primary outcomes:
measure: Aerobic Fitness
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Wingate
country: Israel
facility: Zinman College for Physical Education and Sport Sciences
Study officials:
References: