louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06417463: Role of TIRADS and Bethesda Scoring Systems in Management of Thyroid Nodules
Official title: Role of TIRADS and Bethesda Scoring Systems in Management of Thyroid Nodules
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Nodule
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients will proved to have single or multinodular goitre \& patients with thyroid nodules more than 1 cm

Brief summary: role of TIRADS and Bethesda scoring system in management of thyroid nodules as these methods are ultrasound clasification that helps increase the diagnostic effectiveness of thyroid nodules and reduces the use of preopeative FNA .that nodules are usually divided into diffent categories based on TIRADS and are then referred to FNA and follow up according to variable risk of maligneny.

Detailed description: this study is an observational study will be conducted on patiend with thyroid nodules will be admitted to general surgical department at sohag university hospital . patients will be approved to have single or multinodular goitre and thyroid nodules more than 1 cm . thyroid nodules are very common disease with great clinical importance although most cases are benign and only 4.5% to 6.5% are malignant ... itis necessary to distinguish those cases to reduce frequency of unnecessary thyroidectomies ... ultrasound classification and Fine needle aspiration (FNA) are first line diagnostic procedures and help in decrease cases undergoing unnecessary thyroidectomies as 50% of the nodules removed recently are malignant and the number of patients undergoing surgery is significantly reduced.

Eligibility criteria: Inclusion Criteria:

* patients will proved to have single or multinodular goitre thyroid nodules more than 1cm

Exclusion Criteria:

* thyroid nodules less than 1 cm history of thyroid surgery history of radiotherapy

Primary outcomes:
measure: managemnt thyroid nodules
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: AlSaedi AH, Almalki DS, ElKady RM. Approach to Thyroid Nodules: Diagnosis and Treatment. Cureus. 2024 Jan 13;16(1):e52232. doi: 10.7759/cureus.52232. eCollection 2024 Jan.
citation: Bojunga J, Trimboli P. Thyroid ultrasound and its ancillary techniques. Rev Endocr Metab Disord. 2024 Feb;25(1):161-173. doi: 10.1007/s11154-023-09841-1. Epub 2023 Nov 10.
citation: Cibas ES, Ali SZ. The 2017 Bethesda System for Reporting Thyroid Cytopathology. Thyroid. 2017 Nov;27(11):1341-1346. doi: 10.1089/thy.2017.0500.
citation: Pemayun TG. Current Diagnosis and Management of Thyroid Nodules. Acta Med Indones. 2016 Jul;48(3):247-257.
Clinical trial NCT05906563: Evaluation of Melatonin and Metformin Loaded Nanoparticles in the Treatment of Periodontal Intra-bony Defects
Official title: Clinical and Radiographic Evaluation of Melatonin and Metformin Loaded Nanoparticles in the Treatment of Periodontal Intra-bony Defects: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bone Loss in Jaw
Keywords: nanoparticles
melatonin
metformin
intra-bony defect
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 52
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to assess the effectiveness of local delivery of melatonin and metformin loaded nanoparticle gel as adjunct to scaling and root planning (SRP) in the treatment of periodontal intra bony defect.

fifty two healthy patients(n=52) with at least one periodontal intra-bony defect will be included in the study, all selected patients will be motivated about the benefit of plaque control and periodontal treatment . The participant will be selected from outpatient clinic of the Department of Oral Medicine and Periodontology , Faculty of dentistry, Mansoura University . The participant will be classified into four groups :group I and II are test groups but group III and IV are control groups .Patients in group I will be treated with melatonin loaded nanoparticle gel while in group II will be treated with melatonin and metformin loaded nanoparticles which will be applied weekly for four weeks after SRP had been completed and group III will be treated with placebo gel while group IV will be treated with only scaling and root planning.


Eligibility criteria: Inclusion Criteria:

* patients with at least one intra-bony defect diagnosed clinically and radiographically

Exclusion Criteria:

* Patients with systemic diseases.
* Pregnant and lactating females.
* Smokers and tobacco chewers.
* History of antibiotic and periodontal therapy in the last 3 months.
* Patients not compliant with oral hygiene procedures.
* Patients with a known or suspected allergy to the melatonin or metformin.
* Individuals on systemic drug affecting metabolic bone diseases and medically compromised patients.

Primary outcomes:
measure: Radiographic assessment
timeFrame: all the parameter will be evaluated after 6 months
Secondary outcomes:
measure: plaque index according to Silness P.Loe H 1964
timeFrame: 6 months
Other outcomes:
measure: Gingival bleeding index(GBI - Ainamo & Bay, 1975)
timeFrame: 6 months
measure: Probing Pocket depth (PPD)
timeFrame: 6 months
measure: Clinical Attachment level (CAL)
timeFrame: 6 months
Locations:
city: Mansoura
country: Egypt
facility: Amira R agab AL-agooz
state: Dakhlia
Study officials:
affiliation: Mansoura University, Faculty of Dentistry
name: Amira R AL-Agooz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01688063: Skin Elasticity Measurements of the Face and Surgical Scars Stratified by Age and Skin Type
Official title: A Pilot Study of Skin Elasticity Measurements of the Face and Surgical Scars Stratified by Age and Skin Type
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Skin Scarring
Skin Elasticity
Keywords: Skin Elasticity
Scar Elasticity
Cutometer
Dermal Torque Meter
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 350 subjects who meet the inclusion/exclusion criteria for either study Part A, Part B or both will be consented and enrolled with the goal of having 100 subjects complete Part A and 250 subjects complete Part B. Subjects will be recruited from the Dermatology Clinic at Northwestern University and other Northwestern University clinics.

Brief summary: The primary objective of Part A is to compare the change in elasticity measurements at baseline and at 3 months between subjects who have had a resurfacing or tightening procedure and those who have not. The secondary objective for Part A is to develop baseline elasticity scores for ages 18-35, 36-50, and 51-65 and for Fitzpatrick skin types I-II, III-IV, and V-VI. The primary objective of Part B is to compare the age of the scar and surrounding tissue with the elasticity measurements.


Eligibility criteria: Inclusion Criteria:

Part A:

* Subject is 18-65 years of age
* Subject scheduled to have resurfacing or tightening procedure done as Standard of Care (Arm 1, 25 subjects).
* The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator

Part B:

* Subject is 18 and over
* Subject has a linear surgical scar that is \> 2cm.
* The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator

Exclusion Criteria:

Part A, Group 1:

-Subject is planning on having a cosmetic procedure done to their face during the 3 months they are participating in the study (Arm 2, 25 subjects).

Parts A and B:

* Under 18 years of age
* Pregnancy or Lactation
* Subjects who are unable to understand the protocol or to give informed consent
* Subjects with mental illness

Primary outcomes:
measure: Skin elasticity measurement of participant's scars
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine, Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02542163: Pilot Evaluation of the NimbleHeart Harness System in Cardiac Rehabilitation (PEN-CR)
Official title: Pilot Evaluation of the NimbleHeart Harness System in Cardiac Rehabilitation (PEN-CR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Rehabilitation
Lead sponsor: NimbleHeart Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-04
Enrollment: 20
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: Cardiac Rehabilitation phase II population

Brief summary: Purpose: To conduct a pilot study to assess the feasibility of the NimbleHeart wireless telemetry vest in cardiac rehabilitation.

Study Design: This is a prospective, single center, non-randomized, pilot trial evaluating the NimbleHeart chest harness system.

Detailed description: 20 subjects will be consented to participate at an early cardiac rehabilitation exercise session (typically sessions 1-6). Subjects will wear the NimbleHeart vest concurrently with existing telemetry system during exercise sessions, and thus not replace existing telemetry monitoring. Both staff and subjects will be queried for their (user) experiences during and after each session. Experiences will be documented on surveys after each session. De-identified ECG rhythm strips from the NimbleHeart monitor will be collected to assess quality of tracings. Subjects will be asked to wear the NimbleHeart vest for 2 sessions. Study participation will end after the 2nd session.

Eligibility criteria: Inclusion Criteria:

1. Participating in the Cardiac Rehabilitation Program.
2. Capable of giving, and willing to sign, informed consent.

Exclusion Criteria:

1. Patients with either unstable heart disease or unstable heart failure and for whom exercise is contraindicated.
2. Presence of Ventricular Assist Device (VAD).

Primary outcomes:
measure: Degree of difficulty in attaching the harness as compared to attaching the standard telemetry system.
timeFrame: 3 to 4 months
measure: Reported occurrences of subject discomfort
timeFrame: 3 to 4 months
measure: Quality of ECG tracings during exercise
timeFrame: 3 to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References:
Clinical trial NCT04693663: Treatment of Residual Myopic Refraction After 6 Months on Pseudophakic Patients Using Relex-Smile
Official title: Treatment of Residual Myopic Refraction After 6 Months on Pseudophakic Patients Using Relex-Smile
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Pseudophakia
Myopia
Lead sponsor: Eye Hospital Pristina Kosovo
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One group consisting of 40 eyes
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess visual and refractive outcomes after laser vision correction (LVC) - ReLex Smile to correct residual myopic refraction after 6 months of pseudophakic (IOL) implantation.

Before SMILE YAG-Laser capsulotomy should be performed on all patients, regardless of posterior capsule ossification, in pseudophakic patients with residual refraction. When the YAG Laser is applied after the SMILE, there will be a diopter change.

Detailed description: The residual myopic refraction after 6 month on pseudophakic patients using Relex-Smile surgery using VisuMax Femtosecond Laser.The residual myopic refractive power is between -0.75D till -5.50D.The optical zone(lenticule diameter) and cap diameter were 6.5 and 7.5 mm respectively.After dissection of both anterior and posterior planes, the lenticule was extracted through 120 degree superior 3.5mm incision and marked with a sterile marker(Viscot-Medster)

Eligibility criteria: Inclusion Criteria:

* residual myopic refraction -0.75d till -5.50D
* complain visual acuity regarding residual myopic refraction

Exclusion Criteria:

* active anterior segment pathologic features
* previous corneal or anterior segment surgery
* glaucoma
* history of ocular inflammation

Primary outcomes:
measure: Increase of visual acuity
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pristina
country: Kosovo
facility: Eye Hospital Pristina
Study officials:
References:
citation: Semiz F, Lokaj AS, Musa NH, Semiz CE, Demirsoy ZA, Semiz O. SMILE for the Treatment of Residual Refractive Error After Cataract Surgery. Ophthalmol Ther. 2022 Aug;11(4):1539-1550. doi: 10.1007/s40123-022-00526-7. Epub 2022 May 28.
Clinical trial NCT05432063: Urdu Version of Oxford Shoulder Score Scale: Reliability and Validity Study
Official title: Evaluation of Reliability and Validity of Urdu Version of Oxford Shoulder Score Scale Among Pakistani Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Shoulder Pain
Keywords: Oxford Shoulder Score Scale
Urdu Version
Reliability
Validity
Shoulder Pain
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pakistani general population with shoulder pain.

Brief summary: The primary goal of this study is to translate and culturally adapt the Oxford Shoulder Score Scale into Urdu, as well as to assess its reliability and validity in the Urdu-speaking Pakistani community. This research will also look at the relationship between Oxford Shoulder Score Scale and the Shoulder Pain And Disability Index and Short Form - 36 scores for shoulder pain.

Detailed description: The English version of the Oxford Shoulder Score Scale will be translated and culturally modified into Urdu. The Oxford Shoulder Score Scale, as well as other correlation measures, will be disseminated among 104 individuals in the Pakistani Urdu speaking community, who will be chosen using a convenience sample approach and based on pre-defined inclusion and exclusion criteria. For the intra- and inter-observer validity and reliability of the Oxford Shoulder Score Scale, Shoulder Pain And Disability Index, and Short Form - 36, questionnaires will be filled on the same day by two observers, with a two-hour gap between the first and second application. This is the inter-observer evaluation. The third application for the intra-observer evaluation will be completed after 7 days. Statistical Package of Social Sciences Version 26 will be used to enter and analyses the data. The internal consistency will be assessed using the Cronbach alpha value. The test-retest reliability will be assessed using an inter-class correlation coefficient. The content validity, criteria and construct validity, as well as responsiveness, of the Oxford Shoulder Score Scale scale will be assessed.

Eligibility criteria: Inclusion Criteria:

* Age above 18 years
* Documented cognitive impairment
* Patient with shoulder instability
* Acute traumatic shoulder injury

Exclusion Criteria:

* Age under 18 years
* Recent surgery
* Pain origination from neoplasms
* Systemic arthritic

Primary outcomes:
measure: Oxford Shoulder Score Scale
timeFrame: 1st day
measure: Shoulder Pain And Disability Index
timeFrame: 1st day
measure: Short Form - 36
timeFrame: 1st day
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT02135263: Metabolism of Methylphenidate and Enalapril Based on CES1 Genotype
Official title: Metabolism of Methylphenidate and Enalapril Based on CES1 Genotype
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Carboxylesterase 1 (CES1) Genotype
CES1 Activity
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: The Ministry of Science, Technology and Innovation, Denmark
name: Mental Health Centre Sct. Hans (Denmark)
name: University of Copenhagen
name: The Leiden Academic Center for Drug Research (LACDR)
name: Duke University
First posted: 2014-05-09
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether differences in the gene coding for the liver enzyme carboxylesterase 1 (CES1) means differences in the metabolism of two CES1 dependent drugs, enalapril and methylphenidate.


Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* Caucasian

Exclusion Criteria:

* Chronic disease (except hay fever and eczema)
* Pregnancy
* Smoking
* High level of alcohol consumption (\> 21 units per week for men and 14 for women)
* Known allergy towards methylphenidate and enalapril
* Permanent use of medication (contraception ok)

Primary outcomes:
measure: Peak plasma concentration (Cmax) of methylphenidate
timeFrame: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
measure: Time to peak plasma concentration (Tmax) of methylphenidate
timeFrame: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
measure: Terminal half life (t½) of methylphenidate
timeFrame: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
measure: Area under the plasma concentration versus time curve (AUC) of methylphenidate
timeFrame: Predose, ½, 1, 1½, 2, 2½, 3, 4, 6, 8, 10, 24 and 33 hours post-dose
measure: Peak plasma concentration (Cmax) of enalapril
timeFrame: Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
measure: Time to peak plasma concentration (Tmax) of enalapril
timeFrame: Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
measure: Terminal half life (t½) of enalapril
timeFrame: Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
measure: Area under the plasma concentration versus time curve (AUC) of enalapril
timeFrame: Predose, ½, 1, 2, 3, 4, 5, 6, 9, 24, 48 and 72 hours post-dose
Secondary outcomes:
measure: Metabolomic profile
timeFrame: Predose/pre-meal, predose/post-meal, 2 and 6 hours post-dose
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Clinical Pharmacology, Bispebjerg University Hospital
Study officials:
affiliation: Department of Clinical Pharmacology, Bispebjerg University Hospital
name: Gesche Jürgens, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01087463: Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming
Official title: Composite Nailing System for the Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Humeral Fractures
Pathological Fractures
Lead sponsor: N.M.B. Medical Applications Ltd
Sponsor class: INDUSTRY
First posted: 2010-03-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and efficacy of the composite Nail - the Quantum interlocking intramedullary nailing system in the reduction of humeral fractures.

Detailed description: The study will include 20 patients who have an acute mid shaft diaphyseal humeral fracture due to injury. The patients will undergo lateral and AP X- ray evaluation of the fracture. Following General anesthesia, closed reduction of the fracture will be performed. It will be followed by nail insertion, percutaneously, according to standard surgical techniques, with the help of the insertion handle and without preliminary reaming. Following insertion the nail will be locked both distally and proximally using interlocking screws. The nail and screws insertion will be monitored by fluoroscopy. Patients will remain under follow up for 6 months following the procedure. In the follow up sessions the fracture will be evaluated by fluoroscopy or X-ray for correct bone alignment, callus formation, and fracture union.

Eligibility criteria: Inclusion Criteria:

* Above 18 years old.
* Mid shaft diaphyseal fracture
* Acute fracture

Exclusion Criteria:

* Patients with metabolic or hormonal diseases that could affect bone healing such as diabetes.
* Ongoing infection in fracture site.

Primary outcomes:
measure: Bone union and callus formation,bone alignment, nail and screws resistance over time
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hilel Yafe Medical Center
Study officials:
affiliation: Hilel Yafe Medical Center
name: Gili Laufer, Orthopedic
role: PRINCIPAL_INVESTIGATOR
References: