louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02961634: Study Efficacy and Safety in Comparative Use of Investigational Product Adjuvant Treatment in Onychomycosis
Official title: Study Efficacy and Safety in Comparative Use of Investigational Product Adjuvant Treatment in Onychomycosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Onychomycosis
Keywords: onychomycosis
nail
Lead sponsor: MIP Brasil Indústria e Comércio de Produtos Farmacêuticos LTDA
Sponsor class: INDUSTRY
Collaborators: name: Buranello e Rodrigues Consultoria em Desenvolvimento Farmacêutico Ltda ME
First posted: 2016-11-11
Enrollment: 46
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: SUPPORTIVE_CARE

Brief summary: Single-center study, single blind, comparative with the objective of evaluating the efficacy and safety of an investigational product as an adjunct in the treatment of onychomycosis improvement of 90 days ± 2 days.


Eligibility criteria: Inclusion Criteria:

* Volunteers of both sexes;
* Volunteers aged 18-65 years;
* Volunteers with onychomycosis confirmed by positive direct mycological nail of hands or feet;
* Agreement to comply with the test procedures and attend the clinic in the days and times for certain applications and / or assessments;
* Understand, consent and sign the Instrument of Consent of Clarified.

Exclusion Criteria:

* Pregnancy or risk pregnancy / lactation;
* Use of anti-inflammatory / immunosuppressive drugs (in the last 30 days and during the study);
* Concomitant nail pathologies (psoriasis, lichen planus, etc.);
* Systemic conditions that may compromise the growth of the nail (vascular disease, diabetes, etc.);
* Irritation History to similar products to the investigational product;
* Treatment with antifungal medication prior to the study (up to 12 weeks for systemic medications and topical medications for four weeks);
* Other conditions considered by the investigator physician as reasonable for the disqualification of the individual's participation in the study.

Primary outcomes:
measure: Percent of improvement of mycosis by reducing the area of the lesion that will be measured at times D1 and D90
timeFrame: 90 days
Secondary outcomes:
measure: Presence of fungal structures in nail affected by onychomycosis in visits 1 and final through mycological examination
timeFrame: 90 days
measure: Number of patients reporting reduction in discomfort caused by onychomycosis through a subjective evaluation questionnaire
timeFrame: 45 and 90 days
measure: Number of adverse events reported and related to the product investigational
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02554617: Measurements of Exhaled Nitric Oxide in Healthy Subjects in Thailand
Official title: Measurements of Exhaled Nitric Oxide in Healthy Subjects in Thailand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Non-fluency
Keywords: healthy people
fractional exhaled nitric oxide (FeNo)
factors
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-09-18
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: The purpose of this study is to determine fractional exhaled nitric oxide (FeNO) level in healthy subjects among Thai populations.

Detailed description: Fractional exhaled nitric oxide (FeNO) were produced from epithelial cells of inflammatory airways and eosinophils and this gas was discovered since 1991.

Fractional exhaled nitric oxide (FeNO) has direct association with severity of inflammation of bronchial trees and sputum eosinophils and use for additional investigation for diagnosis asthma or inflammatory airway diseases.

There are many factors from previous studies that associate with level of fractional exhaled nitric oxide (FeNO), one of that factors is race therefore we can't use level from another studies with different race for use as reference and there is no study about level of fractional exhaled nitric oxide in Thai population.

It is therefore desirable to examine level of fractional exhaled nitric oxide (FeNO) in healthy subjects among Thai population and will be the main objective of this research.

Eligibility criteria: Inclusion Criteria:

* healthy subjects in community

Exclusion Criteria:

* smoker or past history of smoking
* asthma, allergic rhinitis, chronic respiratory disease or other chronic illness
* history of wheezing within 12 months before enrollment
* history of upper or lower respiratory tract infection within 6 weeks before enrollment
* drink ethanol within 48 hours before enrollment
* drink caffeine within day before enrollment
* during pregnancy
* chronic use of any drugs
* participate other project within 30 days

Primary outcomes:
measure: fractional exhaled nitric oxide level
timeFrame: 10 minutes (average time ), on the day of enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
name: Professor Nualanong Visitsunthorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05233917: Effects of Olive Oil and MLCT on Glycolipid Homeostasis in Patients With Metabolic Syndrome
Official title: The Precision Nutritional Management for MetS (PNMM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidaemia
Metabolic Syndrome
Keywords: Olive oil
MLCT oil
plasma metabolome
gut microbiota
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 240
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The type of cooking oil used is a crucial factor influencing dietary quality. The purpose of this study is to investigate the effects of olive oil and MLCT oil intervention on glucose and lipid homeostasis in patients with MetS.

Detailed description: We conducted a 6-month RCT to evaluate the effects of olive oil and MLCT as cooking oils on glucose and lipid homeostasis in patients with MetS; investigate the changes in lipoprotein subfractions and metabolites using NMR spectroscopy, alongside gut microbiota alterations, to elucidate potential mechanisms; and identify baseline variables associated with the anti-obesity effects of olive oil and MLCT.

Eligibility criteria: Inclusion Criteria:

Participants eligible for the study were those with a confirmed MetS diagnosis according to the IDF criteria53, aged between 40 and 70, and who reported infrequent consumption of meals outside the home (≤3 times per week)

Exclusion Criteria:

(i) current breastfeeding or pregnancy; (ii) history of cardiovascular disease, including heart disease, coronary artery disease, stroke, cerebral infarction, viral hepatitis (e.g., hepatitis A or B), chronic kidney disease (estimated glomerular filtration rate \[GFR\] \<60 ml/min), or malignancy; (iii) presence of diabetic ketoacidosis or hyperketonemia; (iv) recent alterations in prescribed medication within the previous 6 months; (v) current use of insulin therapy; (vi) consumption of MLCT in the preceding 6 months; (vii) participation in other clinical research studies within the last 6 months; and (viii) premenopausal women

Primary outcomes:
measure: Change in body weight from baseline
timeFrame: 6 month
measure: Change in triglycerides from baseline
timeFrame: 6 month
measure: Change in Body fat distribution and muscle conten from baseline
timeFrame: 6 month
Secondary outcomes:
measure: Change in waist circumference from baseline
timeFrame: 6 month
measure: Change in MetS indicators from baseline
timeFrame: 6 month
measure: Change in gut microbiota from baseline
timeFrame: 6 month
measure: Change in blood metabolome
timeFrame: 6 month
Other outcomes:
Locations:
city: Jinhua
country: China
facility: Lanxi Hospital of Traditional Chinese Medicine
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Yu Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01493817: Biomarkers in Samples From Younger Patients With Wilms Tumor
Official title: Observational - Relationships Between Tumor-Associated Macrophages and Clinicopathological Factors in Wilms Tumor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wilms Tumor and Other Childhood Kidney Tumors
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-12-16
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Wilms tumor patients

Brief summary: This research study is studying biomarkers in tissue samples from younger patients with Wilms tumor. Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients respond to treatment

Detailed description: PRIMARY OBJECTIVES:

I. To determine whether recruitment of tumor-associated macrophages is related to clinicopathological factors in Wilms tumor (tumor stage, presence of vascular invasion, tumor progression, and survival).

OUTLINE:

Paraffin-embedded specimens are analyzed for macrophage markers. Results of each sample are then compared with patient's tumor stage, presence of vascular invasion, tumor progression, and survival.

Eligibility criteria: Inclusion Criteria:

* Wilms tissue microarray samples provided by the Children's Oncology Group

Primary outcomes:
measure: Relationship of tumor-associated macrophages and prognosis
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Jessica Kandel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00244517: DIAFAX I+II-Effects of Inhalative Anesthetics on Left Ventricular Diastolic Function
Official title: The Effects of Remifentanil, Sevoflurane, Isoflurane and Desflurane on Left Ventricular Diastolic Function in Humans
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Young Healthy Adults
Ventricular Dysfunction
Keywords: ventricular function
diastolic function
inhalative anaesthetics
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2005-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Anaesthetics may impair the diastolic function of the heart, but the importance of this finding for patients has not been sufficiently examined. Specially the effects on diastolic function in patients with diastolic dysfunction has to be determined. The aim of this study is to examine the effect of isoflurane (only part I), sevoflurane and desflurane (part I+II) on the diastolic left ventricular function by doppler echocardiography.

Detailed description: In part I, 60 healthy young subjects free from cardiovascular disease will be examined. In part II, 50 patients with impaired diastolic but preserved systolic function, i.e., patients with arterial hypertension and ejection fraction \> 50%. Doppler echocardiography will be performed at baseline before induction of anaesthesia, during anaesthesia in the spontaneously breathing patient, and in the mechanically ventilated patient.

Eligibility criteria: Inclusion Criteria:

* part I: 18- to 50-year-old patients undergoing surgical procedures under general anesthesia
* part II: 50-years-old patients or older with arterial hypertension under chronic antihypertensive medication subsequently undergoing surgical procedures under general anesthesia, EF \>50%

Exclusion Criteria:

* part I: any cardiac or pulmonary disease, any medication with cardiovascular effects or side effects, body mass index \> 30 kg/m2, esophageal reflux, emergency
* part II: History of myocardial infarction or coronary revascularization, severe lung disease, body mass index \> 30 kg/m2, esophageal reflux, emergency

Primary outcomes:
measure: To determine the effect of the opiate remifentanil and of the inhalative anaesthetics isoflurane (only part I), sevoflurane and desflurane on the diastolic function of the left ventricle in healthy young adults, and in patients with diastolic dysfunction
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital
state: CH
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Manfred Seeberger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04409717: Evaluation of the Long Term Efficacy of Endovascular Treatment of Type 2 Endoleaks
Official title: Evaluation of the Long Term Efficacy of Endovascular Treatment of Type 2 Endoleaks
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients treated for type II endoleaks by endovascular therapy between the 01 January 2008 and the 31 December 2018

Brief summary: Endovascular treatment has become the first choice to repair abdominal aortic aneurym, but exposes patients to a risk of endoleaks. Although treatment of type 1 and 3 endoleaks has proven to prevent aneurysms from rupture, controversies remain about type 2 endoleaks. The investigators described the different techniques of type 2 endovascular repair, and their efficacy at short and long term..


Eligibility criteria: Inclusion Criteria:

* All patients treated for type II endoleaks by endovascular therapy

Exclusion Criteria:

* None

Primary outcomes:
measure: Recurrence rate of type II endoleaks treated with endovascular intervention
timeFrame: 12 years
Secondary outcomes:
measure: Type of type II endoleaks treatment
timeFrame: 12 years
Other outcomes:
Locations:
city: Dijon Cedex
country: France
facility: Cardiovascular and thoracic surgery unit, CHU Dijon
Study officials:
affiliation: Cardiovascular and Thoracic Surgery Unit - Dijon Univeristy Hospital
name: Eric STEINMETZ, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06310317: Applied Behavior Analysis With Technologies
Official title: Evaluating the Effect of Use of Technologies to Increase the Cognitive Abilities in Children With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism
Autism Spectrum Disorder
Keywords: Autism
autism spectrum disorder
children
Applied Behavior Analysis
ABA
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Applied Behavior Analysis (ABA) is a therapeutic approach for autism that is based on the principles of behavioral theory, learning, and positive reinforcement. Current research shows that early and intensive ABA intervention is effective in reducing dysfunctional behaviors and promoting learning and enactment of socially appropriate behaviors.

In this context, new approaches that attempt to integrate advanced technologies can play a key role. This experimental protocol aims to test whether the use of advanced technologies, such as tablets, as part of an intervention for a group of children with autism spectrum disorder (ASD) is more effective than the traditional approach implemented in a control group of children with ASD. The experimental protocol is aimed at enhancing cognitive skills, increasing new skills and acquiring functional/adaptive behaviors.


Eligibility criteria: Inclusion Criteria:

* Children with diagnosis of autism

Exclusion Criteria:

* presence of other medical disorders

Primary outcomes:
measure: Verbal Behavior Milestones Assessment and Placement Program (VB-MAPP)
timeFrame: the test need approximately 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Study officials:
affiliation: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
name: Flavia Marino
role: PRINCIPAL_INVESTIGATOR
References:
citation: Choi KR, Bhakta B, Knight EA, Becerra-Culqui TA, Gahre TL, Zima B, Coleman KJ. Patient Outcomes After Applied Behavior Analysis for Autism Spectrum Disorder. J Dev Behav Pediatr. 2022 Jan 1;43(1):9-16. doi: 10.1097/DBP.0000000000000995.
citation: Yu Q, Li E, Li L, Liang W. Efficacy of Interventions Based on Applied Behavior Analysis for Autism Spectrum Disorder: A Meta-Analysis. Psychiatry Investig. 2020 May;17(5):432-443. doi: 10.30773/pi.2019.0229. Epub 2020 May 8.
citation: Valencia K, Rusu C, Quinones D, Jamet E. The Impact of Technology on People with Autism Spectrum Disorder: A Systematic Literature Review. Sensors (Basel). 2019 Oct 16;19(20):4485. doi: 10.3390/s19204485.
Clinical trial NCT01255917: Nerve Growth Factor in Chronic Pancreatitis
Official title: Nerve Growth Factor in Chronic Pancreatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pancreatitis
Keywords: Tio identify role of NGF in pain in CP
Identify biomarkers related to progression of CP
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2010-12-08
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Test group: Subjects with CP in each morphological stage and matched for age, race, gender, narcotic dependence and etiology of CP will be enrolled Controls: Subjects undergoing upper gastrointestinal endoscopy (UGIE) for non-pancreatic causes.

Brief summary: This study is to understand the role of nerve growth factor(NGF) and other cytokines in the pancreatic fluid of patients with chronic pancreatitis.

Hypothesis:

1. Pain does not correlate with changes in the PD morphology suggesting that pain in CP is not only a mechanical problem
2. Pain in CP correlates better with the levels of NGF in the pancreatic juice. NGF is variably expressed in different morphological stages of CP and regulates the sensitivity of the peptidergic nociceptors and is upregulated in pancreatic inflammation.


Eligibility criteria: Inclusion Criteria:

* Patients with established CP and none of the exclusion criteria mention below.

Exclusion Criteria:

* Failure to obtain consent.
* Any comorbid condition with expected survival \< 1 year.
* Patients with pacemaker, implanted metallic prosthesis or other contraindications to do MRCP.
* Patients \< 18 years of age at time of consent

Primary outcomes:
measure: The levels of NGF in subjects with different morphological stages of chronic pancreatitis (CP) will be compared to the controls and in each morphological stage of CP will be correlated with pain scores.
timeFrame: 5 years
Secondary outcomes:
measure: Correlate the expression of NGF and other inflammatory cytokines in the pancreatic juice in each morphological stage of CP.
timeFrame: 5 years
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
Study officials:
affiliation: Associate Professor, VCU Medical Center
name: Bimaljit S Sandhu, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02056717: Use of Dexamethasone in Uterine Artery Embolization
Official title: The Effect of Dexamethasone on Inflammatory Response After Uterine Artery Embolization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Myoma
Adenomyosis
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2014-02-06
Enrollment: 64
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to investigate the effects of dexamethasone on inflammatory reactions after uterine artery embolization. The secondary purpose of this study it to investigate the effects of dexamethasone on postembolization syndrome (severe pain, nasea and vomiting).


Eligibility criteria: Inclusion Criteria:

* Uterine artery embolization due to multiple myoma or adenomyosis

Exclusion Criteria:

* Diabetic mellitus
* Steroid administration
* Liver or kidney dysfuntion
* High baseline CRP or leukocytosis (\>11,000/μL )
* Drug allergy

Primary outcomes:
measure: Inflammatory reactions
timeFrame: 24 hours
Secondary outcomes:
measure: Pain
timeFrame: 24 hours
measure: Nausea and vomiting
timeFrame: 24 hours
measure: Sucessful rate at 3 month after UAE
timeFrame: 3 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT01482117: The Effect of Genetic Polymorphism on Interactions of Clopidogrel and Cilostazol in Healthy Volunteers
Official title: Randomized, Open-label, Crossover Study to Evaluate the Effect of Genetic Polymorphism on Pharmacokinetic & Pharmacodynamic Interactions of Clopidogrel and Cilostazol in Korean Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Interaction
Keywords: CYP2C19
CYP3A5
Clopidogrel
Cilostazol
Healthy
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2011-11-30
Enrollment: 28
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to investigate the effects of genetic polymorphisms on pharmacokinetic and pharmacodynamic interactions of clopidogrel and cilostazol in Korean healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male subject whose CYP2C19 genotype was determined

Exclusion Criteria:

* Subject who has abnormal laboratory test results

Primary outcomes:
measure: Maximum concentration(Cmax), Area under the concentration(AUC), Inhibition of platelet aggregation(IPA)
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Inje University
name: Jae-Gook Shin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: