louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01344694: Epicardial Fat, Visceral Fat and Coronary Atherosclerosis
Official title: Association Between Epicardial Fat, Visceral Fat Accumulation & Cardiovascular Atherosclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Epicardial Fat
Visceral Fat
Atherosclerosis
Keywords: Epicardial fat
Visceral fat
atherosclerosis
coronary computed tomography angiography
Carotid Doppler ultrasound
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2011-04-29
Enrollment: 110
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50 patients (age 40-70) with excess of visceral fat (obese), 30 patient with liver fat and 30 sexes, age matched individuals will be recruited.

Brief summary: Background: Visceral fat is increasingly associated with metabolic syndrome and with fatty liver, a condition carrying a high risk of cardiovascular disease. The independent role of epicardial fat deposition in cardiovascular risk remains unclear.

Detailed description: Background: Visceral fat is increasingly associated with metabolic syndrome and with fatty liver, a condition carrying a high risk of cardiovascular disease. The independent role of epicardial fat deposition in cardiovascular risk remains unclear. Aim: Evaluate the link between epicardial fat, visceral fat, liver fat accumulation and cardiovascular diseases and carotis atherosclerosis in patients with the major cardiovascular risk factors and with or without metabolic syndrome.

Eligibility criteria: Inclusion Criteria:

* Patients referred to cardiac CT will be the source of recruitment.
* patients with excess of visceral fat,
* 30 patients with liver fat accumulation
* 30 sex-age-matched individual (controls) will be enrolled. All patients will undergo a complete family history, personal clinical history, physical examination and blood sampling for biochemical analysis.
* Informed consent will be obtained from each individual.

Exclusion Criteria:

* subjects with severe morbid obesity (body mass index \[BMI\] \> 40),
* recent history of acute illness,
* clinical history of ischemic heart disease and cerebrovascular disease,
* typical chest pain,
* previous coronary artery disease,
* conventional coronary angiography, percutaneous interventions, coronary by pass grafting, renal failure, cancer patients,
* subjects who take drugs that induces hepatic steatosis ( corticosteroids, estrogens, methotrexate, amiodarone and others)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Ziv MC
Study officials:
affiliation: Ziv MC
name: Nimer Assy, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03484091: Comparison of Single Intra-articular Injection of Hyruan-One With Hylan G-F 20 in Knee Osteoarthritis
Official title: Comparison of Single Intra-articular Injection of Hyruan-One With Hylan G-F 20 in Knee Osteoarthritis: A Randomized Double-blind, Saline-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: Hyruan-One
Hylan G-F 20
Hyaluronic acid
Knee osteoarthritis
Pain level
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2018-03-30
Enrollment: 276
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double-blind, placebo controlled RCT
Primary purpose: TREATMENT

Brief summary: We compare the efficacy of intra-articular injection of Hyruan-One with Hylan G-F 20 and placebo (NSS) controlled in a double-blind RCT.


Eligibility criteria: Inclusion Criteria:

* Symptomatic primary knee osteoarthritis with failed conservative treatment at least 3 months
* Kellgren-Lawrence grade I-III
* Gave informed consent
* Can do questionnaires

Exclusion Criteria:

* Severe deformity (varus or values from mechanical axis more than 5 degrees
* Allergy to hyaluronic acid
* Pain on hip or ankle
* Post-traumatic or post surgery of lower extremity
* Post infection of knee
* Previous hyaluronic acid injection within 6 months
* Pregnancy or lactation
* Underlying Rheumatoid arthritis, stroke, malignancy, venous occlusion

Primary outcomes:
measure: Pain level
timeFrame: 6 months after injection
measure: Change from pre-injection pain level at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: pain level in any time pints
timeFrame: post-injection 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks
measure: Modified WOMAC
timeFrame: post-injection 2 weeks, 1, 2, 3,4, 5, 6 months
measure: Lequesne index
timeFrame: post-injection 2 weeks, 1, 2, 3,4, 5, 6 months
measure: SF-36
timeFrame: post-injection 2 weeks, 1, 2, 3,4, 5, 6 months
measure: Time up and go test
timeFrame: post-injection 1, 3, 6 months
measure: Complications
timeFrame: post-injection 1, 2 weeks
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: Thammasat University
state: Pathum Thani
Study officials:
affiliation: Thammasat University
name: Nattapol Tammachote, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06466291: Spanish Wilson Disease Registry
Official title: Registro de Enfermedad de Wilson en España
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Wilson Disease
Keywords: Genetic disease
Registry
Copper
Wilson Disease
Lead sponsor: Asociación Española para el Estudio del Hígado
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Wilson Disease patients under follow-up in participating centres in Spain who agree to participate in the registry by signing the informed consent form.

Brief summary: The main objective and purpose of the Registry is to know the current status of Wilson Disease in Spain.

As secondary objectives, the prevalence and incidence of the disease will be analysed.

Likewise, the analysis aims to define future areas of interest in its pathogenesis, diagnosis, natural history, follow-up, prognosis and treatment.

Improving knowledge at a national level can help to design screening strategies and improve diagnostic circuits.

Detailed description: Retrospective and prospective study.

Eligibility criteria: Inclusion Criteria:

* Patients with a confirmed Wilson Disease diagnosis

Exclusion Criteria:

* Refusal to sign the informed consent for the study

Primary outcomes:
measure: To know the current status of Wilson Disease in Spain
timeFrame: 2025
Secondary outcomes:
measure: To analyse the prevalence of Wilson Disease in Spain
timeFrame: 2025
measure: To analyse the incidence of Wilson Disease in Spain
timeFrame: 2025
Other outcomes:
measure: To define future areas of interest in Wilson Disease
timeFrame: 2025
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Asociación Española para el Estudio del Hígado
name: Zoe Mariño
role: STUDY_DIRECTOR
References:
Clinical trial NCT05915091: Comparative Effects of Dry Needling and Cross Friction Massage on Patients With Plantar Fascitis, RCT
Official title: Comparative Effects of Dry Needling and Cross Friction Massage on Patients With Plantar Fascitis, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plantar Fascitis
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Effectiveness Comparative Effects of Dry Needling and Cross Friction Massage on Patients With Plantar Fascitis


Eligibility criteria: Inclusion Criteria:

* Patients With Plantar Fascitis

Exclusion Criteria:

* Other Health Issues

Primary outcomes:
measure: Pain Scale of Plantar Fasciitis
timeFrame: 3 Months
measure: Foot Health Status Questioner Score
timeFrame: 3 Months
measure: Foot Function Index Score
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Azra Naheed Medical College, Superior University
state: Punjab
Study officials:
References:
Clinical trial NCT04933591: Impact of Treatment With VENARUS® on the Level of Monocyte Chemoattractant Protein 1 in Varicose Veins Blood
Official title: Impact of Treatment With VENARUS® on Vein-specific by Determining the Level of Monocyte Chemoattractant Protein 1 in Varicose Veins Blood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to find if the venoactive drug contained diosmin and hesperidin is able to work against chronic vein-specific inflammation by changing the level of Monocyte Chemoattractant Protein 1. This chemokine is involved in the vein wall remodeling in patients with lower limb varicose veins.

Detailed description: The study is a post-registration open-label observational prospective single-center study with minimal intervention. Individuals aged 18-50 with varicose veins and CEAP C2-C4, Ep, As, Pr will be invited to participate in the study.

Those who agree, will be examined both clinically and by duplex ultrasound. Medical history of participants will be taken, demographic data will be collected. Blood will be drawn from the varicose vein of the affected limb. Discomfort in the affected limb will be evaluated by a visual-analog scale. Duplex ultrasound will be used in every resident to reveal pathological venous reflux in deep and superficial veins.

Eligibility criteria: Inclusion Criteria:

* • both female and male

  * age from 18 to 50 years old
  * Verified diagnosis of chronic venous insufficiency CEAP C2-C4
  * signed infromed consent
  * Absence of any other treatment 2 weeks before the start of the study and throughout the duration of the study

Exclusion Criteria:

* • age less than 18 and more than 50 years

  * Previously performed invasive interventions for varicose veins on any of the lower extremities
  * No visible varicose veins
  * Thrombophlebitis and deep vein thrombosis of the lower extremities in the past
  * Taking prohibited pre-trial therapy
  * Contraindications to taking Venarus®
  * not signed informed consent

Primary outcomes:
measure: Change from Baseline in the level of Monocyte Chemoattractant Protein 1 level in blood taken from varocse vein
timeFrame: 2 months
Secondary outcomes:
measure: Change from baseline of discomfort related to symptoms of varicose veins (i.e., pain, heaviness, etc.)
timeFrame: 2 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Pirogov Russian National Research Medical University
Study officials:
affiliation: Pirogov Russian National Research Medical University
name: Igor Zolotukhin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00171691: Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Official title: Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Knee osteoarthritis, Topical NSAID, Diclofenac sodium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 450
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will test the efficacy and safety of topical Voltaren in the treatment of knee osteoarthritis.


Eligibility criteria: Key Inclusion criteria

• Osteoarthritis of the knee

Key Exclusion criteria

* Other rheumatic disease, such as rheumatoid arthritis
* Active gastrointestinal ulcer during the last year
* Known allergy to analgesic drugs

Primary outcomes:
measure: Incidence of treatment-emergent adverse events
measure: Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12
Secondary outcomes:
measure: Incidence of serious treatment-emergent adverse events
measure: Number of patients who discontinued study medication due to a treatment-emergent adverse event
measure: WOMAC pain, physical function and stiffness scores at Months 3, 6, 9 and 12
Other outcomes:
Locations:
city: Parsippany
country: United States
facility: Novartis Consumer Health Inc.
state: New Jersey
Study officials:
References:
citation: Peniston JH, Gold MS, Alwine LK. An open-label, long-term safety and tolerability trial of diclofenac sodium 1% gel in patients with knee osteoarthritis. Phys Sportsmed. 2011 Sep;39(3):31-8. doi: 10.3810/psm.2011.09.1918.
Clinical trial NCT02557191: Biomarkers, Neurodevelopment and Preterm Infants
Official title: Biomarkers to Predict Neurodevelopmental Outcomes in Very Preterm Infants
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Preterm
Neurodevelopmental Disorder
Epigenetic Changes
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Albert Einstein College of Medicine
First posted: 2015-09-23
Enrollment: 4
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Preterm infants \<32 weeks GA

Brief summary: Approximately 2% of neonates in the US are born very preterm. Preterm births are associated with impaired cognitive, language and motor function, and increased risk for autism spectrum disorders. Epidemiological studies indicate a dose-response relationship between gestational age at delivery and cognitive impairments, with the most immature of newborns being the most susceptible to developmental delays. Sensitive and reproducible biomarkers of long-term neurocognitive impairments are currently lacking. The investigators seek to identify epigenetic markers that mediate the relationship between adverse prematurity-related exposures and neurocognitive impairments. The overarching hypothesis of this proposal is that DNA methylation profiles of CD34+ hematopoetic progenitor and stem cells from very preterm infants can be used as a risk-stratifying biomarker for predicting neurocognitive impairment in childhood.


Eligibility criteria: Inclusion Criteria:

* \<32 weeks" gestation
* Born at Weiler Division of Montefiore

Exclusion Criteria:

* Intraventricular hemorrhage
* Chromosomal abnormalities
* Congenital viral conditions

Primary outcomes:
measure: Brain white matter development
timeFrame: 38-42 weeks adjusted age
Secondary outcomes:
measure: Neurodevelopment
timeFrame: 38-42 weeks adjusted age
measure: Neurodevelopment
timeFrame: 18-24 months adjusted age
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Jack D. Weiler Hospital
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Mamta Fuloria, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01010191: Harnessing Placebo Effects: Non-Deceptive Use of Placebo in Irritable Bowel Syndrome (IBS)
Official title: Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: irritable bowel syndrome
no organic digestive disease
Lead sponsor: Harvard University Faculty of Medicine
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
First posted: 2009-11-09
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Irritable bowel syndrome patients will be given either placebo pill or no treatment for a period of 3 weeks.

Detailed description: Seventy patients with irritable bowel syndrome (IBS) will be randomized to either 1) placebo pill or 2) no treatment and followed for 3 weeks. The study will involve three visits: baseline, midpoint and end point. At baseline all patients will physical examination, be evaluated for IBS and be administered standardized IBS questionnaires including: "IBS adequate relief" questionnaire, IBS global symptom improvement scale, IBS quality of life and IBS symptom severity scale. At midpoint and endpoint the same questionnaires will be administered. Patients on no treatment will be offered education on managing IBS at the end of the study.

Eligibility criteria: Inclusion Criteria:

* Irritable bowel syndrome.

Exclusion Criteria:

* Any signs of organic bowel disease such as rectal bleeding.
* No other major illnesses.

Primary outcomes:
measure: IBS Global Improvement Scale
timeFrame: 3 weeks
Secondary outcomes:
measure: IBS Adequate Relief
timeFrame: 3 weeks
measure: IBS quality of life (QoL)
timeFrame: 3 weeks
measure: IBS Symptom Severity Scale
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
citation: Kaptchuk TJ, Friedlander E, Kelley JM, Sanchez MN, Kokkotou E, Singer JP, Kowalczykowski M, Miller FG, Kirsch I, Lembo AJ. Placebos without deception: a randomized controlled trial in irritable bowel syndrome. PLoS One. 2010 Dec 22;5(12):e15591. doi: 10.1371/journal.pone.0015591.
Clinical trial NCT02878291: Safety Study of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
Official title: A Single-center, Open, Phase I Clinical Trial to Evaluate Safety of Meningococcal ACYW135 Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged Above 3 Months
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Meningitis, Meningococcal
Lead sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Guangxi Center for Disease Control and Prevention
name: Sanjiang Center for Disease Control and Prevention
name: National Institutes for Food and Drug Control, China
name: Air Force Military Medical University, China
name: Simoon Record Pharma Information Consulting Co., Ltd.
First posted: 2016-08-25
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate safety of meningococcal ACYW135 polysaccharide conjugate vaccine in healthy volunteers aged above 3 Months


Eligibility criteria: Inclusion Criteria:

* 3-11 months health infants who haven't immuned with Meningococcal A and C Conjugate Vaccine and population above 1 year old who have't given boost immunity.
* Subject or legal representative who consent and has signed written informed consent.
* Subject who did't immune with any live vaccine within 14 days and inactivated vaccine within 7 days before vaccination.
* Subject and parent/guardian who is able to comply with all study procedures.
* Axillary temperature ≤37.0 ℃.

Exclusion Criteria:

* History of allergy，eclampsia, epilepsy, encephalopathy and mental disease or family disease.
* Allergic history after vaccination.
* History of meningitis infection disease.
* Acute Febrile illness and Infectious Diseases.
* Febrile illness (temperature ≥ 38°C) in the 3 days.
* Immunodeficiency diseases patients who administered with immunosuppressive agents.
* Children within 1 year old with abnormal labor, asphyxia rescue history,congenital malformations,genetic defects, eccyliosis or severe chronic disease.
* Liver and kidney or cardiopulmonary disease，acute hypertension and diabetes.
* In pregnancy or lactation or pregnant women.
* Subject who plan to participate in or is in any other drug clinical trial.
* Meningococcal vaccine contraindication.
* Any condition that, in the judgment of investigator, may affect trial assessment.

Primary outcomes:
measure: Occurrence of adverse events during a 30 day follow-up period after each vaccination
timeFrame: 30 day after each vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Sanjiang
country: China
facility: Sanjiang Center for Disease Control and Prevention
state: Guangxi
Study officials:
affiliation: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
name: Du lin, Master
role: STUDY_CHAIR
References:
Clinical trial NCT05903391: Splint Users' Satisfaction and Functional Status With Custom Finger Splints
Official title: Splint Users' Satisfaction and Functional Status With Custom Finger Splints: A Feasibility and Comparison Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypermobility of Interphalangeal Joints
Swan-Neck Deformity
Keywords: 3d-printing
technology
finger splints
hypermobile joints
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This feasibility and non-randomized comparison study explores the possible benefits of splint design and production by 3D-printing in a clinical setting and looks at splint users' experiences with customizable 3D-printed finger splints compared to conventionally made splints. Fifty participants with a hyperextended finger condition are assigned by researcher to either an interventional group (customizable 3D-printed finger splint) or a control group (conventional thermoplastic finger splint). Participants will wear assigned splint for 1 month. Functional status and satisfaction with splint will be assessed at the end of the 1-month duration in the form of surveys on satisfaction and functional status participants will be asked to complete. The findings will contribute to evidence that customizable 3D-printed finger splints can serve as a feasible, cost-effective option to improve patient satisfaction and functional status. It will further justify the need for the application of 3D-printing in a clinical setting.


Eligibility criteria: Inclusion Criteria:

* Fluent in English
* 18 years or older
* Finger proximal interphalangeal joint (PIP) joint hyperextension (with or without swan-neck deformity)
* Pregnant or not pregnant women
* Able to tolerate a finger orthosis over the course of 1 month
* Not decisionally impaired
* Have or have not previously worn a finger orthosis for symptoms

Exclusion Criteria:

* Non-fluent in English
* Decisionally impaired
* Younger than 18 years old
* No proximal interphalangeal joint (PIP) joint finger hyperextension
* Unable to tolerate a finger orthosis over the course of 1 month

Primary outcomes:
measure: Modified Version of Orthotics and Prosthetics User Survey - Satisfaction with Device
timeFrame: 1 month
measure: Modified Version of Orthotics and Prosthetics User Survey - Functional Status
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Swedish Hospital Part of NorthShore University HealthSystems
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
References: