louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03653754: Growth and Body Composition in Children
Official title: Growth and Body Composition in Children With Disabilities and Typically Developing Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth
Child Development
Disability, Developmental
Keywords: growth
Body Composition
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 428
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Typically developing children who are in the 5th and 6th grades of elementary schools
2. Children with neurodevelopmental disabilities in a special school

Brief summary: This study is planned to measure and compare body composition indexes and growth between typically developing children and those with disabilities in South Korea for understanding the nutritional and growth status.

Detailed description: * Inclusion criteria for typically developing children

  1. typically developing children in 5th and 6th grades of elementary schools
  2. children whose parents checked the agreement form distributed by schools
* Inclusion criteria for children with disabilities

  1. children and adolescent who are in special schools
  2. children whose parents checked the agreement form distributed by schools
  3. children who were able to cooperate during the body composition analysis
* Exclusion criteria for both groups

  1. those whom do not have written informed consent
  2. who are not able to stay calmly during the body composition analysis
* All measurements done at two elementary schools on the day of the annual physical examination
* Measurement of height and body weight for growth
* Measurement of body composition index: Inbody 770 and Inbody S10, body composition analyzers

Eligibility criteria: Inclusion Criteria:

* Those who agreed to participate both parents and a child
* Typically developing children: among the 5th and 6th grade of two elementary schools.
* Children with neurodevelopmental disabilities: among the students in a special school.

Exclusion Criteria:

* Who do not want to participate
* Who are not possible to do the Inbody examination

Primary outcomes:
measure: BW
timeFrame: through study completion, an average of 1.5 month
Secondary outcomes:
measure: skeletal muscle mass (kg)
timeFrame: through study completion, an average of 1.5 month
measure: fat mass (kg)
timeFrame: through study completion, an average of 1.5 month
measure: height
timeFrame: through study completion, an average of 1.5 month
Other outcomes:
Locations:
city: Suwon-si
country: Korea, Republic of
facility: St. Vincent's Hospital, The Catholic University of Korea
Study officials:
affiliation: St. Vincent's hospital, The Catholic University of Korea
name: Bo Young Hong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06438354: Non-surgical Step 3 Periodontal Treatment With/Without Adjunctive Protocol - Pilot RCT.
Official title: Non-surgical Treatment of Residual Periodontal Pockets Using Sodium Hypochlorite/Amino Acid Gel and Cross-linked Hyaluronic Acid - a 9-month Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontal Pocket
Lead sponsor: University of Witten/Herdecke
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study conducted in patients recruited at private praxis setting after completed step 2 periodontal therapy. Residual pockets ≥4mm with positive bleeding or such \>5mm randomly allocated to either conventional subgingival re-instrumentation (controls) or to same mechanical treatment with adjectively applied hypochlorite/aminoacid gel for antiseptic reason followed by subginigival placement of cross linked hyaluronic acid gel for sealing the site after instrumentation. Re-evaluations at 3 and 9 months controlled for clinical parameters such as Periodontal Probing Depth (PPD) (CAL), Clinical Attachment Level, Gingival Recession (GR), Bleeding on Probing (BOP). The hypothesis is, sites treated with adjunctive protocol show greater PPD reduction and greater CAL gain at 9-month evaluation.


Eligibility criteria: Inclusion Criteria:

* systemically healthy individuals, smokers and non-smokers, HbA1c \<7.5%, compliant and adhering to systematic periodontal treatment protocol incl. SPT visits, patients willing to complete a 9-month post-op observation period

Exclusion Criteria:

* rheumatoid arthritis, HbA1c ≥7.5%, treatment of periodontitis within past 12 months, use of systemic antibiotics in past 6 months, pregnant and lactating individuals

Primary outcomes:
measure: Clinical Attachment Level
timeFrame: 9 month post-op
Secondary outcomes:
measure: Periodontal Probing Depth
timeFrame: 9 months post-op
measure: Gingival Recession
timeFrame: 9 months post-op
measure: Bleeding on Probing
timeFrame: 9 months post-op
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Implantat Competence Centrum München
Study officials:
References:
citation: Ramanauskaite E, Machiulskiene V, Shirakata Y, Dvyliene UM, Nedzelskiene I, Sculean A. Clinical evaluation of sodium hypochlorite/amino acids and cross-linked hyaluronic acid adjunctive to non-surgical periodontal treatment: a randomized controlled clinical trial. Clin Oral Investig. 2023 Nov;27(11):6645-6656. doi: 10.1007/s00784-023-05271-0. Epub 2023 Sep 23.
citation: Shirakata Y, Nakamura T, Setoguchi F, Imafuji T, Shinohara Y, Matsumura S, Iwata M, Noguchi K, Ramanauskaite E, Sculean A. Histological evaluation of nonsurgical periodontal treatment with and without the use of sodium hypochlorite / amino acids and cross-linked hyaluronic acid gels in dogs. Clin Oral Investig. 2024 Apr 27;28(5):281. doi: 10.1007/s00784-024-05674-7.
Clinical trial NCT03995654: Research of Burden of Interstititial Lung Diseases in Turkey
Official title: Research of Burden of Interstititial Lung Diseases in Turkey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Diseases, Interstitial
Fibrosis Lung
Keywords: Interstitial Lung Diseases
Fibrotic Lung
Prevalence
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be a multicenter prospective cross-sectional study in Turkey, that will be the coordinating center of our Department of Chest Diseases

Brief summary: The aim of our study is to investigate the etiological distribution of ILD, epidemiological characteristics of ILD cases such as age, gender, geography, smoking, occupation, economic status, education, and comorbidities. Another aim is to make the cost calculation from the first to the diagnosis in the patients diagnosed. Obtaining the missing data related to the ILD of our country is one of our goals.


Eligibility criteria: Inclusion Criteria:

* Patients who are not previously diagnosed with ILD will be included in the study.

Exclusion Criteria:

* under 18 years old
* older 80 years old

Primary outcomes:
measure: Etiological distribution
timeFrame: 1 year
measure: Etiological distribution
timeFrame: 1 year
measure: Epidemiological characteristics of ILD cases
timeFrame: 1 year
measure: Epidemiological characteristics of ILD cases
timeFrame: 1 year
measure: Epidemiological characteristics of ILD cases
timeFrame: 1 year
measure: Epidemiological characteristics of ILD cases
timeFrame: 1 year
measure: Epidemiological characteristics of ILD cases
timeFrame: 1 year
measure: Epidemiological characteristics of ILD cases
timeFrame: 1 year
measure: Total number
timeFrame: 1 year
Secondary outcomes:
measure: Clinical findings
timeFrame: 1year
measure: Pulmonary functions
timeFrame: 1year
measure: Pulmonary functions
timeFrame: 1year
measure: Pulmonary functions
timeFrame: 1year
measure: Pulmonary functions
timeFrame: 1year
measure: Pulmonary functions
timeFrame: 1year
measure: Pulmonary functions
timeFrame: 1year
measure: Diagnostic methods
timeFrame: 1year
measure: Time
timeFrame: 1year
measure: Treatment methods
timeFrame: 1year
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Department Of Chest Diseases, School Of medicine, Karadeniz Technical University
Study officials:
References:
Clinical trial NCT06508554: The Door to the Womb at Birth: Haptonomy
Official title: The Door to the Womb at Birth: Haptonomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Birth Outcome, Adverse
Self Efficacy
Memory Impairment
Pregnancy Related
Keywords: Haptonomy
Birth Expectation
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose: This study aimed to examine the effect of haptonomy application on the expectant mother's birth expectations, experiences, birth self-efficacy, birth memory and reminder during labor.

Materials and Methods: The prospective, double-blind, randomized controlled study is conducted between 10.10.2023-10.08.2024, with n=80 (40=control, 40=intervention) women volunteering to participate in the study randomly in two groups: intervention and control. In the study, the Personal Data Collection Form prepared by reviewing the literature, Wijma Birth Expectation/Experience Scale (W-DEQ) A and B version, Labor Self-Efficacy Scale (DEÖÖ) and Birth Memory and Recall Scale (DHÖ) were used.


Eligibility criteria: Inclusion Criteria:

* Married and pregnant women,
* ≥ 18 years old,
* Able to read, write and understand Turkish,
* Living in the city center where the study is conducted,
* Does not have any physical or psychological health problems for herself or her baby,
* Having a spontaneous pregnancy at 28.\< gestational weeks,
* Those who have not received haptonomy application before,
* Pregnant women who agreed to participate in the study were included.

Exclusion Criteria:

* Those with psychological and chronic health problems,
* Pregnant women who did not agree to participate in the study were not included.

Primary outcomes:
measure: Wijma Birth Expectation/Experience Scale (W-DEQ) A and B version
timeFrame: change before the application of the patent and after the 32nd, 34th, 36th, 38th weeks of pregnancy and the 1st day and 1st month postpartum.
measure: Self-Efficacy Scale in Labor
timeFrame: change before the application of the patent and after the 32nd, 34th, 36th, 38th weeks of pregnancy and the 1st day and 1st month postpartum.
measure: Birth Memory and Recall Scale
timeFrame: change before the application of the patent and after the 32nd, 34th, 36th, 38th weeks of pregnancy and the 1st day and 1st month postpartum.
Secondary outcomes:
Other outcomes:
Locations:
city: Bartin
country: Turkey
facility: Bartın University
Study officials:
References:
Clinical trial NCT00468754: A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine
Official title: A Study Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections With Insulin Lispro and Glargine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 1
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This trial will compare the metabolic control in type 1 diabetes obtained by continuous infusion of insulin lispro with that obtained by multiple daily injections of insulin lispro and glargine, a long-acting insulin analogue. Patients will be switched to the alternative treatment after 4 months. Glucose variability in the last month of each treatment will be analyzed.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetic patients, 18-60 years of age
* Diabetic for \>2 years
* Treated with CSII for \>=6 months
* HbA1c \<8.5%

Exclusion Criteria:

* Treatment with daily insulin injections
* Inability to handle pump therapy
* Untreated retinopathy

Primary outcomes:
measure: Variability of blood glucose characterised by the standard deviation of the mean blood glucose
timeFrame: Length of study
Secondary outcomes:
measure: HbA1c
timeFrame: Length of study
measure: Mean BG during the last month of the respective treatment period
timeFrame: Length of study
measure: Frequency of severe hypoglycemia
timeFrame: Length of study
measure: Daily insulin requirement
timeFrame: Length of study
Other outcomes:
Locations:
city: Bergamo
country: Italy
city: Brescia
country: Italy
city: Padova
country: Italy
city: Pisa
country: Italy
Study officials:
affiliation: Disetronic Medical Systems AG
name: Andreas Buhr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01211054: Epidemiologic Analysis for the Prevalence of Chronic Airway Diseases in Old Population
Official title: Epidemiologic Analysis for the Prevalence of Chronic Airway Diseases in Old Population in Korea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: General Population, Spirometric Data, Medical Records
Lead sponsor: Chonbuk National University
Sponsor class: OTHER
First posted: 2010-09-29
Enrollment: 500
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: For old people aged 60 yrs or more, the investigators will analyze their respiratory symptoms, spirometric data, smoking history, and atopic history in Korea.

Brief summary: Aim: To evaluate the spirometric data and the prevalence of chronic airway disease in old population (\> 60 yrs) in Korea.

List to do

1. History taking
2. physical examination
3. Routine blood test
4. All spirometric data
5. In subgroup: further evaluation of allergic airway disease


Eligibility criteria: Inclusion Criteria:

* \> 60 yrs olds
* no known specific respiratory diseases

Exclusion Criteria:

* taking any medication for respiratory diseases
* History of diagnosis as a respiratory disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02752854: Pain Threshold Measurements in High and Low Altitude Among Healthy Volunteer Adults: A Comparative Study
Official title: Pain Threshold Measurements in High and Low Altitude Among Healthy Volunteer Adults: A Comparative Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Keywords: pain scores
pressure algometer
healthy volunteer adults
Lead sponsor: Taif University
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 484
Sex: ALL
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteer adults

Brief summary: one measurement of pain threshold in high altitude and in low altitude using pressure algometer and Situational pain scale.

Detailed description: the aim of the study is to compare between pain threshold in high 1.9000 m above sea level and low altitude at sea level in healthy volunteer adults.

Assessment performed using:

1. pressure algometer.
2. situational pain scale

Eligibility criteria: Inclusion Criteria:

* age 18-52 years old.
* healthy volunteers

Exclusion Criteria:

* no musculoskeletal problems including muscle spasm
* no recent injuries or operations.
* not suffering from any painful condition.
* not on pain medications or antidepressant

Primary outcomes:
measure: Pain threshold assessed with a pressure algometer
timeFrame: 1 year
Secondary outcomes:
measure: situational pain scale
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Head of scientific research board
name: Amro A Almaz, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06525454: Individualized Automatic Target Coaching Message for Glycemic Management and Depressive Symptom
Official title: Feasibility and Acceptability of Individualized Automatic Target Coaching Message Based on the Metrics of Continuous Glucose Monitoring and Depressive Symptom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:2 ratio
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a single-center, randomized, prospective, feasibility and acceptability trial in patients with type 1 diabetes. For six weeks, the intervention group will receive weekly personalized coaching messages for glycemic management based on blood data from continuous glucose monitors and bi-weekly personalized coaching messages for depression management based on depression questionnaires. The control group will remain on their current treatment and will not receive any intervention. The purpose of this trial is to evaluate the feasibility and acceptability of the clinical application of automated, personalized coaching messages for glycemic management and depressive symptom in people with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Patients who are determined to use continuous glucose monitoring based on their physician's medical judgment.
* Patients with type 1 diabetes, age 20-69 years old
* Currently receiving treatment with multiple insulin injection therapy
* Patients who have access to KakaoTalk via smartphone and are able to communicate with it
* Voluntarily agreed to participate in this clinical study.

Exclusion Criteria:

* Subjects using oral hypoglycemic agents
* Steroid and immunosuppressant users
* Subjects receiving anticancer medications
* Breastfeeding or pregnant patients
* Patients who do not voluntarily consent to the study
* Anyone deemed unsuitable by the investigator to participate in the study

Primary outcomes:
measure: Time In Range
timeFrame: Week 6
Secondary outcomes:
measure: Diabetes treatment satisfaction
timeFrame: Week 6
measure: Depressive symptoms
timeFrame: Week 6
measure: Time In Tight Range
timeFrame: Week 6
measure: Time Above Range
timeFrame: Week 6
measure: Time Below Range
timeFrame: Week 6
measure: Coefficient of Variation
timeFrame: Week 6
measure: Glycemic Management Indicator
timeFrame: Week 6
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT05131854: Incidence , Risk Factors and Outcomes of Haemodynamic Instability and Cardiac Arrest During Spine Surgery
Official title: Incidence , Risk Factors and Outcomes of Haemodynamic Instability and Cardiac Arrest During Spine Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spine Surgery
Keywords: spine surgery , bradycardia , cardiac arrest
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2021-11-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: population candidated for spine surgery

Brief summary: Risk factors for cardiac arrest during spine surgery have been well defined, including lumbar fusion, age over 65 years, obesity, cardiovascular disease, ethnicity and ASA status. Bradycardia and asystole have been described under general anaesthesia in combined surgical cohorts: Proposed mechanisms include unopposed parasympathetic activation, enhanced vasovagal response to decreased venous return, and psychiatric stressors. The investigators prospectively will review patients candidates for spine surgery to explore potential incidence, contributory factors and outcomes to unexpected transient intraoperative haemodynamic instability, arrhythmia, and cardiac arrest during spine surgery as these data are needed to aid risk stratification and improve decision making for spine care teams.


Eligibility criteria: Inclusion Criteria:

1. Aged more than 18
2. Gender: both.
3. ASA grade I-II (American society of anesthiologists).
4. Prepared to spine surgery under general anesthesia

Exclusion Criteria:

1. Ischemic heart patients
2. Hypertensive patients
3. Patients with atrial fibrillation or any previous history of attack of arrhythmias
4. Patients on B.B ( beta-blockers)
5. Chronic use of neuropsychiatric medications
6. Renal Impairment
7. Liver Dysfunction.
8. Any complications during the procedure as massive hemorrhage
9. Surgery for traumatic spinal cord

Primary outcomes:
measure: Incidence of Haemodynamic Instability during Spine Surgery
timeFrame: allover one year
measure: Risk factors of Haemodynamic Instability during Spine Surgery
timeFrame: allover one year
measure: outcomes of Haemodynamic Instability during Spine Surgery
timeFrame: allover one year
measure: Incidence of cardiac arrest during Spine Surgery
timeFrame: allover one year
measure: Risk factors of cardiac arrest during Spine Surgery
timeFrame: allover one year
measure: outcomes of Cardiac Arrest during Spine Surgery
timeFrame: allover one year
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig university
Study officials:
References:
Clinical trial NCT01062854: Effects of Earplugs on Sleep and Sleep Apnea
Official title: Effects of Earplugs on Sleep and Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disordered Breathing
Keywords: snoring, sleep disordered breathing, polysomnography, sleep fragmentation
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2010-02-04
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The main goal of this study is to assess whether use of earplugs has any effect on sleep, sleep apnea, and daytime sleepiness in individuals who snore.


Eligibility criteria: Inclusion Criteria:

* Adults, ages 18 or older
* Scheduled at the University of Michigan Sleep Disorders Center for a diagnostic polysomnogram to evaluate for sleep-disordered breathing

Exclusion Criteria:

* Medical, psychiatric or other conditions that would interfere with interpretation of the results of the sleep studies or the subject's ability to complete the Stanford Sleepiness Scale

Primary outcomes:
measure: Sleep measures (rates of apneas and hypopneas, oxygen desaturation, arousals, sleep stages, respiratory cycle-related EEG changes [RCREC])
timeFrame: up to 2 years after the sleep study
Secondary outcomes:
measure: Subjective sleepiness measures (Stanford Sleepiness Scale)
timeFrame: on awakening after the sleep study
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Sleep Disorders Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Ronald D Chervin, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chirakalwasan N, Ruzicka DL, Burns JW, Chervin RD. Do snoring sounds arouse the snorer? Sleep. 2013 Apr 1;36(4):565-71. doi: 10.5665/sleep.2546.