louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01198249: Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide in Subjects With (Pre)Hypertension
Official title: A Randomized, Open Label, Multiple Dose, Crossover Study to Investigate Pharmacokinetic Drug Interactions Between Single and Concomitant Administrations of Amlodipine, Losartan, and Hydrochlorothiazide(HCTZ) in Subjects With (Pre)Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Essential Hypertension
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 23
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: This study is aimed to evaluate the pharmacokinetics and the drug-drug interaction among anti-hypertension drugs-amlodipine, losartan, and hydrochlorothiazide. This pilot study provides useful information to develop a new fixed dose combination drug.


Eligibility criteria: Inclusion Criteria:

* Adult subjects 20-50 years of age
* Above 55Kg and within ±20% ideal body weight
* Subjects who are in average of 130mmHg ≤ systolic blood pressure (SBP) \< 160mmHg, 80mmHg ≤ diastolic blood pressure (DBP) \< 100mmHg
* Female subject who confirmed non-pregnant status and agree to comply with proper contraception.
* Subjects who wrote informed consent

Exclusion Criteria:

* Subjects who are suspected to have acute disease
* Subjects who have past history that may affect drug absorption, distribution, metabolism and elimination
* Subjects who have gastrointestinal history
* Subjects whose heartrate is less than 60
* Subject who suspected to orthostatic hypotension
* Subjects who have clinically significant allergy disease
* Subject is currently participating or has participating in a study with an investigational compound or device within 30 days of signing informed consent
* Administration of prescription drug within 14 days or over the counter (OTC) drug within 7 days
* Subjects who have past history of drug abuse and positive in drug screening test
* Subjects who donate whole blood within 60 days and platelet within 30days.
* Subjects taking St John's wort or CYP inhibitor and inducer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Severance Hospital
name: Jae-Yong Chung, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01874249: Non Invasive Assessment of Liver Fibrosis in Fatty Liver Disease
Official title: Randomized Clinical Trial to Detect Advanced Fibrosis by Non-invasive Methods in Subjects With Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non Alcoholic Fatty Liver Disease
Keywords: Hepatic fibrosis
Steatosis
Noninvasive markers.
Lead sponsor: Fundación Clínica Médica Sur
Sponsor class: OTHER
First posted: 2013-06-11
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this randomized clinical trial is to evaluate the utility of noninvasive markers for the detection of advanced fibrosis in patients newly diagnosed with Non-alcoholic Fatty Liver Disease (NAFLD) by ultrasound.

The primary objective is to determine the effectiveness of noninvasive markers for detect of advanced fibrosis in patients with diagnosis of fatty liver disease.

The secondary objectives are:

* To determine the increase in health care with the specialist (gastroenterologist or endocrinologist).
* To determine which noninvasive evaluation strategy favors any treatment of fatty liver disease.


Eligibility criteria: Inclusion Criteria:

* Patients with BMI ≥ 27 Kg/m2 and any stage of non alcoholic fatty liver, diagnosed by ultrasound.

Exclusion Criteria:

* Patients with other liver disease.
* Patients under treatment with tamoxifen, methotrexate, amiodarone, diltiazem or other drugs able to induce fatty liver.
* Patients with alcohol consumption greater than 140 gr. per week
* Patients who have received blood transfusion before 1990

Primary outcomes:
measure: Advanced Fibrosis by any diagnostic modality
timeFrame: One year after the diagnosis of steatosis.
Secondary outcomes:
measure: Specialized care
timeFrame: One year after the diagnosis of steatosis.
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Medica Sur Clinic & Foundation
state: DF
Study officials:
References:
citation: Chavez-Tapia NC, Barrientos-Gutierrez T, Torres-Ibarra L, Sanchez-Jimenez B, Juarez-Hernandez E, Ramos-Ostos M, Alva-Lopez LF, Uribe M. Incremental levels of diagnostic information incentivize health-seeking in non-alcoholic fatty liver: a randomized clinical trial. Sci Rep. 2022 May 18;12(1):8272. doi: 10.1038/s41598-022-12295-1.
Clinical trial NCT01232049: Drug Interaction and Safety Between Pitavastatin and Valsartan (CWP-PTV-101)
Official title: A Randomized, Open-label, Multiple Dose, Crossover Study to Evaluate a Pharmacokinetic Drug Interaction and Safety Between Pitavastatin and Valsartan in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: healthy volunteers
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: JW Pharmaceutical
First posted: 2010-11-02
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is designed to evaluate a pharmacokinetic drug interaction and safety between Pitavastatin and Valsartan in healthy male subjects


Eligibility criteria: Inclusion Criteria:

* Adult males aged 20 to 50 years at screening.
* No significant congenital/chronic disease. No symptoms in physical examination.
* Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
* Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.

Exclusion Criteria:

* History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
* History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
* History of known hypersensitivity to drugs including valsartan and pitavastatin.

Primary outcomes:
measure: Safety (normal results for safety tests)
timeFrame: 39days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Kyun-Seop Bae, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jung JA, Noh YH, Jin S, Kim MJ, Kim YH, Jung JA, Lim HS, Bae KS. Pharmacokinetic interaction between pitavastatin and valsartan: a randomized, open-labeled crossover study in healthy male Korean volunteers. Clin Ther. 2012 Apr;34(4):958-65. doi: 10.1016/j.clinthera.2012.01.026. Epub 2012 Mar 10.
Clinical trial NCT06123949: The Effect of Galvanic Stimulation on vHIT and VEMP Tests
Official title: The Effect of Galvanic Stimulation on vHIT and VEMP Tests
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular System Disorder
Keywords: galvanic vestibular stimulation
VEMP
vHIT
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Introduction: Galvanic vestibular stimulation (GVS) is a well-established technique with a history spanning over a century, primarily used to manipulate the vestibular system. Recent interest has surged in its potential for understanding human vestibular function and aiding in functional recovery. GVS applies electrical currents to the mastoid region, modulating vestibular afferents, and induces specific effects based on the participant's posture and current polarity. While GVS's impact on the central nervous system and its potential to aid in functional recovery have been studied, its immediate effects on vestibular reflexes remain less explored.

Methods: In this study, thirty healthy adult participants underwent ocular and cervical vestibular evoked myogenic potential (VEMP) tests, as well as the velocity Head Impulse Test (vHIT) before and immediately after one hour of GVS application. Statistical analyses were performed to assess changes in VEMP and vHIT results.


Eligibility criteria: Inclusion Criteria:

* No history of hearing loss and/or balance disorders
* No physical (neck) problems
* No history of psychological or neurological disorders
* Not using alcohol and/or vestibular suppressant drugs regularly
* Feeling balanced in daily life

Exclusion Criteria:

* History of hearing loss and/or balance disorders
* Physical (neck) problems
* History of psychological or neurological disorders
* Using alcohol and/or vestibular suppressant drugs regularly

Primary outcomes:
measure: Cervical Vestibuler Evoked Myogenic Potentials
timeFrame: 5 months
measure: Ocular Vestibuler Evoked Myogenic Potentials
timeFrame: 5 months
measure: Video Head Impulse Test
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
References:
Clinical trial NCT05678049: Evaluation and Characterisation of Microplastics and Nanoplastics in Joint Synovial Liquid
Official title: Evaluation and Characterisation of Microplastics and Nanoplastics in Joint Synovial Liquid
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoarthritis, Knee
Knee Arthritis
Gout Arthritis
Microcrystal Disease
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients on a Rehab Department with arthritis of the knee that require evacuation of the knee joint

Brief summary: The research study aims to evaluate the synovial fluid to highlight the presence of possible micropolymers (micro/nanoplastics) in order to better understand the pathophysiology of joint degenerative processes. For patients with liquid under tension at the joint level, the symptomatology often requires evacuation by puncture under ultrasound guidance. The intervention will be performed only for patients for whom this therapeutic indication exists anyway by their physician.

The investigators want to use this liquid for Microscopic and Spectrophotometric evaluation.


Eligibility criteria: Inclusion Criteria:

* arthritis of the knee with liquid aspiration recommendation
* age \>18 years

Exclusion Criteria:

--refusal of the patient to participate

-age\<18 years

Primary outcomes:
measure: microplastics
timeFrame: immediately after liquid extraction
measure: nanoplastics
timeFrame: immediately after liquid extraction
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03696849: Clinical Assessement of Glazed Versus Polished Lithium Disilicate Crowns in Surface Roughness and Enamel Antagonists Wear
Official title: Patient Satisfaction and Clinical Assessment of Surface Roughness and Wear of Enamel Antagonists for Polished Versus Glazed Posterior Lithium Disilicate Glass Ceramic Crowns
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Decay
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-10-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is believed that final glazing yields the most acceptable ceramic surfaces in terms of smoothness. However, since reglazing must be performed in a dental laboratory with the use of a thermal furnace, it requires multiple office visits. Repeated firings have a destructive effect on ceramic surfaces and can cause deformation. Conversely, polishing is easy and simple and can be accomplished in a single session.


