louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05211479: Tele Nursing Application For Type 1 Diabetes Mellitus Adolescents
Official title: The Effect Of Tele-Nursing Application On Metabolic Control, Self-Efficacy, Quality Of Life And Anxiety Level Of Adolescents With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telenursing
Adolescent
Type 1 Diabetes Mellitus
Keywords: Telenursing
Type 1 Diabetes Mellitus
Metabolic Control
Self Efficacy
Quality of Life
Anxiety
Lead sponsor: University of Yalova
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 67
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled and quasi-experimental research
Primary purpose: SUPPORTIVE_CARE

Brief summary: Studies have shown that tele-nursing practice is effective in children with Type 1 Diabetes Mellitus, but the number of studies conducted is very few. No study examining the concepts of metabolic control, self-efficacy, quality of life and anxiety together was found in the literature review. With this study, it is aimed that diabetes education given by tele-nursing has an effect on metabolic control, self-efficacy, quality of life and anxiety level of adolescents with type 1 diabetes, and that diabetic adolescents can easily obtain the information they need about nursing care when they cannot come to the clinic.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

* The child is between the ages of 12-18,
* After the information, the adolescent agrees to participate in the study, and the parent gives written consent,
* The child can understand and speak Turkish,
* Parent's ability to understand and speak Turkish,
* Having a smart phone and having access to the internet,
* Having been diagnosed with T1DM at least 1 year ago,
* Being on insulin therapy by the subcutaneous route,
* Coming to the outpatient clinic at least once every 3 months.

Exclusion Criteria:

Exclusion Criteria:

* Age younger than 12 or older than 18,
* Having another chronic disease,
* Using an insulin pump
* Having vision and hearing problems,
* Using the Continuous Glucose Tracking System,
* Having a physical or mental disability.

Primary outcomes:
measure: Evaluation of Metabolic control level of adolescents with type 1 diabetes
timeFrame: Baseline, 12 weeks and 24 weeks after randomization
measure: Evaluation of the level of self-efficacy of adolescents with type 1 diabetes
timeFrame: Baseline, 12 weeks and 24 weeks after randomization
measure: Evaluation of the level of quality of life of adolescents with type 1 diabetes
timeFrame: Baseline, 12 weeks and 24 weeks after randomization
measure: Evaluation of the anxiety level of adolescents with type 1 diabetes
timeFrame: Baseline, 12 weeks and 24 weeks after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Yalova
country: Turkey
facility: Yalova University
Study officials:
affiliation: University of Yalova
name: Emel AVÇİN, Doctorate
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04982679: Relationship Between The Quadriceps Muscle Stiffness And Patellar Alignment For Healthy People
Official title: Relationship Between The Quadriceps Muscle Stiffness And Patellar Alignment For Healthy People
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patellofemoral Maltracking
Keywords: muscle stiffness
patellofemoral alignment
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subject without patellofemoral joint problem

Brief summary: Patellofemoral pain is a common disease, and it often couples with patellar malalignment. Previously, imbalance of the different quadriceps muscle heads was believed to be a causative factor of patellar malignment. However, findings from electromyography studies on quadriceps activities and patellar alignment in the last two decades were inconsistent. In order to better understand the relationship between quadriceps muscle imbalance and patellar malalignment, shear wave elastography (SWE), which can measure the passive and active muscle stiffness, may shed some new lights to this area. This study aims to examine whether the quadriceps muscle stiffness can predict the patellar position. The healthy young adult will be recruited in this study. Active and passive quadriceps muscle stiffness will be measured with the SWE in different conditions and the result will be correlated with the patellar position measured with magnetic resonance imaging (MRI). Also, electromyography (EMG) activity will be measured during the active stiffness measurement so as to establish the level of agreement between the EMG and SWE data. Linear regression will be used to calculate the relationship between different factors. The total number of subjects needed will be 55 by setting an effect size of 0.15 with two predictors, 80% power, and α at 0.05 in the linear regression.

This project will be conducted at PolyU campus and an MRI clinic in Hong Kong. Hopefully, it could be started in July 2021 and will last for 1 year.


Eligibility criteria: Inclusion Criteria:

* Healthy and in the range between 18 and 45 years.

Exclusion Criteria:

* Knee pain in the last 3 months;
* Previous history of knee surgery;
* People with contraindications to having MRI scanning.

Primary outcomes:
measure: Patellofemoral Joint Alignment measured by MRI scanning
timeFrame: Within 1 hour
measure: Muscle stiffness measured by ultragraph using shear wave elastography
timeFrame: Within 1 hour
Secondary outcomes:
measure: Muscle activity measured by electromyography
timeFrame: Within 1 hour
measure: Muscle strength
timeFrame: Within 0.5 hour
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: Hong Kong Polytechnic University
Study officials:
References:
Clinical trial NCT06190379: Aromatherapy for Upper Respiratory Health
Official title: Aromatherapy for Upper Respiratory Health: A Randomized, Placebo Controlled, Triple-Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune System
Lead sponsor: Nutraceuticals Research Institute
Sponsor class: OTHER
Collaborators: name: Prodeco Pharma
First posted: 2024-01-05
Enrollment: 45
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to confirm and quantify the effects of aromatherapy on respiratory health.

Detailed description: Participants will inhale the scent from an aroma stick every waking hour for the entire duration of a period of respiratory symptoms or 14 days, whichever is shorter. As it is a randomized, placebo-controlled study, some participants will inhale the scent from an aroma stick containing active essential oils while other participants will inhale from an aroma stick containing no essential oils.

Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent form
* Stated willingness and demonstrated ability to comply with all study procedures and availability for the duration of the study
* Gender expression: female
* Aged 20-65
* In good general health
* Exhibiting routine upper respiratory symptoms such as: sneezing, coughing, running nose, headache, general fatigue, or dry or sore throat, etc.
* Ability to utilize the inhaler and be willing to adhere to the regimen

Exclusion Criteria:

* Current use of bronchodilators or asthma medications
* Presence of asthma diagnosis or other severe breathing disorder
* Pregnant or trying to conceive
* Known allergic reactions to components of the inhaler, specifically plants in the following families: rutaceae, pinaceae, labiatae, and myrtaceae.
* Treatment with another investigational drug or other intervention within 30 days
* Current smoker
* COVID-19 diagnosis

Primary outcomes:
measure: severity of respiratory symptoms
timeFrame: 14 days
measure: duration of respiratory symptoms
timeFrame: daily up to 14 days
Secondary outcomes:
measure: sleep scores using the Franklin Health Sleep Scale
timeFrame: 14 days
Other outcomes:
Locations:
city: Franklin
country: United States
facility: Franklin Health Research
state: Tennessee
Study officials:
affiliation: Nutraceuticals Research Institute
name: Jessie Hawkins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06668779: Digital Analysis of Primary Teeth Dimensions in a Group of Egyptian Children (4-6 Years)
Official title: Digital Analysis of Tooth Crown Dimensions of Primary Teeth in a Group of Egyptian Children (4-6 Years) : (A Cross Sectional Study)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Digital Analysis of Tooth Crown Dimensions of Primary Teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 33
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Egyptian children from the outpatient clinic of pediatric dentistry department Cairo University

Brief summary: Tooth size (Mesiodistal, Buccolingual and Occluso-gingival) has an important role in pediatric dentistry as it helps for fabrication of appropriate sizes of zirconia crowns for primary anterior teeth and Stainless-Steel crowns for primary posterior teeth. Tooth size differs among and within populations.


Eligibility criteria: Inclusion Criteria:

1. Children aged 4-6 years
2. Fully erupted first and second primary molars
3. Sound interproximal \& buccal / lingual walls with or without minimal occlusal pits \& fissure incipient caries.
4. No previous interproximal \& buccal / lingual restorations
5. Intact mesial and distal marginal ridge

Exclusion Criteria:

1. Children with gross carious lesions.
2. Children with hypo-mineralization, hypoplasia and fracture.
3. Children with mental disability.

Primary outcomes:
measure: tooth crown dimensions of primary teeth
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02844179: (+)-Alpha-Dihydrotetrabenazine Phase I
Official title: (+)-Alpha-Dihydrotetrabenazine Phase I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Adeptio Pharmaceuticals
First posted: 2016-07-26
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This research study is intended to determine the initial safety and tolerability of single oral doses of the drug (+)-alpha-dihydrotetrabenaxine (HTBZ) in normal volunteers. HTBZ is believed to be the active ingredient in the FDA-approved drug tetrabenazine (TBZ, brand name Xenazine), prescribed for treatment of involuntary movements in patients with Huntington's chorea. TBZ is a mixture of closely-related compounds (isomers) and is readily metabolized (converted) in the human body to HTBZ and related isomers. Investigators believe that HTBZ, the drug to be studied in this research, is the active ingredient in TBZ. The present study will confirm safety and tolerability of HTBZ and will investigate its expected effects on brain sites that are the target of TBZ therapy.


Eligibility criteria: Inclusion Criteria:

* able to provide informed consent

Exclusion Criteria:

* pregnant or lactating female subjects
* Subjects taking medications that interfere with VMAT2 (ex amphetamine)
* History of significant neurologic or psychiatric conditions
* Significant active medical conditions
* Alcohol or illicit substance use or dependence

Primary outcomes:
measure: VMAT2 occupancy by HTBZ determined by positron emission tomography (PET) scanning
timeFrame: 60 minutes post-administration of HTBZ
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan hospitals
state: Michigan
Study officials:
affiliation: University of Michigan
name: Kirk A Frey, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06317779: Evaluation of Laparoscopic Cholecystectomy and Concomitant Paraumbilical Hernia Repair
Official title: Evaluation of Laparoscopic Cholecystectomy and Concomitant Paraumbilical Hernia Repair
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Abdominal Disorder
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 50
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any age, any sex of patients with chronic calcular cholecystitis associated with para-umbilical hernia

Brief summary: Umbilical hernia frequently accompanies cholelithiasis. It is possible to repair these hernias after completing cholecystectomy.

Detailed description: Laparoscopy is a type of surgical procedure that allows a surgeon to access the inside of the abdomen and pelvis without having to make large incisions in the skin.

The use of laparoscopy in abdominal surgeries increases for its great benefits over open surgery as:

1)faster recovery, 2)shorter hospital stays 3)decrease blood loss, 4)decreased postoperative pain 5)earlier return to work and resumption of normal daily activity as well as, 6)cosmetic benefits. few studies discuss the efficacy and safety of using Laparoscopy in management of lap cholecyctectomy and concomitant paraumbilical hernia repair

Eligibility criteria: Inclusion Criteria:

* Any age, any sex of patients with chronic calcular cholecystitis associated with para-umbilical hernia

Exclusion Criteria:

* Patients with associated diseases such as chronic pulmonary disease, cardiac disease, chronic renal failure.

patients with strangulated para-umbilical hernia

patients with recurrent paraumbilical hernia

Primary outcomes:
measure: Evaluation of Laparoscopic cholecystectomy and concomitant paraumbilical hernia repair
timeFrame: Baseline
Secondary outcomes:
measure: Secondary outcomes measures
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
affiliation: General surgery
name: Ahmed M Ali
role: STUDY_DIRECTOR
References:
Clinical trial NCT06849479: Aerobic Exercises on Persisted Post Burn Anemia
Official title: Effect of Aerobic Exercises on Persisted Post Burn Anemia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Burns
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Fourty patients who have total body surface area ranged from 20% to 35% of burn, anemic and 8th to 16th week post burn will participate in this study, the patients will be randomly divided into two equal groups (20 patients for each group): Group A (Experimental Group) (Aerobic exercise and medical treatment):

Group B ( Control Group) (Medical treatment group):


Eligibility criteria: Inclusion Criteria:

The subject selection will be according to the following criteria:

1. Ages of patients will be ranged from 20 to 35 years.
2. All patients underwent severe burn with TBSA ranged from 20% to 35%.
3. 8 th to 16th week post burn.
4. All patients will be referred with persisted anemia by a surgeon before starting the study procedure.
5. All patients will enter the study having their informed consent

Exclusion Criteria:

The potential participants will be excluded if they meet one of the following criteria: 16

1. Patients with persisted pre burn anemia associated with systematic chronic disease such as coronary artery disease or chronic kidney disease.
2. Patients with pre burn persisted anemia associated with autoimmune disease such as Rheumatoid arthritis, Systemic lupus erythematosus ,Vasculitis, Sarcoidosis, Inflammatory bowel disease (IBD).
3. Unevaluated cardiac arrhythmia, Chronic bronchitis, poorly controlled type 1 diabetes, Extreme morbid obesity, Extreme underweight body mass index less than 12, Poorly controlled hypertension, Poorly controlled seizure disorder, Poorly controlled hyperthyroidism, Orthopedic limitation as fracture, .

Primary outcomes:
measure: Red blood cells
timeFrame: pre intervention and re assessed after 6 weeks of treatment
measure: Hemoglobin
timeFrame: pre intervention and re assessed after 6 weeks of treatment
measure: Hematocrit
timeFrame: pre intervention and re assessed after 6 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT05320679: Development of Pain Related Avoidance of Movement Questionnaire
Official title: Development and Implementation of Pain Related Avoidance of Movement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Musculoskeletal Pain
Low Back Pain
Back Pain
Keywords: Musculoskeletal pain
Kinesiophobia
Questionnaire
Lead sponsor: Hasan Kalyoncu University
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are going to be patients who have musculoskeletal pain problem.

Brief summary: In recent studies, it has been shown that people may have avoidance of movement due to pain. However, there is no scale that evaluates avoidance of movement due to pain in musculoskeletal problems. The aim of this study is to develop a scale to measure how much pain-related movement and activity is avoided in individuals with musculoskeletal pain, and to examine the results of its clinical application.

Detailed description: Approaches and methods to be applied in the research;

* Demographic information (age, gender, weight, height, pain location, pain duration and diagnose) form will be recorded.
* Creation of questionnaire items
* Reviewing of items/questions
* Patients who accept to fill out the questionnaire and who has complain of musculoskeletal pain will be asked to answer the questions.
* Editing the scale according to the answers
* Reliability and validity studies of the questionnaire
* Investigation of the results of applying the scale with clinical follow-up

To compare results of Pain-Related Avoidance of Movement Questionnaire following common used questionnaires are going to be used;

* Visual Analogue Scale (VAS)
* Tampa Kinesiophobia Scale
* Oswestry Low Back Pain and Disability Index-2.0

SPSS version 23 (SPSS Inc, Armonk, NY) program will be used in the analysis of the data.

Eligibility criteria: Inclusion Criteria;

* Having agreed to fill out the questionnaire
* Having pain caused by problems related to the musculoskeletal system
* Not having any disability in performing activities of daily living

Exclusion Criteria;

* Individuals who are not allowed to move due to pain
* If they have undergone surgery, individuals who have inconveniences in moving due to surgery
* Individuals who have cognitive problems in completing the questionnaire

Primary outcomes:
measure: Total points of Pain Related Avoidance of Movement Questionnaire
timeFrame: 1 week
Secondary outcomes:
measure: Change from baseline score in pain score
timeFrame: 1 week
measure: Change from baseline score in kinesiophobia score
timeFrame: 1 week
measure: Change from baseline in disability score
timeFrame: 1 week
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Hasan Kalyoncu University
Study officials:
References:
Clinical trial NCT03971279: Dexamethasone Intravitreal Implant (Ozurdex®) for Recurrent Vogt-Koyanagi-Harada (VKH) Disease Posterior Uveitis
Official title: Long Term Efficacy of Dexamethasone Intravitreal Implant (Ozurdex®) in Treatment of Recurrent VKH Uveitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Posterior Uveitis
Keywords: dexamethasone;VKH
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 16 patient with VKH disease who have recurrent attacks of posterio uveitis

Brief summary: VKH disease is a vision threatening condition.The investigators consider that ozurdex intravitreal implant is an effective line of treatment in recurrent VKH posterior uveitis.

Detailed description: Baseline ,and postoperative 1 ,6 ,12 and 24 months full ophthalmic examination was done.

Procedure included intravitreal injection of Dexamethasone implant 0.7 mg (Ozurdex(®); Allergan, Inc, Irvine, CA)

Eligibility criteria: Inclusion Criteria:

* Recurrent VKH posterior uveitis

Exclusion Criteria:

* retinal pathology, other causes of posterior uveitis

Primary outcomes:
measure: Best corrected visual acuity (BCVA)
timeFrame: 2 years
Secondary outcomes:
measure: optical coherence tomography (OCT) foveal thickness
timeFrame: 2 years
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: INMC
Study officials:
affiliation: Benha university faculty of medicine , INMC
name: Tarek Elhamaky
role: PRINCIPAL_INVESTIGATOR
References: