louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05076812: Interleukin 38 as a Biomarker for Metabolic Syndrome in Psoriatic Patients
Official title: Interleukin 38 as a Biomarker for Metabolic Syndrome in Psoriatic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psoriasis
Keywords: psoriasis
metabolic syndrome
interleukin 38
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people attending the Dermatology Outpatient Clinics of Sohag University Hospital.

Brief summary: case control study to compare level of interleukin 38 in patients with psoriasis and patients with metabolic syndrome with healthy control subjects

Detailed description: this case control study will measure plasma level of interleukin 38 in 4 groups of 24 subject, group one will have psoriatic patients, group 2 will have psoriatic patients with metabolic syndrome, group three will have patients with metabolic syndrome only, and group 4 will have healthy control subjects.

Eligibility criteria: Inclusion Criteria:

* specific to each group

Exclusion Criteria:

* Patient refusal. Age \<18 years Pregnancy Lactation smoking Infections. Patients with other inflammatory skin disorders use of antioxidant and anti-inflammatory drugs patients on treatment for psoriasis

Primary outcomes:
measure: measure plasma level of interleukin 38 in all groups
timeFrame: through study completion an average of 18 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
name: yomna a abdellatif, MBBCH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00142012: School-Based Obesity Prevention Program
Official title: School-Based Obesity Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: School-based
Obesity
Prevention
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
Collaborators: name: University of Pennsylvania
First posted: 2005-09-02
Enrollment: 1500
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The overarching goal of this initiative is to reduce the prevalence and occurrence of obesity and increase the remission of obesity in children and adolescents through implementation of a Comprehensive School Nutrition Policy designed to promote changes in the school environment that will reinforce students' development of healthy eating and physical activity patterns inside and outside of school.

Detailed description: The proposed research aims to evaluate the effects of a school-based nutrition policy initiative on prevalence, incidence and remission of overweight (BMI \> 95th percentile). It is a partnership between the Food Trust, the School District of Philadelphia and the University of Pennsylvania. Participants are approximately 1500 students from ten schools in grades four through eight. Half of the schools were randomized to a comprehensive School Nutrition Policy Initiative (SNPI) based on CDC's Guidelines to Promote Lifelong Healthy Eating. The SNPI is a community-based intervention administered by the Comprehensive School Nutrition Policy Task Force that is comprised of 40 individuals representing the public and private sectors. The goal of the SNPI is to change the school environment to: support healthy eating, increase physical activity, and decrease the prevalence of childhood overweight and diet-related diseases. The remaining study participants are in five control schools, matched for ethnicity, SES, and type of food service. Most students are African American and qualify for free and reduced meals at school (household income \< 185% of the poverty level adjusted for household size). Assessments of weight, height, intake, activity, inactivity and eating disorder symptomatology are being conducted at baseline and 1 and 2 years.

Eligibility criteria: Inclusion Criteria:

* Any child in 4th, 5th, 6th grades in study site schools

Exclusion Criteria:

* Any child not in 4th, 5th, 6th in study site schools

Primary outcomes:
measure: Weightloss
measure: Weight maintenance
Secondary outcomes:
measure: Risk for overweight status (BMI 85th to 95th percentile)
measure: BMI z-scores, calculated for a given age and gender, will show a greater decline in intervention subjects versus controls
Other outcomes:
Locations:
Study officials:
affiliation: U. of Pennsylvania
name: Gary D. Foster, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04568512: DNA Methylation Biomarker for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture
Official title: DNA Methylation Biomarker in Biliary Brush Sample for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholangiocarcinoma
Biliary Stricture
DNA Methylation
Brush Cytology
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: DNA methylation biomarker for diagnosis of cholangiocarcinoma in patients with bile duct stricture has high sensitivity and specificity compared with cytology from the brush specimens

Detailed description: The methylation of HOXA1, NEUROG1 were used to determine cholangiocarcinoma from brushed biliary samples. However, the sensitivity and specificity of this test for cholangiocarcinoma is still required.

Eligibility criteria: Inclusion Criteria:

* Age more than 18 year old
* Patients had biliary stricture from cholangiocarcinoma and benign stricture

Exclusion Criteria:

* Pregnancy
* Patient had other malignancy

Primary outcomes:
measure: The methylation of HOXA1, NEUROG1 were determined in brushed biliary samples from patients with CCAs compared to those of nonmalignant bile duct stricture
timeFrame: 2 weeks
Secondary outcomes:
measure: Sensitivity, specificity of DNA methylation for diagnosis of cholangiocarcinoma
timeFrame: 2 weeks
measure: To compared sensitivity, specificity of DNA methylation with routine cytology of biliary brushed samples
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of medicine, Siriraj hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Varayu Prachayakul
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prachayakul V, Rugivarodom M, Nopjaroonsri P, Cheirsilpa K, Chang A, Kamolhan T, Boonyaarunnate T, Thuwajit C, Thuwajit P. Diagnostic power of DNA methylation markers suggestive of cholangiocarcinoma in ERCP-based brush cytology. Gastrointest Endosc. 2022 Jan;95(1):123-130.e1. doi: 10.1016/j.gie.2021.07.005. Epub 2021 Jul 12.
Clinical trial NCT00382746: EarlySense Monitoring Device Evaluation on CHF Patients
Official title: EarlySense Monitoring Device Evaluation on CHF Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Congestive Heart Failure
Keywords: Congestive
Heart
Failure
CHF
Lead sponsor: EarlySense Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Rambam Health Care Campus
First posted: 2006-09-29
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: CHF patients will be monitored using EarlySense ES-16 device and will simultaneously fill diaries and log their weight daily. The data collected and analyzed by the ES-16 device will be correlated with the CHF status data.


Eligibility criteria: Inclusion Criteria:

* Age over 45 years old
* CHF class II or III with LVEF\<40%
* Hospitalized at least once for CHF deterioration over previous 12 month period
* Able and willing to cooperate with this trial for at least a 3 month period
* Home close to participating center

Exclusion Criteria:

* Recent (within 3 month) admission to ICU or CC-ICU due to severe CHF episode requiring artificial ventilation
* Asthma or COPD

Primary outcomes:
measure: CHF
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Shmuel Rispler, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06457646: mRNA Expression and Genetic Polymorphisms Affecting DRD3 (rs6280) and HTR2A (rs6313) in Bruxism
Official title: mRNA Expression and Genetic Polymorphisms Affecting DRD3 (rs6280) and HTR2A (rs6313) in Bruxism
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bruxism
Keywords: Gene Expression
Bruxism
Sleep bruxism
Polymorphism
Genetic
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 170 participants will be included in this study.

Brief summary: The goal of this observational study is to learn about the genetic factors influencing bruxism, a condition characterized by teeth grinding, in a group of participants. The main questions it aims to answer are:

* Is there a significant association between the rs6313 polymorphism of the HTR2A gene and bruxism?
* Is there a significant association between the rs6280 polymorphism of the DRD3 gene and bruxism?

Participants will:

Provide DNA samples for genotyping of the DRD3 (rs6280) and HTR2A (rs6313) polymorphisms.

Provide RNA samples to assess changes in the expression of HTR2A and DRD3. Researchers will compare the genetic data and RNA expression levels between individuals with bruxism and those without (controls) to see if there are significant genetic differences and expression changes associated with bruxism.


Eligibility criteria: Inclusion Criteria:

* be above 18 years of age and have a confirmed diagnosis of bruxism

Exclusion Criteria:

* Systemic diseases,
* orofacial dysfunction,
* acute symptoms such as neurodegenerative diseases (specifically Parkinsons disease),
* Taking medication such as anxiolytics

Primary outcomes:
measure: PCR-RFLP Analysis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Wieckiewicz M, Bogunia-Kubik K, Mazur G, Danel D, Smardz J, Wojakowska A, Poreba R, Dratwa M, Chaszczewska-Markowska M, Winocur E, Emodi-Perlman A, Martynowicz H. Genetic basis of sleep bruxism and sleep apnea-response to a medical puzzle. Sci Rep. 2020 May 4;10(1):7497. doi: 10.1038/s41598-020-64615-y.
Clinical trial NCT04976946: Protocol for CAMUS Delphi Study
Official title: Protocol for CAMUS Delphi Study: A Consensus on Reporting of Complications After Urological Surgeries
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complications; Urogenital, Postprocedural
Lead sponsor: Melbourne Health
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Local and international consultant Urologists, accredited Urology trainees, consultant Anaesthetists and consultant ICU specialists will be invited to complete the survey. Critical care physicians who are primarily Urological anaesthetists or have experience in complication reporting will be targeted. Must be over the age of 18 years.

Brief summary: Multi-staged, international Delphi study that aims to establish criteria for standardised complication reporting in Urology.

Detailed description: The CAMUS Delphi Study: A Consensus on Reporting of Complications After Urological Surgeries is a multi-staged, international Delphi study that aims to establish criteria for standardised complication reporting in Urology. The initial survey consists of a 12-part questionnaire that will aim to reach consensus on a wide range of contentious issues in Urological surgery using the frameworks of both the established Clavien-Dindo Classification (CDC) and the new CAMUS Classification.

To ensure comprehensive and comparable complication reporting across centres worldwide, a conclusive uniform language for reporting complications must be created and subsequently integrated. Accurate reporting will allow for more precise allocation of resources, improve unit efficiency, and reduce healthcare burden, while providing clinicians with a better understanding of intra- and post-operative morbidity. If a comprehensive, homogenous reporting construct is integrated worldwide, the potential to build and develop a universal database with complications from all centres around the world will surely provide invaluable data to create new guidelines and recommendations, ultimately improving patient counselling and surgical quality of care.

Eligibility criteria: Inclusion Criteria:

* Local and international consultant Urologists, accredited Urology trainees, consultant Anaesthetists and consultant ICU specialists will be invited to complete the survey. Critical care physicians who are primarily Urological anaesthetists or have experience in complication reporting will be targeted.

Exclusion Criteria:

* All other specialists that do not meet the inclusion criteria.
* Under 18 years of age.

Primary outcomes:
measure: Standardised complication reporting in Urology
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Royal Melbourne Hospital
Study officials:
affiliation: Melbourne Health
name: Marc A Furrer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06409546: Impact of Topical Pentoxifylline and Tocopherol in Treatment and Prevention of Medically-related Osteonecrosis of the Jaws
Official title: Impact of Topical Pentoxifylline and Tocopherol in Treatment and Prevention of Medically-related Osteonecrosis of the Jaws: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medically Related Osteonecrosis of the Jaws
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: While there is no doubt about the benefits of antiresorptives, it is known that patients using these drugs are at increased risk of developing osteonecrosis of the jaws (MRNOJ), especially after oral procedures such as tooth extraction. The management of osteonecrosis has remained a controversial topic within the oral and maxillofacial surgery community.

The aim of the present study is to analyze the impact of topical pentoxifilline and tocopherol in the prevention and treatment of MRNOJ.

Detailed description: A double-blind randomized controlled clinical trial is conducted in order to evaluate the impact of topical pentoxifilline and tocopherol in the prevention and treatment of MRNOJ and determine the statistical significance of the outcome variables.

48 subjects with MRNOJ, randomly allocated in two groups: placebo group with a 4% hydroxyethyl cellulose adhesive gel and the treatment group with the same gel containing pentoxifilline 5% and tocopherol 75%.

Eligibility criteria: Inclusion Criteria:

* Correspondence to the updated SIPMO criteria for MRONJ diagnosis
* Need for tooth extraction

Exclusion Criteria:

* Recent use of antibiotics and anti-inflammatories in the last 4 weeks
* Oral lesions of hard and soft tissues not related to MRONJ

Primary outcomes:
measure: Oral Health Impact Profile Short Form (OHIP-14)
timeFrame: 6 months
Secondary outcomes:
measure: Alveolar bone resorption
timeFrame: 6 months
Other outcomes:
Locations:
city: Catania
country: Italy
facility: AOU Policlinico G. Rodolico
state: CT
Study officials:
References:
Clinical trial NCT05274646: Impact on Risk Stratification of Overlap Syndrome Phenotype in Patients With E1784K Mutation in SCN5A
Official title: Impact on Risk Stratification of Overlap Syndrome Phenotype (Brugada and Long QT Type 3) in Patients With E1784K Mutation in SCN5A
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Long QT Syndrome
Brugada Syndrome
Cardiac Conduction System Disease
Arrhythmias, Cardiac
Keywords: Long QT syndrome type 3
Brugada Syndrome
SCN5A gene
E1784K mutation
Cardiac arrhythmias
Cardiac conduction system disease
phenotypic overlap
overlap syndrome
sodium channelopathie
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 64
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with hereditary cardiac disease

Brief summary: In patients expressing the SCN5A-E1784K mutation (Glu1784Lys), cardiovascular risk is difficult to define as the stratification of these patients is challenging. From our experience, major cardiovascular events (MCE) tend to occur more frequently in patients expressing overlap syndrome phenotype (Brugada syndrome and Long QT syndrome type 3)than in patients expressing a single phenotype (whether Brugada syndrome or Long QT syndrome type 3). This trials is led on the impact on Risk Stratification of Overlap Syndrome Phenotype in Patients With E1784K Mutation in SCN5A ( RISKOVER )

Detailed description: Study design: This study will compare the occurrence of MCE between patients with overlap syndrome phenotype and patients with a single phenotype (whether Brugada syndrome or Long QT syndrome type 3) in a cohort of patients 12 years of age and older with the SCN5A-E1784K mutation. Eligible patients will be identified nationwide and included retrospectively and prospectively. Occurrence of MCE between the group " overlap syndrome " and the group " single phenotype " will be compared.

Eligibility criteria: Inclusion Criteria:

* genotype E1784K (glu1784lys) in SCN5A gene

Exclusion Criteria:

* none

Primary outcomes:
measure: Occurrence of MCE
timeFrame: at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Pierre
country: Réunion
facility: CHU de La Réunion
state: France
Study officials:
affiliation: CHU de La Réunion
name: Maxime CHURET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00198146: Prevention of Diabetes Progression Trial (PDPT)
Official title: PD Initiated/Prevention of Diabetes Progression Trial (PDPT) ZEN119
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Newly Diagnosed With Type 1 Diabetes
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Pescovitz, Mark D., M.D.
name: Roche Pharma AG
name: Facet Biotech
First posted: 2005-09-20
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to determine the efficacy and safety of daclizumab in preventing the progression of diabetes in children who have just been diagnosed with type I diabetes. Additional purposes of the study are to investigate the amount of drug in the children, how quickly it is eliminated from the blood, and analyze the effect of the drug on the immune reaction to diabetes.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed type 1 diabetes without previous insulin or oral hypoglycemic therapy.
* ages 2 to 40 years at diagnosis
* enroll within 3 months of diagnosis
* test positive for at least one of the biochemical autoantibodies (ICA-512, GAD 65 or IAA) prior to enrolling

Exclusion Criteria:

* Previous treatment with an anti-IL-2 directed monoclonal antibody or any other investigational agent that would interfere with the ability to evaluate the safety and efficacy of daclizumab.
* Other immunosuppressive drugs including, but not limited to, corticosteroids, cyclosporine, tacrolimus, rapamycin, mycophenolate mofetil, or azathioprine.
* Active significant infection
* Limited life expectancy because of disease other than diabetes
* Pregnancy

Primary outcomes:
measure: Area under the curve, Glucagon Stimulation Testing for c-peptide measurements at 0, +6min and +10min intervals over 2 years
Secondary outcomes:
measure: HbA1c
measure: Insulin requirements (units/kg/day)
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University - Riley Hospital for Children
state: Indiana
Study officials:
affiliation: Indiana University - Riley Hospital for Children
name: Mark D Pescovitz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01089946: Cardiovascular Changes and Changes in Tissue Oxygenation During Early Postoperative Mobilization in Total Hip Arthroplasty (THA) Patients
Official title: Cardiovascular Changes and Changes in Tissue Oxygenation During Early Postoperative Mobilization After Primary Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty
Keywords: Mobilization
Hip arthroplasty
cardiovascular
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2010-03-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing primary THA.

Brief summary: The purpose of this study is to investigate the cardiovascular changes during early postoperative mobilization of hip arthroplasty patients.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Primary THA

Exclusion Criteria:

* Alcoholism
* Known orthostatic hypotension
* Daily use of anxiolytic medication

Primary outcomes:
measure: Orthostatic intolerance
timeFrame: 6 and 24 hours postoperative
Secondary outcomes:
measure: Orthostatic hypotension
timeFrame: 6 and 24 hours postoperative
Other outcomes:
Locations:
city: Hørsholm
country: Denmark
facility: Hørsholm Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Oeivind Jans, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jans O, Bundgaard-Nielsen M, Solgaard S, Johansson PI, Kehlet H. Orthostatic intolerance during early mobilization after fast-track hip arthroplasty. Br J Anaesth. 2012 Mar;108(3):436-43. doi: 10.1093/bja/aer403. Epub 2011 Dec 15.
citation: Jans O, Brinth L, Kehlet H, Mehlsen J. Decreased heart rate variability responses during early postoperative mobilization--an observational study. BMC Anesthesiol. 2015 Aug 22;15:120. doi: 10.1186/s12871-015-0099-4.