Eligibility criteria: Inclusion Criteria:

* Patients from 18-50 years old who are able to read and sign the informed consent document.
* Physically and psychologically able to tolerate conventional restorative procedures.
* Have no active periodontal or pulpal diseases, have teeth with good restorations.
* Patients have no temporomandibular disorders.
* Each participant needed a crown on either a first or second premolar or first or second molar in any arch.
* Teeth selected shoud include:

restorability with a crown:root ratio of at least 1:1. presence of an opposing natural tooth which was non-restored or minimally restored.

the presence of two non-restored or minimally restored teeth opposing each other on the same quadrants as the crowned tooth and the opposing to serve as enamel controls. Minimally restored was defined as teeth which have no restoration greater than a Class II amalgam restoration.

- Willing to return for follow-up examinations and evaluation.

Exclusion criteria

* Patients in the growth stage with partially erupted teeth.
* Patients with poor oral hygiene and motivation.
* Pregnant women.
* Psychiatric problems or unrealistic expectations.
* Lack of opposite occluding dentition in the area intended for restoration.
* Patients with temporomandibular disorders.

Primary outcomes:
measure: Antagonists enamel wear using profilometer
timeFrame: 1 year
Secondary outcomes:
measure: Restoration surface Roughness using profilometer
timeFrame: 1 year
measure: Patient satisfaction
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04108949: Small Children, Big Emotions
Official title: Tuning in to Kids: an Effectiveness Evaluation of Emotion Coaching to Parents and Daycare Teachers of At-risk Young Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Emotional Disturbances
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: University of Melbourne
name: Extrastiftelsen
First posted: 2019-09-30
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial with two arms.
Primary purpose: TREATMENT

Brief summary: The study is a randomized controlled trial evaluating the clinical and cost-effectiveness of Tuning in to Kids (TIK) compared to treatment as usual (TAU). Participants are recruited among referred children aged 2-5 years with difficulties with emotion regulation. The study setting is Child and Adolescent Mental Health Services clinics. Parents of children randomized to TIK will attend 8 two-hourly group sessions. A brief version of TIK will be offered to the child's daycare teacher. Participants are assessed at baseline, week 12 and month 9 after inclusion. The primary clinical outcome is Coping with Toddlers' Negative Emotions Scale.


Eligibility criteria: Inclusion Criteria:

* Referred children aged 2-5 years
* The child is enrolled in daycare
* The child is displaying problems with emotional dysregulation

Exclusion Criteria:

* Parent not sufficiently proficient in Norwegian Language to Complete assessment
* Child Protective Services have ongoing assessment where the outcome may be that the child will be placed in care outside of the home of the biological parent(s) or other current caregiver
* The child has already been diagnosed with an autism spectrum disorder

Primary outcomes:
measure: Coping with Toddlers' Negative Emotion Scale
timeFrame: CTNES will be completed at baseline, post treatment (week 12) and follow-up month 9 after inclusion) to evaluate change from baseline to post-treatment and follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Jessheim
country: Norway
facility: BUP Øvre Romerike
city: Oslo
country: Norway
facility: BUP Grorud
city: Oslo
country: Norway
facility: Nic Waals Institutt
Study officials:
affiliation: University Hospital, Akershus
name: Marianne Aalberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06679049: Comparison of Healing Measures Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing
Official title: Comparison of Healing Measures in Diaphyseal Tibial Fractures Following Standard Intramedullary Nailing or Micromotion Tibial Intramedullary Nailing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tibial Fractures
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Subjects Undergoing Tibial Fracture Repair
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to perform a high-quality randomized control trial comparing intramedullary tibial nail fixation with standard design nails to a micromotion tibial nail device, to evaluate the rates of union and post-operative outcomes.


Eligibility criteria: Inclusion Criteria:

* Age 18 - 85 years
* Stable Tibial fracture recommended for surgical intervention

Exclusion Criteria:

* Patients not meeting inclusion criteria
* Unstable fracture patterns e.g. those needing a secondary intervention - masquelet/cement spacer)
* Previously non-ambulatory patients
* Delayed presentation of fracture (\>4 weeks)
* Fractures that the treating surgeon indicates requires additional fixation strategies to achieve stability
* Patients with an achieve infection or wound at the surgical site
* Any previous ligament or fracture surgery on the index site
* Inflammatory rheumatic disease or other rheumatic disease-
* Immune compromised patients (hepatitis, HIV, etc.)
* Unwilling or unable to participate or follow study protocol

Primary outcomes:
measure: The difference in radiographic union
timeFrame: 12,18 and 24 weeks between micromotion intramedullary fixation and standard IMN post operatively
Secondary outcomes:
measure: difference in complication rates
timeFrame: 1 year post-operatively
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Main Hospital
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Joseph Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05012449: Transitional Ankle Fracture Management Using a New Joystick Technique
Official title: Transitional Ankle Fracture Management Using a New Joystick Technique
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tibial Fracture
Keywords: Arthrography, Joystick technique, Adolescent, Ankle fracture
Lead sponsor: The Fuzhou No 2 Hospital
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To investigate the feasibility and short-term clinical efficacy of the arthrography-assisted joystick technique for the treatment of adolescent transitional ankle fracture.

Detailed description: Adolescent transitional ankle fracture who were treated with the arthrography-assisted joystick technology.

Eligibility criteria: Inclusion Criteria:

1. X-ray or computed tomography (CT) diagnosis of adolescent transitional ankle fracture.
2. After manual reduction, the displacement of both ends of the epiphyseal plate or articular surface fracture in any direction was still \> 2 mm; the arthrography-assisted joystick technique was used for treatment.

Exclusion Criteria:

1. Bilateral fracture.
2. In association with epiphyseal dysplasia and neuromuscular disease.

Primary outcomes:
measure: Radiographic union
timeFrame: Through study completion, an average of 0.5 year.
Secondary outcomes:
measure: American Orthopedic Foot and Ankle Society (AOFAS) ankle score system.
timeFrame: Through study completion, an average of 0.5 year.
Other outcomes:
measure: Measurement methods of the mechanical axis of lower limbs .
timeFrame: Through study completion, an average of 0.5 year.
Locations:
city: Fuzhou
country: China
facility: Shunyou Chen
state: Fujian
Study officials:
affiliation: The Fuzhou No 2 Hospital
name: Shunyou Chen, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT05494749: Zirconia Reinforced Glass Ionomer in MIH
Official title: Effectiveness Of Zirconia Reinforced Glass Ionomer Used In Alternative Restorative Treatment In Molar Incisor Hypomineralization (A Randomized Controlled Clinical Trial And Finite Element Analysis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Molar Incisor Hypomineralization
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-08-10
Enrollment: 88
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Molar-incisor hypomineralization (MIH) is a qualitative enamel defect, in which molars and incisors involved are prone to post-eruptive enamel breakdown leading to sensitivity, and caries. Atraumatic/Alternative Restorative Treatment (ART) is a minimally invasive procedure. It can be very beneficial in managing MIH-affected molars in communities with limited access to dental care. Zirconia-reinforced GI was recently introduced. It is claimed to serve as a long-term temporary restoration until a more permanent restoration is placed


Eligibility criteria: Inclusion Criteria:

* Children free from any systemic disease (ASA I).
* Cooperative children showing positive or definitely positive behavior according to Frankl rating scale
* Hypomineralized first permanent molars that are restorable according to MIH Treatment Need Index (MIH-TNI): Index (2a), (2b), (4a), (4b)
* Teeth with dentinal lesions corresponding to ICDAS II score 5 or 6
* No clinical or radiographic evidence of pulpal involvement.

Exclusion Criteria:

* Index (0), (1), (2c), (3), (4c) on the MIH Treatment Need Index.
* Patients whose parents will not give their consent to participate in the study
* Non-restorable first permanent molars indicated for extraction

Primary outcomes:
measure: Change in clinical success rate
timeFrame: at 3 months, 6 months, 9 months, 12 months
Secondary outcomes:
measure: Change in pain
timeFrame: at 1 week, 3 months, 6 months, 9 months, 12 months
measure: Change in sensitivity
timeFrame: at 1 week, 3 months, 6 months, 9 months, 12 months
measure: Finite element analysis
timeFrame: 12 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
affiliation: Alexandria University, Faculty of Dentistry
name: Reham A Mahfouz, MSc
role: PRINCIPAL_INVESTIGATOR
References: